1. SHANGHAI, April 6,, 2021 /PRNewswire/ -- Shanghai Genechem Co., Ltd. (Genechem), a discovery company dedicated to novel drug target discovery and development of novel therapeutics, today announced the execution of a global collaboration with I-Mab (NASDAQ:IMAB), a Nasdaq-listed global biopharmaceutical company, to develop and commercialize multiple bi-specific antibodies (BsAb) based on monoclonal antibody developed by Genechem and antibodies selected by I-MAB.  

    "This collaboration is the first of many that will leverage Genechem's Good Research Practice (GRP) and CHAMP antibody discovery platform, strong bioinformatic database, as well as strong development expertise of synergistic partners, to deliver globally competitive assets based on…

    SHANGHAI, April 6,, 2021 /PRNewswire/ -- Shanghai Genechem Co., Ltd. (Genechem), a discovery company dedicated to novel drug target discovery and development of novel therapeutics, today announced the execution of a global collaboration with I-Mab (NASDAQ:IMAB), a Nasdaq-listed global biopharmaceutical company, to develop and commercialize multiple bi-specific antibodies (BsAb) based on monoclonal antibody developed by Genechem and antibodies selected by I-MAB.  

    "This collaboration is the first of many that will leverage Genechem's Good Research Practice (GRP) and CHAMP antibody discovery platform, strong bioinformatic database, as well as strong development expertise of synergistic partners, to deliver globally competitive assets based on innovative targets. We are excited to collaborate with I-Mab, a global leader in Oncology and antibody development, to bring more products to address clinical unmet needs for patients in China and globally", commented Yueqiong Cao, Founder and CEO of Genechem.

    About Shanghai Genchem Co., Ltd. (Genechem)

    Genechem is a leading innovation research company focused on target discovery/validation, development of antibody and cell therapy products against novel targets, and partnership globally to maximize its portfolio. Founded in 2002, now with over 500 employees, Genechem works closely with Research Oncologists to translate clinical research into therapeutics addressing high clinical unmet needs, leveraging its strong network of Research Oncologists in over 300 hospitals and Good Research Practice (GRP platform) which includes comprehensive RNAi library, tools including genetic typing, bioinformatic analysis, genetic manipulation, as well as SOP and project management systems. For more information, visit http://www.gcbio.com/.

    Contact:

    Dr. Tong Zhang

    Chief Business Officer

    Shanghai Genechem Co., Ltd



    +86-18501607878

    Cision View original content:http://www.prnewswire.com/news-releases/shanghai-genchem-co-ltd-genechem-announces-global-collaboration-on-bispecific-antibodies-301263158.html

    SOURCE Shanghai Genchem Co., Ltd. (Genechem)

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  2. SHANGHAI, China and GAITHERSBURG, Md. and SEONGNAM, South Korea, April 06, 2021 (GLOBE NEWSWIRE) -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, and ABL Bio, Inc. (Kosdaq:298380, hereafter "ABL"), a South Korean biotech specializing in bispecific antibody technology, jointly announced that the first patient has been dosed in a phase 1 trial for bispecific antibody TJ-L14B/ABL503. The phase 1 clinical trial is an open-label, multi-center, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), preliminary antitumor activity, maximum tolerated dose (MTD) and/or…

    SHANGHAI, China and GAITHERSBURG, Md. and SEONGNAM, South Korea, April 06, 2021 (GLOBE NEWSWIRE) -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, and ABL Bio, Inc. (Kosdaq:298380, hereafter "ABL"), a South Korean biotech specializing in bispecific antibody technology, jointly announced that the first patient has been dosed in a phase 1 trial for bispecific antibody TJ-L14B/ABL503. The phase 1 clinical trial is an open-label, multi-center, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), preliminary antitumor activity, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of TJ-L14B/ABL503 in locally advanced or metastatic solid tumors (NCT04762641).

    Being developed jointly with ABL, TJ-L14B/ABL503 is a differentiated PD-L1-based bispecific antibody with the PD-L1 arm as the tumor-dependent T-cell activator and the 4-1BB arm as the conditional T cell activator upon tumor engagement. Using ABL's ‘Grabody-T' bispecific antibody platform technology, TJ-L14B/ABL503 stimulates 4-1BB activation only in the presence of PD-L1 expressing tumor cells to minimize the risk of off-tumor toxicity. Preclinical studies have demonstrated that the bispecific antibody shows better anti-tumor activity than equimolar doses of single agents alone or in combination.

    "Immune checkpoint inhibitors, such as PD-L1, have created a new paradigm for cancer treatment; however, they have limitations in their efficacy and response rates," said Dr. Joan Shen, CEO of I-Mab. "Co-targeting of PD-L1 with a bispecific antibody molecule using this particular platform is postulated to enhance antitumor activity while ensuring the safety of the patients. It may provide an alternative therapeutic approach for patients who have not responded to existing treatments."

    "We are very pleased to advance the clinical development of TJ-L14B/ABL503 as planned," said Dr. Sang Hoon Lee, CEO of ABL. "With phase 1 trial for TJ-L14B/ABL503 being the first testbed for our Grabody-T bispecific antibody platform, we look forward to validating our company's technology in the field of cancer immunotherapy."

    "We are excited to be the first center to conduct this study for TJ-L14B/ABL503," said Dr. Anthony W. Tolcher, FRCPC, FACP, CEO and director of clinical research at NEXT Oncology. "TJ-L14B/ABL503 has demonstrated potential to overcome the adverse toxicity issues of anti-4-1BB antibodies. In collaboration with I-Mab and ABL, we hope for a thorough evaluation to deliver a highly promising treatment for the benefit of cancer patients." NEXT Oncology is a phase 1 center in the U.S. dedicated to providing patients with advance cancer access to the newest cancer treatments available.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in immuno-oncology therapeutic area. The Company's mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company's unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedInTwitter and WeChat.

    About ABL Bio

    ABL Bio, Inc. (Kosdaq: 298380) is a South Korean biotechnology company developing antibody therapeutics for immuno-oncology and neurodegenerative diseases. With internal R&D and global partnerships, ABL has developed multiple BsAb platforms, such as ‘Grabody-T,' ‘Grabody-I' and ‘Grabody-B' and built an innovative pipeline of multiple clinical and pre-clinical stage drug candidates. In the oncology area, we have developed Grabody-T, a modular 4-1BB engaging platform that has demonstrated superior efficacy and safety. In the neurodegenerative disorder space, we have developed Grabody-B platform, which is designed to maximize blood-brain barrier (BBB) penetration. Grabody-B is applicable to various CNS targets across a plethora of neurological disorders, potentially providing a breakthrough to address the high unmet medical needs in neurodegeneration. For more information, please visit www.ablbio.com

    I-Mab Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the TJ-L14B clinical trials, the potential implications of clinical data for patients, and the advancement by I-Mab and ABL, and anticipated clinical development, regulatory milestones and commercialization of TJ-L14B. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to the ability of I-Mab and ABL to demonstrate the safety and efficacy of TJ-L14B; the clinical results for the drug candidate, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of the drug candidate; the ability to achieve commercial success for the drug candidate, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    ABL Forward Looking Statements

    Statements in this press release contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform act of 1995. Words such as "will," "could," "hope," "expect," "plan" and similar expressions that are based on ABL's current expectations and assumptions are subject to risks and uncertainties that are difficult to predict. The risks and uncertainties include but are not limited to, potential delays in clinical trial recruitment and participation; ABL and I-Mab's ability to demonstrate the safety and efficacy of ABL503; adverse results in the clinical development process; changes in expected or existing competition; changes in the biopharmaceutical landscape; ABL's ability to obtain and maintain protection of intellectual property for its technology and drugs; ABL's reliance on third parties to conduct drug development; the company's financial position; future decisions by the FDA or other regulatory authorities; volatile global economic conditions; and the impact of the global COVID-19 pandemic. The reader is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to ABL and the company assumes no obligation to provide public updates to these forward-looking statements that are only as of the date of this press release, even if new information is available in the future.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail: 

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail: 

    Office line: +86 21 6057 5785

    Investor Inquiries:

    The Piacente Group, Inc.

    Emilie Wu

    E-mail: 

    Office line: +86 21 6039 8363

    ABL Contacts

    Jaecheon Jerry Lee

    Chief Financial Officer



    +82 31 8018 9802

    Investor Inquiries:

    Hyunjun Kim



    +82 31 8018 9845



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  3. SHANGHAI, China and GAITHERSBURG, Md., March 31, 2021 (GLOBE NEWSWIRE) -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologic, today announced its participation in the following conferences in April. Details of the conferences and management presentation are as follows:

    20th Annual Needham Healthcare Conference (Virtual)
    Presentation: Tuesday, April 13, 2021 at 8:45 a.m. ET
    Presenter: Dr. Jingwu Zang, Founder, Chairman and Director

    Webcast link: https://wsw.com/webcast/needham107/imab/2212474. The webcast will also be available under "Event Calendar" on IMAB's IR website at http://ir.i-mabbiopharma.com/.

    One-on-one meetings: April 12-15…

    SHANGHAI, China and GAITHERSBURG, Md., March 31, 2021 (GLOBE NEWSWIRE) -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologic, today announced its participation in the following conferences in April. Details of the conferences and management presentation are as follows:

    20th Annual Needham Healthcare Conference (Virtual)

    Presentation: Tuesday, April 13, 2021 at 8:45 a.m. ET

    Presenter: Dr. Jingwu Zang, Founder, Chairman and Director

    Webcast link: https://wsw.com/webcast/needham107/imab/2212474. The webcast will also be available under "Event Calendar" on IMAB's IR website at http://ir.i-mabbiopharma.com/.

    One-on-one meetings: April 12-15, 2021

    Management participants: Dr. Jingwu Zang, Founder, Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Ms. Leah Liu, Senior Director Investor Relations

    For more information, please contact your Needham representative.

    2021 Haitong Securities Spring Listed Companies Conference

    Presentation: Thursday, April 15, 2021 at 11:00 a.m. Beijing Time

    Presenter: Ms. Leah Liu, Senior Director Investor Relations

    Location: Hangzhou

    One-on-one and small group meetings: April 14-16, 2021

    Management participant: Ms. Leah Liu, Senior Director Investor Relations

    For more information, please contact your Haitong representative.

    UBS Healthcare Summit 2021 (Virtual)

    Management participants: Dr. Jingwu Zang, Founder, Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Ms. Leah Liu, Senior Director Investor Relations

    One-on-one and small group meetings: April 27-29, 2021

    For more information, please contact your UBS representative.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in immuno-oncology therapeutic area. The Company's mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company's unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedInTwitter and WeChat.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail: 

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail: 

    Office line: +86 21 6057 5785

    Investor Inquiries:

    The Piacente Group, Inc.

    Emilie Wu

    E-mail: 

    Office line: +86 21 6039 8363 



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  4. SHANGHAI, China and GAITHERSBURG, Md., March 30, 2021 (GLOBE NEWSWIRE) -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical-stage biopharmaceutical company committed to the development of novel biologics, and ABL Bio, Inc. (Kosdaq:298380, hereafter "ABL"), a South Korean biotech specializing in bispecific antibody technology, jointly announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for initiating phase 1 trial for bispecific antibody TJ-CD4B/ABL111. The phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TJ-CD4B/ABL111 in advanced or metastatic solid tumors.

    TJ-CD4B/ABL111 is a novel bispecific antibody that works…

    SHANGHAI, China and GAITHERSBURG, Md., March 30, 2021 (GLOBE NEWSWIRE) -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical-stage biopharmaceutical company committed to the development of novel biologics, and ABL Bio, Inc. (Kosdaq:298380, hereafter "ABL"), a South Korean biotech specializing in bispecific antibody technology, jointly announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for initiating phase 1 trial for bispecific antibody TJ-CD4B/ABL111. The phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TJ-CD4B/ABL111 in advanced or metastatic solid tumors.

    TJ-CD4B/ABL111 is a novel bispecific antibody that works through binding to a tumor antigen Claudin 18.2 (CLDN18.2) which is selectively expressed in several cancers and to 4-1BB, a co-stimulatory molecule expressed on T cells, to activate immune response within tumor for better anti-tumor activity. Preclinical studies demonstrate that TJ-CD4B/ABL111 has superior anti-tumor property as compared to the two monoclonal antibodies when acting alone or in combination. This superior anti-tumor activity is achieved locally on tumor site, thus minimizing the risk of liver and systemic side effects commonly associated with 4-1BB antibody when used alone.

    "With its high specificity and novel properties, TJ-CD4B/ABL111 could have significant advantages over other 4-1BB monoclonal antibodies in terms of the efficacy and toxicities. It could become a key player against various advanced cancers. We are very excited about the initiation of the clinical study and hope to bring this highly valuable compound to the cancer patients with the critical unmet needs," said Dr. Taylor Guo, chief scientific officer of I-Mab.

    "With the FDA approval of the IND application to initiate a phase 1 clinical trial of TJ-CD4B/ABL111, we expect to progress rapidly with the clinical development of TJ-CD4B/ABL111," said Dr. Sang Hoon Lee, Founder and CEO of ABL. "In partnership with I-Mab, we look forward to providing a superior therapeutic option for patients with advanced and metastatic solid cancers."

    The phase 1 clinical study will be a multi-center, dose escalation study in the U.S. I-Mab also plans to conduct dose expansion studies for TJ-CD4B/ABL111 in patients with gastric cancers, gastro-esophageal junction adenocarcinoma, esophageal adenocarcinoma and pancreatic ductal adenocarcinoma in China later this year.

    About TJ-CD4B/ABL111

    TJ-CD4B, also known as ABL111, is a Claudin 18.2 and 4-1BB bispecific antibody capable of binding to tumor cells expressing Claudin 18.2, i.e., gastric cancer and pancreatic cancer cells, and stimulating intra-tumoral T cells by the 4-1BB arm designed to be activated only upon tumor engagement whilst silent elsewhere. TJ-CD4B effectively maintains a strong tumor binding property and anti-tumor activity attributable to a synergistic effect of both Claudin 18.2 antibody and 4-1BB antibody while it avoids or minimizes liver toxicity and systemic immunotoxicity commonly seen with 4-1BB antibodies as a drug class. TJ-CD4B is being developed under collaboration between I-Mab and ABL.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in immuno-oncology therapeutic area. The Company's mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company's unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedInTwitter and WeChat.

    About ABL Bio

    ABL Bio, Inc. (Kosdaq: 298380) is a South Korean biotechnology company developing antibody therapeutics for immuno-oncology and neurodegenerative diseases. With internal R&D and global partnerships, ABL has developed multiple BsAb platforms, such as ‘Grabody-T,' ‘Grabody-I' and ‘Grabody-B' and built an innovative pipeline of multiple clinical and pre-clinical stage drug candidates. In the oncology area, we have developed Grabody-T, a modular 4-1BB engaging platform that has demonstrated superior efficacy and safety. In the neurodegenerative disorder space, we have developed Grabody-B platform, which is designed to maximize blood-brain barrier (BBB) penetration. Grabody-B is applicable to various CNS targets across a plethora of neurological disorders, potentially providing a breakthrough to address the high unmet medical needs in neurodegeneration. For more information, please visit www.ablbio.com

    I-Mab Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the TJ-CD4B clinical trials, the potential implications of clinical data for patients, and the advancement by I-Mab and ABL, and anticipated clinical development, regulatory milestones and commercialization of TJ-CD4B. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to the ability of I-Mab and ABL to demonstrate the safety and efficacy of TJ-CD4B; the clinical results for the drug candidate, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of the drug candidate; the ability to achieve commercial success for the drug candidate, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    ABL Forward Looking Statements

    Statements in this press release contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform act of 1995. Words such as "will," "could," "hope," "expect," "plan" and similar expressions that are based on ABL's current expectations and assumptions are subject to risks and uncertainties that are difficult to predict. The risks and uncertainties include but are not limited to, potential delays in clinical trial recruitment and participation; ABL and I-Mab's ability to demonstrate the safety and efficacy of ABL111; adverse results in the clinical development process; changes in expected or existing competition; changes in the biopharmaceutical landscape; ABL's ability to obtain and maintain protection of intellectual property for its technology and drugs; ABL's reliance on third parties to conduct drug development; the company's financial position; future decisions by the FDA or other regulatory authorities; volatile global economic conditions; and the impact of the global COVID-19 pandemic. The reader is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to ABL and the company assumes no obligation to provide public updates to these forward-looking statements that are only as of the date of this press release, even if new information is available in the future.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail: 

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail: 

    Office line: +86 21 6057 5785

    Investor Inquiries:

    The Piacente Group, Inc.

    Emilie Wu

    E-mail: 

    Office line: +86 21 6039 8363

    ABL Contacts

    Jaecheon Jerry Lee

    Chief Financial Officer



    +82 31 8018 9802

    Investor Inquiries:

    Hyunjun Kim



    +82 31 8018 9845



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    • 18 significant clinical milestones achieved since the Company's IPO in January 2020, with multiple important data readouts for lemzoparlimab (TJC4), uliledlimab (TJD5) and other clinical assets expected in 2021
    • New drug application (NDA) submission for felzartamab (TJ202) CD38 antibody for treatment of relapsed or refractory multiple myeloma on track for 2021

    • Achieved corporate profitability, delivering full-year net revenues of RMB 1,542.7 million (US $236.4 million), net income per ADS of RMB 8.07 (US $1.24) on a GAAP basis and net income per ADS of RMB 17.09 (US $2.62) on a non-GAAP basis

    • Total cash position of RMB 4.8 billion (US $734.1 million) driven by Hillhouse-led PIPE financing and AbbVie licensing payments sufficient to fund operations
    • 18 significant clinical milestones achieved since the Company's IPO in January 2020, with multiple important data readouts for lemzoparlimab (TJC4), uliledlimab (TJD5) and other clinical assets expected in 2021
    • New drug application (NDA) submission for felzartamab (TJ202) CD38 antibody for treatment of relapsed or refractory multiple myeloma on track for 2021



    • Achieved corporate profitability, delivering full-year net revenues of RMB 1,542.7 million (US $236.4 million), net income per ADS of RMB 8.07 (US $1.24) on a GAAP basis and net income per ADS of RMB 17.09 (US $2.62) on a non-GAAP basis



    • Total cash position of RMB 4.8 billion (US $734.1 million) driven by Hillhouse-led PIPE financing and AbbVie licensing payments sufficient to fund operations through 2023



    • Landmark global collaboration with AbbVie to develop and commercialize lemzoparlimab, a highly differentiated CD47 antibody, and potentially second generation CD47-based bi-specific antibodies



    • New discovery initiative to expand transformational immuno-oncology pipeline



    • Dual listing(s) in Greater China under consideration to support long-term growth



    • I-Mab to host conference call and webcast on March 29 at 8:00 a.m. ET

    SHANGHAI, China and GAITHERSBURG, Md., March 29, 2021 (GLOBE NEWSWIRE) -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced financial results for the full year ended December 31, 2020 and provided key business updates.

    "In an unprecedented year marked by the global pandemic, I-Mab outperformed in delivering outstanding results to accelerate our progress towards becoming a fully-integrated global biopharma company," said Dr. Jingwu Zang, Founder, Chairman and Director of I-Mab. "We have accomplished 18 significant clinical milestones since our IPO last year and our pipeline today has advanced to include three registrational trials with the first NDA planned later this year for a total 19 clinical trials either on-going or to be initiated in both the United States and China."

    I-Mab's globally competitive pipeline has now progressed to include 16 novel or highly differentiated assets with 11 in clinical development stages and five in the pre-clinical stage. The Company's pre-NDA and core clinical assets of near-term value realization, including felzartamab (TJ202) and eftansomatropin alfa (TJ101), are progressing towards NDA. In addition, two highly differentiated investigational drugs, lemzoparlimab (TJC4) and uliledlimab (TJD5), have achieved critical progress as global front-runners. I-Mab's next wave of innovative assets, epitomized by the novel bispecific antibodies TJ-L14B and TJ-CD4B, are now moving into clinical trials in the U.S.

    In the near-term, I-Mab will continue creating corporate value by delivering on a series of critical milestones including the planned NDA submission for felzartamab in 2021 as well as forging potential strategic global out-licensing partnerships for uliledlimab and other innovative assets and selected in-licensing partnerships to enrich its pipeline. The focused R&D effort is further complemented by the Company's new discovery initiative to create the next generation of innovative assets through transformative platform technologies.

    "We are confident in our innovative R&D strength in immuno-oncology to continue advancing and upgrading our globally competitive pipeline." Dr. Zang concluded.

    In addition to creating the near-term value, the Company has also made notable strides in its journey to become a global biopharmaceutical company, which include building a state-of-the-art GMP manufacturing facility in China with a pilot plant and commercial scale production lines.

    In parallel, I-Mab has begun to execute a commercialization plan that focuses on building a leading position in hematologic oncology in China, leveraging I-Mab's core assets (i.e., felzartamab and lemzoparlimab) and additional key product(s) to be in-licensed. As both assets are progressing towards NDA, preparations are being made for product launch and commercialization. Our revenue stream generated from out-licensing deals grew tremendously in 2020 to make I-Mab profitable for the first time and is expected to converge with product sales revenues to be generated in a near term, projecting a promising financial outlook for the Company and its shareholders.

    Overview of Operations

    I-Mab currently has three registrational trials underway, 16 phase 1 and 2 clinical studies - either ongoing or to be initiated soon in both the U.S. and China – and five on-going pre-clinical programs in 2021. Four additional new discovery programs are set to advance to the pre-clinical development stage by the end of 2021 as a result of the new discovery initiative.

    I-Mab has achieved critical advancements in core clinical assets in early 2021. These achievements include the full patient enrollment for felzartamab in the third-line multiple myeloma trial, a key step for the NDA submission that is on track for late 2021, and the initiation to enroll patients for the registrational clinical trial of eftansomatropin alfa. The Company has also set forth with its accelerated clinical development plan for lemzoparlimab, aiming for NDA approval as the first CD47 antibody drug for the treatment of hematologic malignancies (such as MDS, AML and NHL) in China while continuing to advance clinical trials in solid tumors in combination with PD-1 therapy.

    These clinical trials are on-going in the U.S. and China with preliminary data readouts planned in Q4 2021 for the non-Hodgkin's lymphoma (NHL) study and the solid tumor study in the U.S. The Company also plans to initiate a combination clinical trial of lemzoparlimab with felzartamab as a possible novel treatment option for relapsed and refractory and newly diagnosed MM with a potential to become first-line treatment if proven in addition to felzartamab currently being evaluated as a second-line and third-line treatment for MM.

    For uliledlimab, a globally competitive and differentiated CD73 antibody, the Company recently completed a phase 1 clinical study in the U.S., which demonstrated favorable safety, PK/PD and receptor occupancy profile, together with observed clinical activity of the investigational drug in cancer patients. The detailed clinical data have been submitted for presentation at ASCO 2021. In addition, a combined phase 1/2 clinical trial has been ongoing and the dose expansion part of the trial will be initiated in combination with PD-1 therapy in patients with cancers in China in 2H 2021.

    Already operating globally with five hubs in China and the U.S., I-Mab has plans to open a new R&D center in San Diego, CA, focusing on translational medicine and formulation research. In preparation for the market launch of its initial series of products in China, the Company is in construction of a comprehensive biologics manufacturing facility in Hangzhou, China, and is building up its commercialization capabilities.

    To support its long-term growth, I-Mab is actively monitoring market conditions and considering potential options for further equity listings on Greater China stock exchanges such as the STAR Market in Shanghai and the Main Board of the Hong Kong Stock Exchange under Chapter 18A of the Hong Kong Listing Rules.  

    Recent Pipeline Highlights and Upcoming Milestones

    Core Clinical Assets – Global Frontrunners

    • Lemzoparlimab (TJC4): A highly differentiated CD47 antibody being developed for oncology indications. The results of the US phase 1 clinical trial in patients with solid tumor indicate potential clinical advantages of lemzoparlimab in safety and PK with observed clinical activity, which does not require priming dose as compared to other clinical stage CD47 antibodies. Lemzoparlimab is being developed through a comprehensive clinical development plan for hematologic oncology and solid tumor in global collaboration with AbbVie.



      • Global Collaboration with AbbVie: In September 2020, to facilitate and accelerate the global development and commercialization of lemzoparlimab, I-Mab granted AbbVie a global license valued at US$1.94 billion, including an upfront payment of US$180 million and the first milestone payment of US$20 million based on the phase 1 clinical results. I-Mab retains the rights to develop and commercialize lemzoparlimab in Mainland China, Hong Kong and Macau. We believe that this global collaboration with AbbVie will greatly facilitate the clinical development, manufacturing and commercialization of lemzoparlimab globally and in China.



      • Hematologic malignancies: Our prioritized development goal is to achieve an accelerated approval of lemzoparlimab in China, ideally as the first CD47 antibody product in China. MDS and possibly NHL are being considered as potential first indication(s) as they hold the high probability of success for accelerated approvals.



      • (1) With the approved IND, the Company is initiating an abbreviated phase 2 clinical study of lemzoparlimab in combination with AZA in patients with AML and MDS, potentially bridging the clinical study – pending approval by the National Medical Products Administration (NMPA) - to a registrational clinical trial in patients with MDS.



        (2) The Company continues to enroll more patients with NHL in a combination clinical trial with rituximab (Rituxan®) in the U.S. This clinical trial includes clinical sites in China through an IMCT (international multi-center trial) mechanism in order to potentially bridge – pending approval by the NMPA - to a registrational clinical trial in NHL in China. The preliminary data readout of the NHL trial is set in Q4 2021.



        (3) The Company will participate in a global clinical trial to be led by AbbVie in patients with AML for registrational purposes globally by AbbVie and in China by I-Mab.
    • Solid tumor indications: The Company will continue advancing the current cohort expansion study in the U.S., combining lemzoparlimab with pembrolizumab (Keytruda®) to evaluate the safety and efficacy in patients with NSCLC and ovarian cancer. The results of this on-going clinical study are anticipated in Q4 2021. In addition to the on-going US clinical trial, we are in preparation of an IND submission to China's NMPA to initiate a phase 2 "basket" clinical trial in patients with advanced solid tumors in 2H 2021.



    • Combination therapy with the existing assets for potential new treatment options: Pre-clinical data generated internally and reported by others support the hypothesis that lemzoparlimab may work additive with other immune pathways, such as the CD38 pathway for multiple myeloma, to offer significantly better treatment efficacy for oncology indications. A clinical trial will be initiated in 2H 2021 in China to evaluate safety and efficacy of combination therapy of lemzoparlimab with felzartamab as a possible novel treatment option for relapsed and refractory and newly diagnosed MM, potentially becoming first-line treatment if proven, in addition to felzartamab currently being evaluated as a second-line and third-line treatment for MM.



    • Potential upcoming milestones:



      • The on-going clinical trial with lemzoparlimab in combination with pembrolizumab in patients with NSCLC and ovarian cancers in the U.S. is on track to deliver preliminary results by Q4 2021.



      • A new clinical trial of lemzoparlimab in combination with PD-1 therapy in patients with selected solid tumors will be initiated in 2H 2021 in China.



      • An abbreviated phase 2 combination study of lemzoparlimab with AZA in untreated AML and MDS patients is planned to commence in Q2 2021 in China. Patient enrollment is expected to complete by Q4 2021.



      • Topline results from the on-going NHL clinical study, involving both the U.S. and China clinical sites, are expected by Q4 2021.



      • The combination study of lemzoparlimab with felzartamab in patients with MM is planned to start in 2H 2021 in China.

    • Uliledlimab (TJD5): A highly differentiated CD73 antibody for immuno-oncology through modulation of tumor microenvironment. Uliledlimab is shown to strongly suppress tumor growth especially when combined with a PD-(L)1 inhibitor in pre-clinical studies. I-Mab has completed a phase 1 clinical trial in the U.S. with positive results for favorable safety, PK/PD, biomarker analysis and clinical activity of uliledlimab. The topline results have been submitted to ASCO 2021.



      • Differentiated mechanism of action by uliledlimab: The Company will present the mechanistic analysis and pre-clinical data at 2021 American Association for Cancer Research (AACR) Annual Meeting. The key differentiation of uliledlimab when compared to other clinical stage antibodies of the same class is related to its novel epitope, which works through a unique intra-dimer binding mode, resulting in a complete inhibition of the enzymatic activity while avoiding the aberrant pharmacological property known as the "hook effect." With this particular mode of action, uliledlimab has the potential to become a best-in-class CD73 antibody for its clinical advantages.



      • Phase 1 clinical trial completed in the U.S.: The initial assessment of a phase 1 clinical study investigating uliledlimab monotherapy lead-in followed by combination with atezolizumab (Tecentriq®), in patients with solid tumors has been completed. Topline results from the study demonstrate that uliledlimab is safe and well tolerated at the dose range evaluated. The study also demonstrated favorable clinical activity of uliledlimab in patients with advanced solid tumors. I-Mab has submitted an abstract to present the topline results at 2021 ASCO annual meeting to be held in June.



      • Continued clinical development: The Company is looking to expand the on-going clinical study of uliledlimab with a PD-1 antibody toripalimab (TUOYI®) in patients with advanced or metastatic cancers in China to further evaluate clinical efficacy of uliledlimab in a phase 2 combination clinical trial with toripalimab in selected solid tumors by a "basket" trial design in 2H 2021.



      • Potential upcoming milestones:



        • I-Mab has submitted an abstract to present the phase 1 topline results at the June 2021 ASCO annual meeting.



        • The expansion study in patients with NSCLC and other selected tumors has been initiated in over 15 sites across China. The results are expected in 2022.

    Core Clinical Assets – Pre-NDA Products

    • Felzartamab (TJ202): A potential highly differentiated CD38 antibody for multiple myeloma (MM) and systemic lupus erythematosus (SLE). Felzartamab is a pre-NDA product in I-Mab's pipeline being positioned to launch in the near-term in China to cover third-line and second-line MM treatment. Its potential role as a first-line MM treatment in combination with lemzoparlimab is being explored.



      • Multiple myeloma: Two registrational studies of felzartamab are on-going. The third-line registrational trial has completed patient enrollment. The Company is on track to submit an NDA in 2H 2021. The second-line combination therapy with lenalidomide is on track and is continuing to enroll patients. Full patient enrollment (N=291) for that trial is expected in Q3 2021. In addition, a new IND for combination trial of felzartamab with lemzoparlimab for MM will be submitted in Q2 2021 and the study will be initiated in 2H 2021 in China. This combination therapy, a possible first-line treatment if proven, has the potential to be a novel treatment option for relapsed and refractory and newly diagnosed MM.
      • SLE: The Company is awaiting IND approval by the NMPA and a phase 1b trial in patients with SLE will be initiated 2H 2021 in China.
      • Potential upcoming milestones:



        • I-Mab expects to submit an NDA for felzartamab as a third-line treatment for MM to the NMPA in Q4 2021.



        • Completion of patient enrollment of the second-line registrational study for MM is anticipated in Q3 2021.



        • In China, a new IND for combination trial of felzartamab with lemzoparlimab as a possible novel treatment option for relapsed and refractory and newly diagnosed MM with the potential to become first-line treatment if proven will be submitted in Q2 2021 and the study will be initiated in 2H 2021.



        • Initiation of phase 1b SLE trial is on track for 2H 2021.
    • Eftansomatropin alfa (TJ101): A differentiated long-acting growth hormone for pediatric growth hormone deficiency (PGHD). Eftansomatropin has a product advantage as it is the only rhGH in its proprietary fusion protein format. Its safety and efficacy have been demonstrated in a phase 2 clinical trial in EU.



      • In February 2021, I-Mab achieved the first patient dosing of a phase 3 registrational clinical trial (NCT04633057) in China to assess the clinical efficacy, safety of eftansomatropin alfa in PGHD patients as a weekly treatment. This registrational phase 3 trial ("TALLER") will enroll 165 patients across multiple centers in China, with the primary objective of demonstrating non-inferiority of 1.2 mg/kg/week of eftansomatropin alfa administered SC, compared to Norditropin, a daily rhGH marketed in China.
      • Potential upcoming milestones:



        • The primary clinical data are expected to be available in Q2 2023 to support the planned NDA submission in China.
    • Efineptakin alfa (TJ107): The world's first long-acting recombinant human interleukin-7. This asset is positioned clinically as a monotherapy for the treatment of cancer patients with lymphopenia and as a combination immunotherapy to pair with PD-1 or PD-L1 antibody for cancer treatment:



      • The on-going phase 1b clinical trial in China is investigating the safety, tolerability and PK/PD profile of efineptakin alfa in patients with advanced solid tumors. The results of the study are expected in Q2 2021.
      • The current clinical development plan is to evaluate the therapeutic role of efineptakin alfa (1) as a monotherapy for cancer patients with lymphopenia and (2) as a combination therapy with PD-1/PD-L1 antibody for cancers. The outcome of the studies will facilitate the development path of efineptakin alfa towards pivotal clinical trials in China.



        • Cancers with lymphopenia. In December 2020, I-Mab initiated a phase 2 randomized, single-blind, placebo-controlled clinical trial (NCT04600817) to evaluate the safety and efficacy of efineptakin alfa in glioblastoma multiforme (GBM) patients with lymphopenia. The primary outcome of the study is the percentage of patients with an increase in the absolute lymphocyte counts and associated clinical response in relation to the treatment with efineptakin alfa.
        • Combination therapy with PD-1/PD-L1 agents. Our partner Genexine recently released encouraging new data of a phase 1b/2 study of efineptakin alfa in combination with pembrolizumab (KEYTRUDA®) for the treatment of relapsed or refractory triple-negative breast cancer (TNBC) in terms of safety and efficacy signals. I-Mab plans to submit an IND in China in 2H 2021 to initiate a phase 2 clinical trial following a basket trial design, in which efineptakin alfa is combined with a PD-1 antibody for the treatment of selected tumor types, including TNBC.

    Other Clinical Assets

    • Plonmarlimab (TJM2): A granulocyte-macrophage colony stimulating factor (GM-CSF) monoclonal antibody for the treatment of rheumatoid arthritis and CRS-related therapies:



      • Cytokine release syndrome associated with severe COVID-19: I-Mab is conducting a phase 2 clinical trial with plonmarlimab for the treatment of cytokine release syndrome associated with severe and critically ill COVID-19 patients (NCT04341116) to potentially save lives of patients with severe COVID-19. The clinical trial has progressed to the second part, aiming to evaluate the efficacy, safety and cytokine levels following a single dose of plonmarlimab at 6 mg/kg or placebo (best supportive care) in patients with severe COVID-19. An interim analysis is planned in Q2 2021.
      • Rheumatoid arthritis: I-Mab has initiated a phase 1b clinical study with plonmarlimab in patients with rheumatoid arthritis (RA). This trial is a multi-center, double-blind, placebo-controlled study involving about 63 patients who will receive a single dose or multiple doses of the treatment for up to eight weeks. The single dose escalation part is aimed to complete by 2H 2021.
    • Olamkicept (TJ301): A potential highly differentiated IL-6 blocker for ulcerative colitis:



      • I-Mab has successfully completed a phase 2 study in 91 patients with active ulcerative colitis (UC) in Greater China and South Korea (NCT03235752) and is at the final stages of data analysis.
      • I-Mab will continue to advance the development and maximize the potential value of this differentiated drug molecule through our global partnership with Ferring.
    • Enoblituzumab: A potential highly differentiated humanized B7-H3 antibody as an immuno-oncology treatment. I-Mab has the development and commercial rights of enoblituzumab in Greater China from MacroGenics.



      • I-Mab plans to submit a pre-IND in Q2 2021 to initiate a phase 2 clinical trial of enoblituzumab in combination with a PD-1 antibody in patients with certain tumors in China. The study is designed as a "basket" clinical trial involving NSCLC and two other selected cancer types based on the previous studies conducted by MacroGenics.
      • I-Mab has plans to evaluate the therapeutic role of enoblituzumab in combination with other targeted cancer therapies as a potential front-line treatment for selected cancers. The pre-clinical work is in progress. Submission of an IND is anticipated by the end of 2021 to start the clinical study.
    • TJ210: A novel monoclonal antibody targeting myeloid derived suppressor cells as a cancer immunotherapy through a novel mechanism of action. This asset is in clinical development through partnership with MorphoSys.



      • Pre-clinical development update: TJ210 is a novel human antibody directed against C5aR1 derived from MorphoSys' HuCAL Platinum® technology. The findings of pre-clinical studies in relation to characterization of unique antibody epitope, pharmacological profile and anti-tumor properties of TJ210 were presented at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting.



      • Current clinical development plan: A phase 1 clinical trial is now enrolling patients in the U.S. to evaluate the safety, tolerability and PK/PD profiles of TJ210 in cancer patients. The program is expected to further evolve into a combination clinical trial with a PD-1 antibody in selected cancer types. In addition, with the IND approved by China's NMPA in February 2021, I-Mab expects to commence a phase 1b clinical trial in 2H 2021. The results of the clinical studies in the U.S. and China, in relation to safety, PK/PD profiles, biomarker analysis and early efficacy signals, as described above will facilitate the further clinical development of TJ210.

    Two new bi-specific antibodies have entered the clinical development stage in 2021

    • TJ-CD4B: A novel bi-specific antibody with the Claudin 18.2 arm as a specific tumor-engager and the 4-1BB arm as a conditional T cell activator upon tumor engagement.



      • TJ-CD4B is a novel and tumor-dependent bi-specific antibody for the treatment of gastric and other cancers which is being developed under collaboration with ABL Bio. Our pre-clinical studies have demonstrated that TJ-CD4B is capable of binding to tumor cells expressing Claudin 18.2, i.e., gastric cancer and pancreatic cancer cells, and stimulating intra-tumoral T cells by the 4-1BB arm designed to be activated only upon tumor engagement whilst silent elsewhere. Thus, TJ-CD4B effectively maintains a strong tumor binding property and anti-tumor activity attributable to a synergistic effect of both Claudin 18.2 antibody and 4-1BB antibody while it avoids or minimizes liver toxicity and systemic immunotoxicity commonly seen with 4-1BB antibodies as a drug class. I-Mab received the IND approval by the U.S. FDA on March 27, 2021 and aims to commence a phase 1 clinical trial in Q2 2021 in patients with advanced solid tumors including gastric cancer to assess the safety, tolerability, PK/PD and preliminary treatment efficacy. In addition, I-Mab will submit a separate IND with the China NMPA in 2H 2021 by leveraging the clinical data generated from the U.S. study to commence parallel clinical development in China.
    • TJ-L14B: A differentiated bi-specific antibody with the PD-L1 arm as a tumor-site T cell activator and the 4-1BB arm as a conditional T cell activator upon tumor engagement.



      • Being developed jointly with ABL Bio, TJ-L14B is a differentiated PD-L1-based bi-specific antibody with the PD-L1 arm as the tumor-dependent T-cell activator and the 4-1BB arm as the conditional T cell activator upon tumor engagement. Pre-clinical tumor animal model studies of TJ-L14B have demonstrated a superior anti-tumor effect attributable to mechanistic synergism of the two antibody arms in activating intra-tumoral T cells. The 4-1BB arm utilizes the same bi-specific antibody format aimed to minimize systemic toxicity as a class effect. With the approved IND from the U.S. FDA, a phase 1 dose escalation clinical study is about to be initiated to assess the safety, tolerability, PK/PD and preliminary efficacy in patients with advanced (unresectable) or metastatic solid tumors.

    Pre-Clinical Assets

    • A number of novel molecules are currently under pre-clinical development, such as: (1) TJX7, a novel monoclonal antibody directed against CXCL13 for the treatment of autoimmune diseases. I-Mab has recently concluded a pre-IND meeting with the U.S. FDA. (2) TJ-C4GM is a fortified CD47 antibody with GM-CSF attached. This antibody-cytokine fusion is designed to enhance the anti-tumor effect of CD47 antibody for solid tumors by activating and converting pro-tumor M2 macrophages to anti-tumor M1 macrophages through the GM-CSF arm. The results of the pre-clinical studies support the novel mechanism of action. (3) TJ-L1I7 is another antibody-cytokine fusion protein with the anti-PDL1 antibody fused with IL-7, which is designed to increase both the number and functionality of T cells drawn to the tumor thereby turning "cold" tumor to more immune-responsive "hot" tumor. (4) TJ-L1C4 belongs to I-Mab's PD-L1 based bi-specific antibody family and uses CD47 antibody as the other arm. The candidate molecule is being developed at an early pre-clinical stage.

    Commercialization Capability

    • In August 2020, I-Mab appointed Mr. Ivan Yifei Zhu as Chief Commercial Officer, a high-caliber commercial leader in China, to prepare for the market launch of its initial series of products in China.
    • Our commercialization strategy is designed to build a leading hematologic oncology franchise in China through I-Mab's unique product portfolio that includes felzartamab (TJ202) for multiple myeloma, lemzoparlimab (TJC4) for various leukemia indications and a late-stage asset/product to be in-licensed to cover lymphoma indications. This unique portfolio of the three key products enables I-Mab to have a near-complete coverage of major disease indications within the hematologic therapeutic area in China and offers an advantageous position to explore a near-cure therapeutic goal for certain hematologic oncology indications through additional drug combinations.
    • Towards building a leading hematologic oncology franchise in China, I-Mab is laying foundations and progressing efficiently towards becoming an integrated commercial organization, encompassing market access, medical marketing, supply chain and sales teams. The initial effort of the sales organization is to focus on the launch readiness of felzartamab, the Company's first hematologic oncology product, by targeting top academic centers and hospital networks across China where the target patient population accounting for majority of national cases is concentrated.

    Manufacturing Facility

    • I-Mab has made significant progress in building a comprehensive biologics manufacturing facility in Hangzhou, China (the "Hangzhou Facility").
    • The Hangzhou Facility aims to have a pilot plant capacity of 2 production lines (1 line configured with 2 x 2,000L and another line with 1 x 2,000L) by 2022 and commercially progressive capacity up to 8 x 4,000L to become operational by the end of 2023.
    • The Hangzhou Facility, when operational, will exclusively serve I-Mab's increasing CMC and manufacturing needs for all on-going and future clinical trials in the U.S. and China and the sustained production of its planned commercial products. The Hangzhou Facility will enable the Company to control the quality and manufacturing schedules tailored to its development and commercialization needs. Importantly, it will significantly reduce our production cost burden and cost of goods as a whole.

    Corporate Achievements

    • In March 2021, I-Mab reported substantial net revenues of RMB 1,542.7 million (US $236.4 million) and net income on a GAAP basis of RMB 470.9 million (US $72.2 million) for the full year of 2020, achieving corporate profitability for the first time in the Company's history.
    • In March 2021, I-Mab secured collaborations with Complix, an EU-based biotech company, and Affinity, a Shanghai-based biotech company, gaining access to cutting edge technology platforms to develop its next generation of novel and highly differentiated drug candidates.
    • In December 2020, I-Mab's American Depositary Shares (ADS) were selected for inclusion in the NASDAQ Biotechnology Index (Nasdaq: .NBI), based on a set of eligibility criteria including minimum market capitalization and average daily trading volume.
    • In December 2020, I-Mab appointed leading Immunology and Hematology experts Dr. Chen Dong and Dr. Jun Ma to its Scientific Advisory Board.
    • In November 2020, I-Mab received BioCentury-Bay Helix's "Deal of the Year" award for the global strategic collaboration with AbbVie to develop and commercialize lemzoparlimab. I-Mab was also named "10 Biotechs to Know in China" by FiercePharma and listed as "50 Smartest Companies in China" by MIT Technology Review.
    • In September 2020, I-Mab raised approximately US$418 million through a private placement by a consortium of institutional investors led by Hillhouse Capital.
    • In September 2020, I-Mab and AbbVie entered into a strategic global collaboration to develop and commercialize lemzoparlimab (TJC4). The total upfront plus milestone payments as well as the potential value of the right of first negotiation in relation to the two additional CD47-based bi-specific antibodies amounted to US $2.94 billion, making this deal the largest cross-border out-licensing transaction from China by total value.
    • In May 2020, I-Mab opened its Hong Kong office as a regional hub for capital markets and investor relations activities, further benefiting from the Greater Bay Area economic development initiative in the region.

    Full Year 2020 Financial Results

    Cash Position

    As of December 31, 2020, the Company had cash, cash equivalents, restricted cash and short-term investments of RMB 4.8 billion (US $734.1 million), compared with RMB 1.2 billion as of December 31, 2019. The current cash on hand is sufficient to fund operations through 2023, including data readouts on core clinical assets such as lemzoparlimab and uliledlimab and commercialization in China of pre-NDA assets felzartamab and efineptakin alfa.

    Net Revenues

    Total net revenues for the full year of 2020 were RMB 1,542.7 million (US $236.4 million), compared with RMB 30.0 million for the full year of 2019. The revenues generated for the full year of 2020 solely consisted of the revenues recognized in connection with the strategic collaboration with AbbVie.

    Research & Development Expenses

    Research and development expenses for the full year of 2020 were RMB 984.7 million (US $150.9 million), compared with RMB 840.4 million for the full year of 2019. The increase was primarily due to the increase in employee benefit expenses, which consist of share-based compensation and payroll expenses, to support expansion of research and development programs.

    Administrative Expenses

    Administrative expenses for the full year of 2020 were RMB 402.4 million (US $61.7 million), compared with RMB 654.6 million for the full year of 2019. The decrease was primarily due to reduced share-based compensation expenses of RMB 305.7 million (US $46.9 million).

    Other Income (Expenses), net

    Net other income for the full year of 2020 was RMB 412.9 million (US $63.3 million), compared with net other expenses of RMB 20.2 million for the full year of 2019. The change was primarily attributable to the RMB 407.6 million gain recognized as a result of the transfer of equity of I-Mab Hangzhou from I-Mab Hong Kong to a group of domestic investors in China. The equity transfer realized the fair value appreciation in the pipeline assets as well as the employment of a team of designated management and workforce.

    Net Income

    Net income for the full year of 2020 was RMB 470.9 million (US $72.2 million), compared with a loss of RMB 1,452.0 million for the full year of 2019. Net income per share attributable to ordinary shareholders for the full year of 2020 was RMB 3.51 (US $0.54), compared with net loss per share attributable to ordinary shareholders of RMB 201.19 for the full year of 2019. Net income per ADS attributable to ordinary shareholders for the full year of 2020 was RMB 8.07 (US $1.24), compared with net loss per ADS attributable to ordinary shareholders of RMB 462.74 for the full year of 2019.

    Non-GAAP Net Income

    Non-GAAP adjusted net income, which excludes share-based compensation expenses, for the full year of 2020 was RMB 997.1 million (US $152.8 million), compared with non-GAAP adjusted net loss of RMB 936.7 million for the full year of 2019. Non-GAAP adjusted net income per share attributable to ordinary shareholders for 2020 was RMB 7.43 (US $1.14), compared with non-GAAP adjusted net loss per share attributable to ordinary shareholders of RMB 131.39 for the full year of 2019. Non-GAAP adjusted net income per ADS attributable to ordinary shareholders for the full year of 2020 was RMB 17.09 (US $2.62), compared with non-GAAP adjusted net loss per ADS attributable to ordinary shareholders of RMB 302.20 for the full year of 2019.

    Conference Call and Webcast Information

    The Company will host a live conference call and webcast on March 29, 2020 at 8:00 a.m. ET. Participants must register in advance of the conference call. Details are as follows:

    Registration Link:http://apac.directeventreg.com/registration/event/4848159
      
    Conference ID:4848159

    Upon registering, each participant will receive a dial-in number, Direct Event passcode, and a unique access PIN, which can be used to join the conference call.

    A webcast replay will be archived on the Company's website for one year after the conclusion of the call at http://ir.i-mabbiopharma.com.

    A telephone replay will be available approximately two hours after the conclusion of the call. To access the replay, please call +1-855-452-5696 (U.S.), +61-2-8199-0299 (International), 400-632-2162 (Mainland China), or 800-963-117 (Hong Kong). The conference ID number for the replay is 4848159.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is an innovation-driven global biotech company focusing on discovery, development and near-term commercialization of novel or highly differentiated biologics in in immuno-oncology therapeutic area. The Company's mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company's unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capabilities. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn, Twitter and WeChat.

    Use of Non-GAAP Financial Measures

    To supplement its consolidated financial statements which are presented in accordance with U.S. GAAP, the Company uses adjusted net income (loss) as a non-GAAP financial measure. Adjusted net income (loss) represents net income (loss) before share-based compensation. The Company's management believes that adjusted net income (loss) facilitates better understanding of operating results and provide management with a better capability to plan and forecast future periods. For more information on the non-GAAP financial measures, please see the table captioned "Reconciliation of GAAP and Non-GAAP Results" set forth at the end of this press release.

    Non-GAAP information is not prepared in accordance with GAAP and may be different from non-GAAP methods of accounting and reporting used by other companies. The presentation of this additional information should not be considered a substitute for GAAP results. A limitation of using adjusted net income (loss) is that adjusted net income (loss) excludes share-based compensation expense that has been and may continue to be incurred in the future.

    Exchange Rate Information

    This announcement contains translations of certain RMB amounts into U.S. dollars at a specified rate solely for the convenience of the reader. Unless otherwise noted, all translations from Renminbi to U.S. dollars are made at a rate of RMB6.5250 to US$1.00, the rate in effect as of December 31, 2020 published by the Federal Reserve Board.

    Safe Harbor Statement

    This press release contains statements that may constitute "forward-looking" statements pursuant to the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "aims," "future," "intends," "plans," "believes," "estimates," "likely to" and similar statements. Statements that are not historical facts, including statements about I-Mab's beliefs, plans and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. Further information regarding these and other risks is included in I-Mab's filings with the SEC. All information provided in this press release is as of the date of this press release, and I-Mab does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail:  

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail: 

    Office line: +86 21 6057 5785

    Investor Inquiries:

    The Piacente Group, Inc.

    Emilie Wu

    E-mail:  

    Office line: + 86 21 6039 8363

    I-MAB

    Consolidated Balance Sheets

    (All amounts in thousands, except for share and per share data, unless otherwise noted)

     As of December 31,
     2019 2020
     RMB RMB US$
          
          
    Assets   
    Current assets     
    Cash and cash equivalents1,137,473 4,758,778 729,315
    Restricted cash55,810 - -
    Accounts receivable- 130,498 20,000
    Contract assets- 227,391 34,849
    Short-term investments32,000 31,530 4,832
    Prepayments and other receivables136,036 195,467 29,957
    Total current assets1,361,319 5,343,664 818,953
    Property, equipment and software30,069 25,272 3,873
    Operating lease right-of-use assets16,435 14,997 2,298
    Intangible assets148,844 120,444 18,459
    Goodwill162,574 162,574 24,916
    Investment accounted for using the equity method- 664,832 101,890
    Other non-current assets18,331 2,010 308
    Total assets1,737,572 6,333,793 970,697
          
    Liabilities, mezzanine equity and shareholders' equity (deficit)     
    Current liabilities     
    Short-term borrowings50,000 - -
    Accruals and other payables273,553 560,558 85,909
    Operating lease liabilities, current6,807 8,058 1,235
    Ordinary shares to be issued to Everest258,119 - -
    Deferred subsidy income- 7,509 1,151
    Total current liabilities588,479 576,125 88,295
    Convertible promissory notes68,199 - -
    Put right liabilities- 116,006 17,779
    Operating lease liabilities, non-current7,492 5,542 849
    Deferred subsidy income3,920 - -
    Other non-current liabilities- 8,975 1,375
    Total liabilities668,090 706,648 108,298
          
    Mezzanine equity     
    Series A convertible preferred shares (US$0.0001 par value, 30,227,056 shares authorized, issued and outstanding as of December 31, 2019, and nil authorized, issued and outstanding as of December 31, 2020)687,482 - -
    Series B convertible preferred shares (US$0.0001 par value, 30,305,212 shares authorized, issued and outstanding as of December 31, 2019, and nil authorized, issued and outstanding as of December 31, 2020)921,243 - -
    Series C convertible preferred shares (US$0.0001 par value, 31,046,360 shares authorized, issued and outstanding as of December 31, 2019, and nil authorized, issued and outstanding as of December 31, 2020)1,306,633 - -
    Series C-1 convertible preferred shares (US$0.0001 par value, 3,857,143 shares authorized, issued and outstanding as of December 31, 2019, and nil authorized, issued and outstanding as of December 31, 2020)188,819 - -
    Total mezzanine equity3,104,177 - -
          



    I-MAB

    Consolidated Balance Sheets (Continued)

    (All amounts in thousands, except for share and per share data, unless otherwise noted)

     As of December 31,

     
     2019 2020 
     RMB RMB US$ 
           
           
    Shareholders' equity (deficit)      
    Ordinary shares (US$0.0001 par value, 500,000,000 and 800,000,000 shares authorized as of December 31, 2019 and December 31, 2020, respectively; 8,363,719 and 164,888,519 shares issued and outstanding as of December 31, 2019 and December 31, 2020, respectively)6 114 17 
    Additional paid-in capital389,379 7,701,116 1,180,249 
    Accumulated other comprehensive income (loss)70,127 (50,793)(7,784)
    Accumulated deficit(2,494,207)(2,023,292)(310,083)
    Total shareholders' equity (deficit)(2,034,695 )5,627,145 862,399 
    Total liabilities, mezzanine equity and shareholders' equity (deficit)1,737,572 6,333,793 970,697 
           



    I-MAB

    Consolidated Statements of Comprehensive Income (Loss)

    (All amounts in thousands, except for share and per share data, unless otherwise noted)

     Year Ended December 31,
     2018  2019  2020 
     RMB  RMB  RMB  US$  
                
    Revenues           
    Licensing and collaboration revenue53,781  30,000  1,542,668  236,424 
    Expenses           
    Research and development expenses (Note 1)(426,028) (840,415) (984,689) (150,910)
    Administrative expenses (Note 2)(66,391) (654,553) (402,409) (61,672)
    Income (loss) from operations(438,638) (1,464,968) 155,570  23,842 
    Interest income4,597  30,570  24,228  3,713 
    Interest expense(11,695) (2,991) (957) (147)
    Other income (expenses), net(16,780) (20,205) 412,892  63,278 
    Equity in loss of an affiliate (Note 3)-  -  (108,587) (16,642)
    Fair value change of warrants61,405  5,644  -  - 
    Income (loss) before income tax expense(401,111) (1,451,950) 483,146  74,044 
    Income tax expense(1,722) -  (12,231) (1,874)
    Net income (loss) attributable to I-MAB(402,833) (1,451,950) 470,915  72,170 
    Deemed dividend to Series C-1 preferred shareholders at extinguishment of Series C-1 Preferred Shares-  (5,283) -  - 
    Deemed dividend to Series B-1, B-2 and C preferred shareholders at modification of Series B-1, B-2 and C Preferred Shares-  (27,768) -  - 
    Net income (loss) attributable to ordinary shareholders(402,833) (1,485,001) 470,915  72,170 
            
            
    Net income (loss) attributable to I-MAB(402,833) (1,451,950) 470,915  72,170 
    Other comprehensive income (loss):       
    Foreign currency translation adjustments, net of nil tax53,689  10,747  (120,920) (18,531)
    Total comprehensive income (loss) attributable to I-MAB(349,144) (1,441,203) 349,995  53,639 
                



    I-MAB

    Consolidated Statements of Comprehensive Income (Loss) (Continued)

    (All amounts in thousands, except for share and per share data, unless otherwise noted)

     Year Ended December 31,
     2018  2019  2020
     RMB  RMB  RMB US$
              
    Net income (loss) attributable to ordinary shareholders(402,833) (1,485,001) 470,915 72,170
    Weighted-average number of ordinary shares used in calculating net income (loss) per share - basic6,529,092  7,381,230  134,158,824 134,158,824
    Weighted-average number of ordinary shares used in calculating net income (loss) per share - diluted6,529,092  7,381,230  157,231,652 157,231,652
              
    Net income (loss) per share attributable to ordinary shareholders         
    —Basic(61.70) (201.19) 3.51 0.54
    —Diluted(61.70) (201.19) 3.00 0.46
    Net income (loss) per ADS attributable to ordinary shareholders (Note 4)         
    —Basic(141.91) (462.74) 8.07 1.24
    —Diluted(141.91) (462.74) 6.90 1.06

    Note:

    (1) Includes share-based compensation expense of RMB470 thousand and RMB284,431 thousand (US$43,591 thousand) for the year ended December 31, 2019 and 2020, respectively.

    (2) Includes share-based compensation expense of RMB514,733 thousand and RMB209,033 thousand (US$32,036 thousand) for the year ended December 31, 2019 and 2020, respectively.

    (3) Includes share-based compensation expense of nil and RMB32,707 thousand (US$5,013 thousand) for the year ended December 31, 2019 and 2020, respectively.

    (4) Each ten ADSs represents twenty-three ordinary shares.



    I-MAB

    Reconciliation of GAAP and Non-GAAP Results

    (All amounts in thousands, except for share and per share data, unless otherwise noted)

     Year ended December 31,
     2018  2019  2020
     RMB  RMB  RMB US$
              
    GAAP net income (loss) attributable to I-MAB(402,833) (1,451,950) 470,915 72,170
    Add back:         
    Share-based compensation expense3,520  515,203  526,171 80,640
    Non-GAAP adjusted net income (loss) attributable to I-MAB(399,313) (936,747) 997,086 152,810
            
    Non-GAAP adjusted income (loss) attributable to ordinary shareholders (399,313) (969,798) 997,086 152,810
    Weighted-average number of ordinary shares used in calculating net income (loss) per share - basic6,529,092  7,381,230  134,158,824 134,158,824
    Weighted-average number of ordinary shares used in calculating net income (loss) per share - diluted6,529,092  7,381,230  157,231,652 157,231,652
    Non-GAAP adjusted income (loss) per share attributable to ordinary shareholders         
    —Basic(61.16) (131.39) 7.43 1.14
    —Diluted(61.16) (131.39) 6.34 0.97
    Non-GAAP adjusted income (loss) per ADS attributable to ordinary shareholders       
    —Basic(140.67) (302.20) 17.09 2.62
    —Diluted(140.67) (302.20) 14.58 2.23

     



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  5. Mandarin session on April 7, 2021 and English session on April 26, 2021 for investors and research analysts

    SHANGHAI, China and GAITHERSBURG, Md., March 24, 2021 (GLOBE NEWSWIRE) -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that it will host its 2021 R&D Day Mandarin session at 14:00 CST on April 7, 2021, and English session on April 26, 2021.

    I-Mab's R&D Day will include presentations from Dr. Jingwu Zang, Founder and Chairman; Dr. Joan Shen, Chief Executive Officer; Mr. Jielun Zhu, Chief Financial Officer; Mr. Yifei Zhu, Chief Commercial Officer, and key opinion leaders. The Company aims to provide an…

    Mandarin session on April 7, 2021 and English session on April 26, 2021 for investors and research analysts

    SHANGHAI, China and GAITHERSBURG, Md., March 24, 2021 (GLOBE NEWSWIRE) -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that it will host its 2021 R&D Day Mandarin session at 14:00 CST on April 7, 2021, and English session on April 26, 2021.

    I-Mab's R&D Day will include presentations from Dr. Jingwu Zang, Founder and Chairman; Dr. Joan Shen, Chief Executive Officer; Mr. Jielun Zhu, Chief Financial Officer; Mr. Yifei Zhu, Chief Commercial Officer, and key opinion leaders. The Company aims to provide an in-depth presentation of its key pipeline programs, its research and development strategy, as well as a progress update on the Company's transformation into a fully integrated global biopharma company.        

    A live webcast will be available at https://ir.i-mabbiopharma.com. An archived copy of the webcast will be accessible on the Events and Presentations section of the Investor Relations page. Participants are advised to register in advance via links below:

    Mandarin Session
    Date:Wednesday, April 7, 2021
    Time: 14:00 – 17:30 (China Standard Time)
    Registration link:http://ibioclub.mikecrm.com/lhg1tRH
      
    English Session
    Date:Monday, April 26, 2021
    Time: 8:00 am – 11:00 am (Eastern Daylight Time)
    Registration link:http://ibioclub.mikecrm.com/GY5CfSo

    About I-Mab

    I-Mab (NASDAQ:IMAB) is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in immuno-oncology therapeutic area. The Company's mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company's unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedInTwitter and WeChat.

    I-Mab Forward Looking Statements

    This press release includes certain disclosures which contain "forward-looking statements." You can identify forward-looking statements because they contain words such as "anticipate" and "expected." Forward-looking statements are based on I-Mab's current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in filings with the U.S. Securities and Exchange Commission. I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail:  

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail:  

    Office line: +86 21 6057 5785

    Investor Inquiries:

    The Piacente Group, Inc.

    Emilie Wu

    E-mail:  

    Office line: +86 21 6039 8363

     



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  6. SHANGHAI, China and GAITHERSBURG, Md., March 19, 2021 (GLOBE NEWSWIRE) -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today filed a prospectus supplement with the Securities and Exchange Commission (the "SEC") to register 19,050,555 ordinary shares, including ordinary shares represented by American depositary shares ("ADSs") of I-Mab, held by Gaoling Fund, L.P. and YHG Investment, L.P. (collectively "Hillhouse"). Hillhouse acquired these ordinary shares pursuant to a series of subscription agreements dated September 3, 2020 through a private placement (the "PIPE Agreements"). The Company is filing a shelf registration to register…

    SHANGHAI, China and GAITHERSBURG, Md., March 19, 2021 (GLOBE NEWSWIRE) -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today filed a prospectus supplement with the Securities and Exchange Commission (the "SEC") to register 19,050,555 ordinary shares, including ordinary shares represented by American depositary shares ("ADSs") of I-Mab, held by Gaoling Fund, L.P. and YHG Investment, L.P. (collectively "Hillhouse"). Hillhouse acquired these ordinary shares pursuant to a series of subscription agreements dated September 3, 2020 through a private placement (the "PIPE Agreements"). The Company is filing a shelf registration to register the aforementioned ordinary shares, including ordinary shares represented by ADSs, to satisfy contractual registration rights of Hillhouse in the PIPE Agreements. Currently, Hillhouse beneficially owns 22,492,602 ordinary shares of the Company, or 13.3% of the total outstanding ordinary shares.

    Each ten (10) ADSs represent twenty-three (23) of our ordinary shares, par value US$0.0001 per share. This prospectus supplement and the accompanying prospectus are part of a registration statement on Form F-3 (No. 333-252793) that the Company filed with the SEC on February 5, 2021 using a "shelf" registration process.

    This announcement shall not constitute an offer to sell, or a solicitation of an offer to buy, the securities described herein, nor shall there be any offer, solicitation or sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in immuno-oncology therapeutic area. The Company's mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company's unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedInTwitter and WeChat.

    I-Mab Forward Looking Statements

    This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about I-Mab's beliefs and expectations, are forward-looking statements. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement. Further information regarding these and other risks is included in I-Mab's filings with the SEC. All information provided in this press release is as of the date of this press release, and I-Mab does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail: 

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail: 

    Office line: +86 21 6057 5785

    Investor Inquiries:

    The Piacente Group, Inc.

    Emilie Wu

    E-mail: 

    Office line: +86 21 6039 8363



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  7. SHANGHAI, China and GAITHERSBURG, Md., March 11, 2021 (GLOBE NEWSWIRE) -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics, today announced that a poster highlighting the mechanistic differentiation and preclinical research for uliledlimab (also known as TJD5) will be presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting taking place virtually April 10 – 15, 2021.

    Internally discovered by I-Mab, uliledlimab is a novel and highly differentiated antibody that targets the CD73 to modulate adenosine enriched cancer microenvironment. It is uniquely designed to mediate complete…

    SHANGHAI, China and GAITHERSBURG, Md., March 11, 2021 (GLOBE NEWSWIRE) -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics, today announced that a poster highlighting the mechanistic differentiation and preclinical research for uliledlimab (also known as TJD5) will be presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting taking place virtually April 10 – 15, 2021.

    Internally discovered by I-Mab, uliledlimab is a novel and highly differentiated antibody that targets the CD73 to modulate adenosine enriched cancer microenvironment. It is uniquely designed to mediate complete inhibition upon binding to a single CD73 dimer, producing a differentiated mechanism of action to avoid an aberrant relationship of pharmacokinetics and pharmacodynamics so called the "hook effect" commonly seen in many other CD73 antibodies. The poster will present detailed data that highlights unique binding epitopes and structure of uliledlimab that endowed with the complete CD73 enzymatic inhibition as well as preclinical immuno-regulatory and anti-tumor activity in a single agent and in combination with PD-(L)1 antibodies.

    Details of the poster presentation are as follows:

    Title:

    Preclinical characterization of uliledlimab, a differentiated CD73 blocking antibody with a unique intra-dimer binding mechanism for cancer immunotherapy
    Abstract #:1871

    Presenting author:Dr. Zhengyi (Jerry) Wang, Vice President of Discovery, I-Mab

    As previously disclosed, the Company had also submitted an abstract for the results of the phase 1 clinical study investigating uliledlimab monotherapy lead-in followed by combination with atezolizumab (Tecentriq®) in patients with solid tumors to ASCO for its 2021 annual meeting to be held virtually on June 4-8, 2021.

    About Uliledlimab (TJD5)

    Uliledlimab (TJD5) is a differentiated, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine. Adenosine in turn binds to adenosine receptors on relevant immune cells and inhibits anti-tumor immune responses in tumor microenvironment. Uliledlimab is expected to offer clinical benefit by suppressing tumor growth in concert with checkpoint therapies such as PD-1 and PD-(L)1 antibodies. Uliledlimab is effective in anti-tumor activities through a unique intra-dimer binding, leading to differentiated and favorable functional properties as evident in preclinical studies.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in immuno-oncology therapeutic area. The Company's mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company's unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedInTwitter and WeChat.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the uliledlimab (TJD5) preclinical studies. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail: 

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail: 

    Office line: +86 21 6057 5785

    Investor Inquiries:

    The Piacente Group, Inc.

    Emilie Wu

    E-mail: 

    Office line: +86 21 6039 8363 



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  8. HASSELT, Belgium, March 10, 2021 /PRNewswire/ -- Complix, a biopharmaceutical company developing a pipeline of transformative Alphabody therapeutics announces that it has signed a significant drug discovery deal with I-Mab (NASDAQ:IMAB), an innovation-driven clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel and highly differentiated biologics in the immuno-oncology therapeutic area. 

    Under the terms of the agreement, Complix will use its proprietary Alphabody platform to deliver Cell Penetrating Alphabodies (CPABs) against two immuno-oncology intracellular targets. The resulting CPABs will undergo clinical development that will be jointly managed by both companies.

    I-Mab will have…

    HASSELT, Belgium, March 10, 2021 /PRNewswire/ -- Complix, a biopharmaceutical company developing a pipeline of transformative Alphabody therapeutics announces that it has signed a significant drug discovery deal with I-Mab (NASDAQ:IMAB), an innovation-driven clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel and highly differentiated biologics in the immuno-oncology therapeutic area. 

    Under the terms of the agreement, Complix will use its proprietary Alphabody platform to deliver Cell Penetrating Alphabodies (CPABs) against two immuno-oncology intracellular targets. The resulting CPABs will undergo clinical development that will be jointly managed by both companies.

    I-Mab will have an exclusive license to commercialize the CPABs in Greater China, with the rest of the world commercialization rights being equally owned by both companies. In return, Complix is entitled to receive an upfront payment and potential development milestones fees, as well as tiered royalties.

    CPABs are a revolutionary class of small proteins engineered to bind to a variety of antigens. Data available show that CPABs have the potential to address a wide range of disease targets, particularly intracellular targets that are difficult for current therapies to reach.

    In addition to crossing cellular membranes, Alphabodies have the potential to cross the blood brain barrier to address CNS diseases and to be delivered orally given their ability to cross the gut wall.

    Mark Vaeck, CEO of Complix, said: 

    "We are pleased to have signed this important new oncology/immuno-oncology collaboration with I-Mab, based on the unique capabilities of our CPABs to address intractable intracellular targets. We are looking forward to developing novel CPAB drug candidates that have a beneficial therapeutic impact on the two immuno-oncology targets put forward by I-Mab. We are also happy to be working with a partner with the ability and commitment to commercializing these products in Greater China and to have retained a commercial interest in these CPABs in the rest of the world, providing us with an additional opportunity to generate shareholder value."

    Taylor Guo, Chief Scientific Officer of I-Mab said:

    "The partnership with Complix is part of our strategy to create a new cycle of pipeline programs, as our current set of assets advances rapidly towards late-stage clinical development and BLA (Biologics License Application)"). As a company pushing the boundaries on innovation, I-Mab is anchoring its efforts in new medicines that have transformative potential. We have been impressed with the data that Complix has generated to support the unique ability of its CPAB platform to address intracellular targets, and we believe that these CPABs are pioneering the next wave of cancer therapeutics that can potentially address the unmet needs in patient and clinical care."

    About Complix

    Complix is a biopharmaceutical company using its unique AlphabodyTM platform to develop a pipeline of transformative, "membrane crossing" therapeutics against a number of cutting-edge and challenging disease targets that play an important role in oncology, autoimmunity and viral diseases.

    In addition to crossing cellular membranes, Alphabodies have the potential to cross the blood brain barrier to address CNS diseases and to be delivered orally given their ability to cross the gut wall.

    Complix is developing Cell Penetrating Alphabodies (CPABs) that can address disease targets present in the cytosol or in the nucleus of human cells. CPABs act with great specificity and high affinity on targets that are considered "intractable" by current drug formats, such as antibodies or small chemicals. CPABs are also equipped with half-life extension motifs, so that they stay in circulation for sufficient time to ensure optimal biodistribution in peripheral tissues to reach the cells where their target is located. As a pioneer in intracellular targeting, Complix aims to develop a collection of first-in-class therapeutics with the potential to cure severe diseases with high unmet medical need.

    Alphabodies also provide an ideal scaffold to design potent inhibitors of viral entry. Complix believes that its research could yield broadly cross-reactive anti-viral compounds with both prophylactic and therapeutic efficacy against SARS-CoV-2 as well as future emerging coronavirus variants or mutants.

    Complix has established a strong intellectual property position protecting the Alphabody platform and its emerging product portfolio through the filing of multiple patent applications. The company is led by an experienced management team with a track record of success in the biotech industry and is backed by a syndicate of experienced life sciences investors, through which it has raised close to US$ 40 million to date.

    Contacts:

    Complix NV

    Dr. Mark Vaeck, Chief Executive Officer

    +32 9 261 69 40

     www.complix.com

    Cision View original content:http://www.prnewswire.com/news-releases/complix-signs-global-drug-discovery-and-development-agreement-with-i-mab-to-develop-cell-penetrating-alphabodies-against-two-intracellular-immuno-oncology-targets-301244581.html

    SOURCE Complix

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  9. - New Initiative is part of I-Mab's long-term strategy to drive innovation and scientific leadership in immuno-oncology
    - New collaborations signed will allow I-Mab access to cutting edge technology platforms to develop novel drug molecules
    - I-Mab continues to focus on delivering on key clinical programs while building pipeline of next generation assets

    SHANGHAI, China and GAITHERSBURG, MD., March 10, 2021 (GLOBE NEWSWIRE) -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced the signing of two new collaborations that sets in motion a discovery initiative to drive innovation and pipeline growth.

    The collaborations…

    - New Initiative is part of I-Mab's long-term strategy to drive innovation and scientific leadership in immuno-oncology

    - New collaborations signed will allow I-Mab access to cutting edge technology platforms to develop novel drug molecules

    - I-Mab continues to focus on delivering on key clinical programs while building pipeline of next generation assets

    SHANGHAI, China and GAITHERSBURG, MD., March 10, 2021 (GLOBE NEWSWIRE) -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced the signing of two new collaborations that sets in motion a discovery initiative to drive innovation and pipeline growth.

    The collaborations with Complix, an EU-based biotech company, and Affinity, a Shanghai-based biotech company, allow I-Mab access to cutting edge technology platforms to create next generation of novel and highly differentiated drug candidates, including Cell Penetrating Alphabodies (CPAB) for otherwise intractable intracellular drug targets and masked antibodies for targeted tumor-site activation, respectively. These new assets will complement existing clinical programs that continue to be the core focus of the Company. I-Mab has built a successful portfolio of novel and highly differentiated monoclonal and bispecific antibodies that are currently advancing towards late-stage clinical development and biologic license application (BLA).

    "The discovery initiative is part of our long-term strategy to continue to drive innovation and scientific leadership in immuno-oncology," said Dr. Taylor Guo, Chief Scientific Officer, I-Mab. "We remain laser focused on delivering against key clinical milestones as we look to strengthen our pipeline. Collaborations with Complix and Affinity are first of many that will propel the discovery engine to generate the next wave of cancer therapeutics with transformative potential and drive future pipeline growth."

    "We are pleased to have signed this important collaboration with I-Mab. We look forward to sharing our scientific capabilities and expertise in the CPAB platform technology to uncover revolutionary therapeutics that can address intractable targets that have remained undruggable with existing drug formats," said Dr. Mark Vaeck, CEO of Complix.

    "We are excited at the prospect of working together with I-Mab to create a set of novel masked antibodies designed for specific tumor-site activation. This collaboration leverages I-Mab's expertise and existing antibody sequences in immuno-oncology and our proprietary antibody engineering platform to synergize our discovery and development efforts for innovation," said Dr. Cheng Liu, CEO of Affinity.

    Both partner companies will receive undisclosed milestone fees stipulated in the partnership agreements.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in immuno-oncology therapeutic area. The Company's mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company's unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedInTwitter and WeChat.

    About Complix 

    Complix is a biopharmaceutical company using its unique AlphabodyTM platform to develop a pipeline of transformative, "membrane crossing" therapeutics against a number of cutting-edge and challenging disease targets that play an important role in oncology, autoimmunity and viral diseases.  

    In addition to crossing cellular membranes, Alphabodies, have the potential to cross the blood brain barrier to address CNS diseases and to be delivered orally given their ability to cross the gut wall.

    Complix is developing Cell Penetrating Alphabodies (CPABs) that can address disease targets present in the cytosol or in the nucleus of human cells. CPABs act with great precision and high affinity on targets that are considered "intractable" by current drug formats, such as antibodies or small chemicals. As a pioneer in intracellular targeting, Complix aims to develop a collection of first-in-class therapeutics with the potential to cure severe diseases with high unmet medical need.

    Alphabodies also provide an ideal scaffold to design potent inhibitors of viral entry. Complix believes that its research could yield broadly cross-reactive anti-viral compounds with both prophylactic and therapeutic efficacy against SARS-CoV-2 as well as future emerging coronavirus variants or mutants.

    Complix has established a strong intellectual property position protecting the Alphabody platform and its emerging product portfolio through the filing of multiple patent applications. The company is led by an experienced management team with a track record of success in the biotech industry and is backed by a syndicate of experienced life sciences investors, through which it has raised close to US$ 40 million to date. 

    About Affinity

    Shanghai Affinity Biopharmaceutical Co., Ltd. focuses on the development of a Tumor MicroEnvironment Activated (TMEA) platform®. Based on this proprietary TMEA platform®, Affinity focuses on development of TMEA drugs to solve the on-target toxicity of anti-tumor drugs.

    Affinity's TMEA platform® can be broadly applied to therapeutic small molecules, proteins and antibodies, it allows selective unleash of the drug in the tumor microenvironment locally, reduces "on target, off tumor toxicity" and improves therapeutic index.

    I-Mab Forward Looking Statements

    This press release includes certain disclosures which contain "forward-looking statements." You can identify forward-looking statements because they contain words such as "anticipate" and "expected." Forward-looking statements are based on I-Mab's current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in filings with the U.S. Securities and Exchange Commission. I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail: 

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail: 

    Office line: +86 21 6057 5785

    Investor Inquiries:

    The Piacente Group, Inc.

    Emilie Wu

    E-mail: 

    Office line: +86 21 6039 8363



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  10. SHANGHAI and GAITHERSBURG, Md., March 3, 2021 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that it will report financial results for the full year ended December 31, 2020 before the market opens on Monday, March 29, 2021, and host a conference call to discuss the results and provide a corporate update at 8:00 a.m. ET.

    Conference Call and Webcast Information

    I-Mab will host a live conference call and webcast on March 29, 2021 at 8:00 a.m. ET. Participants must register in advance of the conference call. Details are as follows:

    Registration Link:

    http://apac.directeventreg.com/registration/event/4848159

    Conference ID:

    4848159

    Upon registering, each participant will receive a dial-in number, Direct Event passcode, and a unique access PIN, which can be used to join the conference call.

    A webcast replay will be archived on the Company's website for one year after the conclusion of the call at http://ir.i-mabbiopharma.com.

    A telephone replay will be available approximately two hours after the conclusion of the call. To access the replay, please call +1-855-452-5696 (U.S.), +61-2-8199-0299 (International), 400-632-2162 (Mainland China), or 800-963-117 (Hong Kong). The conference ID number for the replay is 4848159.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in immuno-oncology therapeutic area. The Company's mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company's unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedInTwitter and WeChat.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail: 

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail: 

    Office line: +86 21 6057 5785

    Investor Inquiries:

    The Piacente Group, Inc.

    Emilie Wu

    E-mail: epiacentegroup.com

    Office line: +86 21 6039 8363

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/i-mab-to-report-financial-results-for-the-full-year-2020-and-provide-corporate-update-on-march-29-2021-301239583.html

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  11. SHANGHAI and GAITHERSBURG, Md., Feb. 25, 2021 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the first patient has been dosed in the phase 3 pivotal trial (TALLER) for eftansomatropin alfa (also known as TJ101) as a weekly treatment for pediatric growth hormone deficiency (PGHD) in China.

    Eftansomatropin alfa is an innovative long-acting recombinant human growth hormone (rhGH) with a novel molecular format utilizing Genexine's patented half-life extension hyFc® fusion technology. Most rhGHs have to be injected daily, which often hampers patient compliance and can adversely affect the clinical outcomes. Because of its unique features, eftansomatropin alfa may have long-term safety advantages over the conventional pegylated rhGH drugs, and its longer-acting regimen may offer advantages over daily injections. In the previous clinical trials, including a phase 2 study in Europe, eftansomatropin alfa was demonstrated to be safe and well-tolerated, and the clinical efficacy of weekly or biweekly regimens was comparable to that of the daily injected rhGH (genotropin).

    "We look forward to the start of this pivotal trial. A successful result would have significant implications in the quality of life of the patients," said Professor Xiaoping Luo, a national thought leader in PGHD, principal investigator of the study and chairman of the Department of Pediatrics at Wuhan Tongji Hospital.  

    "In China where there are more than 3.4 million children with growth hormone deficiency and only a small percentage of them receiving treatment. I-Mab is well positioned to address this significant unmet need," said Dr. Joan Shen, CEO of I-Mab. "With the initiation of this pivotal trial, we hope to bring a highly differentiated growth hormone replacement therapy to our children." 

    About TALLER

    TALLER is a multi-center, randomized, open-label, active-controlled phase 3 clinical study (NCT04633057) designed to assess the safety, efficacy, and pharmacokinetics (PK) of eftansomatropin alfa in pediatric growth hormone deficiency. The trial will enroll 165 patients between 3 years and 10 years of age across multiple centers in China. Patients will be randomized to receive either eftansomatropin alfa 1.2 mg/kg weekly or the active comparator drug Norditropin® (somatropin) 0.035 mg/kg daily subcutaneous injections for 52 weeks. The primary objective is to demonstrate non-inferiority of eftansomatropin alfa to the active control Norditropin®, a daily rhGH marketed in China.

    About Eftansomatropin alfa

    Eftansomatropin alfa is a potential highly differentiated long-acting recombinant human growth hormone being developed as a more convenient and effective therapy for GHD. Like endogenous growth hormone, eftansomatropin alfa stimulates the production of insulin-like growth factor 1 (IGF-1) in the liver, which has growth-stimulating effects on a variety of tissues, including osteoblast and chondrocyte activities that stimulate bone growth. IGF-1 is a reliable pharmacodynamic marker and the key mediator of growth-promoting activity of eftansomatropin alfa. Eftansomatropin alfa is based on Genexine's patented hyFc® technology. The hyFc part consists of a portion of human immunoglobulin D ("IgD") and G4 ("IgG4"). The former contains a flexible hinge, and the latter is responsible for half-life extension through neonatal Fc receptor ("FcRn")-mediated recycling.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in immuno-oncology therapeutic area. The Company's mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company's unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedInTwitter and WeChat.

    I-Mab Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the eftansomatropin alfa (TJ101) clinical trials, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones and commercialization of eftansomatropin alfa (TJ101). Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail: 

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail: 

    Office line: +86 21 6057 5785

    Investor Inquiries:

    The Piacente Group, Inc.

    Emilie Wu

    E-mail: 

    Office line: +86 21 6039 8363

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/i-mab-announces-first-patient-dosed-in-china-phase-3-study-of-eftansomatropin-alfa-in-pediatric-patients-with-growth-hormone-deficiency-301235443.html

    SOURCE I-Mab

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  12. SHANGHAI and GAITHERSBURG, Md., Feb. 24, 2021 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced its participation in the following conferences in March. Details of the conferences and management presentation are as follows:

    H.C. Wainwright Global Life Sciences Conference (Virtual)

    Presentation: Tuesday, March 9, 2021 at 7:00 a.m. EST

    Presenter: Mr. Jielun Zhu, Director and Chief Financial Officer

    Webcast link: https://journey.ct.events/view/82bf84ac-4e9c-4ebd-baab-b0bf034e93af. The webcast will also be available under "Event Calendar" on IMAB's IR website at http://ir.i-mabbiopharma.com/.

    One-on-one meetings: March 9-10, 2021

    Management participants: Dr. Jingwu Zang, Founder, Honorary Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Ms. Leah Liu, Senior IR Director

    For more information, please contact your H.C. Wainwright representative.

    24th Credit Suisse Asian Investment Conference (Virtual)

    Management participants: Dr. Jingwu Zang, Founder, Honorary Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Ms. Leah Liu, Senior IR Director

    One-on-one and small group meetings: March 22-26, 2021

    For more information, please contact your Credit Suisse representative.

    Morgan Stanley Hong Kong Summit (Virtual)

    Management participants: Dr. Jingwu Zang, Founder, Honorary Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Ms. Leah Liu, Senior IR Director

    One-on-one and small group meetings: March 29-31, 2021

    For more information, please contact your Morgan Stanley representative.

    About I-Mab

    I-Mab (Nasdaq: IMAB) is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in immuno-oncology therapeutic area. The Company's mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company's unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedInTwitter and WeChat.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail:

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail:

    Office line: +86 21 6057 5785

    Investor Inquiries:

    The Piacente Group, Inc.

    Emilie Wu

    E-mail:

    Office line: + 86 21 6039 8363

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/i-mab-announces-upcoming-participation-at-march-conferences-301234360.html

    SOURCE I-Mab

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  13. SHANGHAI and GAITHERSBURG, Md., Feb. 10, 2021 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has cleared the Investigational New Drug (IND) application for TJ210/MOR210 to initiate a phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TJ210/MOR210 monotherapy in patients with advanced solid tumors.

    TJ210/MOR210 is a monoclonal antibody developed by MorphoSys that is directed against complement factor C5a receptor 1 (C5aR1). Produced in the tumoral microenvironment, its ligand C5a acts as a chemoattractant to recruit tumor-promoting cells such as myeloid-derived suppressor cells, M2 macrophages and neutrophils. TJ210/MOR210 is designed to induce anti-tumor properties by blocking the activation and migration of C5aR1-expressing myeloid cells.

    Preclinical studies have shown that targeting the C5aR-C5a axis exerts anti-tumor activity with immune checkpoint inhibitors. Furthermore, in vitro activity was observed for blocking the C5a/C5aR pathway also at very high C5a concentrations, leading to a long duration of action. TJ210/MOR210 demonstrated a good safety profile with no observed adverse effects up to the highest dose tested in non-clinical safety studies.

    The phase 1 clinical trial is an open-label dose escalation study with multiple doses to evaluate the safety, tolerability, and PK/PD and preliminary efficacy of TJ210/MOR210 in subjects with relapsed or refractory advanced solid tumors. I-Mab is also conducting a phase 1 dose escalation clinical trial in patients with r/r advanced solid tumors in the U.S. The first patient in the U.S. study was dosed in January 2021. 

    "We are pleased to obtain the IND clearance for TJ210/MOR210 into clinical trials in China. Now with clinical trials both in the U.S. and China, we expect to accelerate this investigational drug development. The clinical data generated will enable us to further explore TJ210/MOR210's potentials in treating patients with cancers, especially those who failed with or relapsed from the existing therapies," said Dr. Joan Shen, CEO of I-Mab.

    About TJ210/MOR210

    TJ210/MOR210 is a novel human antibody directed against C5aR1 derived from MorphoSys's HuCAL Platinum® technology. C5aR1, the receptor of the complement factor C5a, is investigated as a potential new drug target in the field of immuno-oncology and autoimmune diseases. Tumors have been shown to produce high amounts of C5a, which, by recruiting and activating myeloid-derived suppressor cells (MDSCs), M2 macrophages and neutrophils, is assumed to contribute to an immune-suppressive pro-tumorigenic microenvironment. TJ210/MOR210 is intended to block the interaction between C5a and its receptor, thereby potentially neutralizing the immune suppressive function of C5a and enabling immune cells to attack the tumor.

    HuCAL Platinum® is a registered trademark of MorphoSys AG.

    About I-Mab

    I-Mab (Nasdaq: IMAB) is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in immuno-oncology therapeutic area. The Company's mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company's unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedInTwitter and WeChat.

    I-Mab Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the TJ210/MOR210 phase 1 studies, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones and commercialization of TJ210/MOR210. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its dru g candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail: 

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail: 

    Office line: +86 21 6057 5785

    Investor Inquiries:

    The Piacente Group, Inc.

    Emilie Wu

    E-mail: 

    Office line: +86 21 6039 8363

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/i-mab-announces-china-nmpa-clearance-for-phase-1-study-of-tj210mor210-in-patients-with-advanced-solid-tumors-301225576.html

    SOURCE I-Mab

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  14. SHANGHAI and GAITHERSBURG, Md., Feb. 9, 2021 /PRNewswire/ -- A registered follow-on public offering by certain pre-IPO shareholders (the "Selling Shareholders") of 3,283,950 American depositary shares (the "ADSs" and such offering, the "ADS Offering") of I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, has priced on February 8, 2021 at a public offering price of US$54.0 per ADS. The underwriters in the ADS Offering will have a 30-day option to purchase up to 492,590 additional ADSs from certain Selling Shareholders. Each ten (10) ADSs represent twenty-three (23) ordinary shares of the Company.

    SHANGHAI and GAITHERSBURG, Md., Feb. 9, 2021 /PRNewswire/ -- A registered follow-on public offering by certain pre-IPO shareholders (the "Selling Shareholders") of 3,283,950 American depositary shares (the "ADSs" and such offering, the "ADS Offering") of I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, has priced on February 8, 2021 at a public offering price of US$54.0 per ADS. The underwriters in the ADS Offering will have a 30-day option to purchase up to 492,590 additional ADSs from certain Selling Shareholders. Each ten (10) ADSs represent twenty-three (23) ordinary shares of the Company.

    The Company will not receive any proceeds from the sale of the ADSs by the Selling Shareholders.

    BofA Securities, Inc., Piper Sandler & Co. and Cantor Fitzgerald & Co. act as joint bookrunners for the ADS Offering.

    The ADS Offering is being made only by means of a prospectus supplement and the accompanying prospectus included in an automatic shelf registration statement on Form F-3 filed with the U.S. Securities and Exchange Commission (the "SEC") on February 5, 2021, which automatically became effective upon filing. The registration statement on Form F-3 and the preliminary prospectus supplement dated February 5, 2021 are available at the SEC website at: http://www.sec.gov. The final prospectus supplement will be filed with the SEC and will be available on the SEC's website at: http://www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting BofA Securities, Inc., Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte NC 28255-0001, or by emailing ; Piper Sandler & Co., Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone: (800) 747-3924, or by email: ; and Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 499 Park Avenue, 6th Floor, New York, New York, 10022 or by email at .

    This announcement shall not constitute an offer to sell, or a solicitation of an offer to buy, the securities described herein, nor shall there be any offer, solicitation or sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About I-Mab

    I-Mab (Nasdaq: IMAB) is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in immuno-oncology therapeutic area. The Company's mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company's unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn, Twitter and WeChat.

    Forward Looking Statements

    This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about I-Mab's beliefs and expectations, are forward-looking statements. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement. Further information regarding these and other risks is included in I-Mab's filings with the SEC. All information provided in this press release is as of the date of this press release, and I-Mab does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail: 

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail: 

    Office line: +86 21 6057 5785

    Investor Inquiries:

    The Piacente Group, Inc.

    Emilie Wu

    E-mail: 

    Office line: +86 21 6039 8363

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/registered-secondary-public-offering-of-american-depositary-shares-by-certain-pre-ipo-shareholders-of-i-mab-has-priced-301224717.html

    SOURCE I-Mab

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  15. SHANGHAI and GAITHERSBURG, Md., Feb. 5, 2021 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced the commencement of a proposed registered underwritten public offering by certain pre-IPO shareholders (the "Selling Shareholders") of American depositary shares (the "ADSs"), each ten (10) ADSs representing twenty-three (23) ordinary shares of the Company. The Selling Shareholders propose to offer an aggregate of 3,283,950 ADSs (the "ADS Offering"). The Selling Shareholders will also grant the underwriters a 30-day option to purchase up to 492,590 additional ADSs.

    SHANGHAI and GAITHERSBURG, Md., Feb. 5, 2021 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced the commencement of a proposed registered underwritten public offering by certain pre-IPO shareholders (the "Selling Shareholders") of American depositary shares (the "ADSs"), each ten (10) ADSs representing twenty-three (23) ordinary shares of the Company. The Selling Shareholders propose to offer an aggregate of 3,283,950 ADSs (the "ADS Offering"). The Selling Shareholders will also grant the underwriters a 30-day option to purchase up to 492,590 additional ADSs.

    The Company will not receive any proceeds from the sale of the ADSs by the Selling Shareholders.

    BofA Securities, Inc., Piper Sandler & Co. and Cantor Fitzgerald & Co. act as joint bookrunners for the ADS Offering.

    The ADS Offering is being made only by means of a prospectus supplement and the accompanying prospectus included in an automatic shelf registration statement on Form F-3 filed with the U.S. Securities and Exchange Commission (the "SEC") on February 5, 2021, which automatically became effective upon filing. The registration statement on Form F-3 and the preliminary prospectus supplement dated February 5, 2021 are available on the SEC website at: http://www.sec.gov. The final prospectus supplement will be filed with the SEC and will be available on the SEC's website at: http://www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting BofA Securities, Inc., Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte NC 28255-0001, or by emailing ; Piper Sandler & Co., Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone: (800) 747-3924, or by email: ; and Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 499 Park Avenue, 6th Floor, New York, New York, 10022 or by email at .

    This announcement shall not constitute an offer to sell, or a solicitation of an offer to buy, the securities described herein, nor shall there be any offer, solicitation or sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About I-Mab

    I-Mab (Nasdaq: IMAB) is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in immuno-oncology therapeutic area. The Company's mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company's unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn, Twitter and WeChat.

    Forward Looking Statements

    This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about I-Mab's beliefs and expectations, are forward-looking statements. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement. Further information regarding these and other risks is included in I-Mab's filings with the SEC. All information provided in this press release is as of the date of this press release, and I-Mab does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, CFO

    E-mail: 


    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communication Officer

    E-mail: 


    Office line: +86 21 6057 5785

    Investor Inquiries:

    The Piacente Group, Inc.

    Emilie Wu

    E-mail: 


    Office line: +86 21 6039 8363

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/proposed-registered-secondary-public-offering-of-american-depositary-shares-by-certain-pre-ipo-shareholders-of-i-mab-301223339.html

    SOURCE I-Mab

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  16. SHANGHAI and GAITHERSBURG, Md., Feb. 5, 2021 /PRNewswire/ -- I-Mab (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics, today announced multiple clinical advancements for its proprietary and highly differentiated CD73 antibody, uliledlimab (also known as TJD5, or TJ004309) in advanced solid tumors. The Company plans to present detailed clinical results at select scientific conferences this year.

    I-MAB Logo (PRNewsfoto/I-Mab Biopharma)

    CD73 is implicated in tumor resistance to checkpoint immunotherapies as it plays a critical role in adenosine-mediated immune suppression in tumor microenvironment. Uliledlimab is a humanized CD73 antibody and works effectively on modulating…

    SHANGHAI and GAITHERSBURG, Md., Feb. 5, 2021 /PRNewswire/ -- I-Mab (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics, today announced multiple clinical advancements for its proprietary and highly differentiated CD73 antibody, uliledlimab (also known as TJD5, or TJ004309) in advanced solid tumors. The Company plans to present detailed clinical results at select scientific conferences this year.

    I-MAB Logo (PRNewsfoto/I-Mab Biopharma)

    CD73 is implicated in tumor resistance to checkpoint immunotherapies as it plays a critical role in adenosine-mediated immune suppression in tumor microenvironment. Uliledlimab is a humanized CD73 antibody and works effectively on modulating tumor microenvironment through inhibition of the adenosine pathway. Uliledlimab is shown to strongly suppress tumor growth especially when combined with a PD-(L)1 inhibitor in pre-clinical studies. As a differentiated CD73 antibody, uliledlimab interacts with a unique epitope to function through a novel intra-dimer binding mode, thus enabling differentiated and favorable functional properties. Detailed data from the pre-clinical and mechanistic studies have been submitted for presentation at the upcoming American Association of Cancer Research Annual Meeting.     

    I-Mab has made significant progress in the global clinical development of uliledlimab. In China, I-Mab is advancing the phase 1/2 dose escalation and cohort expansion study of uliledlimab as a single agent and in combination with toripalimab (TUOYI®) in patients with advanced or metastatic cancers who are refractory to or intolerant of available therapies. On February 3, 2021, the first patient in the combination study was dosed.

    In the U.S., I-Mab has completed the initial assessment of its clinical study investigating uliledlimab monotherapy lead-in followed by combination with atezolizumab (Tecentriq®) in patients with solid tumors. Topline results from a clinical study under contract with TRACON show that uliledlimab is safe and well tolerated at the dose range evaluated and demonstrate clinical activity in patients with advanced solid tumors. The Company is scheduled to submit an abstract to ASCO for the 2021 annual meeting.

    "We are encouraged and very pleased by the clinical results and overall advancements of uliledlimab in both China and the U.S.," said Dr. Joan Shen, CEO of I-Mab. "We believe that the combination of uliledlimab with immune checkpoint inhibitors, such as toripalimab or atezolizumab, has the potential to offer a novel treatment option with intended clinical benefit in cancer patients who do not or poorly respond to current checkpoint immunotherapies."

    About Uliledlimab (TJD5)

    Uliledlimab (TJD5) is a differentiated, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine.  Adenosine in turn binds to adenosine receptors on relevant immune cells and inhibits anti-tumor immune responses in tumor microenvironment.  Uliledlimab is expected to offer clinical benefit by suppressing tumor growth in concert with checkpoint therapies such as PD-1 and PD-(L)1 antibodies. Uliledlimab is effective in anti-tumor activities through a unique intra-dimer binding, leading to differentiated and favorable functional properties as evident in preclinical studies.

    About I-Mab

    I-Mab (Nasdaq: IMAB) is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in  immuno-oncology therapeutic area. The Company's mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company's unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn, Twitter and WeChat.

    I-Mab Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the TJD5 phase 1 trial, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones and commercialization of TJD5. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail:

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail:

    Office line: +86 21 6057 5785

    Investor Inquiries:

    The Piacente Group, Inc.

    Emilie Wu

    E-mail:

    Office line: + 86 21 6039 8363

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/i-mab-announces-multiple-clinical-advancements-of-its-differentiated-cd73-antibody-uliledlimab-in-china-and-the-us-301223033.html

    SOURCE I-Mab

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  17. SHANGHAI and GAITHERSBURG, Md., Feb. 4, 2021 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the first patient has been dosed in a phase 2 clinical trial (NCT04600817) of TJ107 (efineptakin alpha), a novel long-acting recombinant human interleukin-7 (rhIL-7),  in patients with glioblastoma multiforme (GBM) in China.

    I-MAB Logo (PRNewsfoto/I-Mab Biopharma)

    The phase 2 trial is a randomized, single-blind, placebo-controlled study to evaluate the efficacy and safety of TJ107 in lymphopenic patients with newly diagnosed GBM who have been treated with standard concurrent chemoradiotherapy. The study's goal is to determine the proportion…

    SHANGHAI and GAITHERSBURG, Md., Feb. 4, 2021 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the first patient has been dosed in a phase 2 clinical trial (NCT04600817) of TJ107 (efineptakin alpha), a novel long-acting recombinant human interleukin-7 (rhIL-7),  in patients with glioblastoma multiforme (GBM) in China.

    I-MAB Logo (PRNewsfoto/I-Mab Biopharma)

    The phase 2 trial is a randomized, single-blind, placebo-controlled study to evaluate the efficacy and safety of TJ107 in lymphopenic patients with newly diagnosed GBM who have been treated with standard concurrent chemoradiotherapy. The study's goal is to determine the proportion of patients with an increase in the absolute lymphocyte counts and associated clinical response after the administration of the first TJ107 dose.

    There is increasing evidence that lymphopenia induced by radiotherapy and chemotherapy is associated with poor survival in cancer patients. In case of GBM, standard treatments induce long-lasting lymphopenia in most patients, and currently there are no definitive therapies for it. A phase 1b study conducted by Genexine Inc. (KOSDAQ: 095700) demonstrated that TJ107 rapidly increased absolute lymphocyte counts and restored T cell counts especially in the naïve and memory subsets but not the regulatory T cells in terminally ill patients with solid tumors. TJ107 was well tolerated with no dose-limiting toxicity or cytokine release syndrome observed.

    "Despite advances in standard therapy, GBM is associated with poor clinical outcomes and survival rates," said Professor Wenbin Li, Director of Department of Neuro-Oncology at Beijing Tiantan Hospital of Capital Medical University and the leading principal investigator of the clinical trial. "Based on its preclinical and clinical data, TJ107 promises to improve tolerance to the standard therapy, quality of life and prognosis in patients with GBM, and we look forward to making this drug accessible to our patients."

    "TJ107 is the first and only long-acting rhIL-7 in the clinical stage globally and early studies have shown its potential to treat patients with GBM whose prognosis is still poor," said Dr. Joan Shen, Chief Executive Officer of I-Mab. "The initiation of the phase 2 trial brings us one step closer to delivering a highly innovative therapy to treat patients with one of the most life-threatening forms of cancer."

    GBM is the most aggressive type of glial cancer which can arise in the brain de novo or evolve from existing tumors. GBM accounts for 17% of new brain and nervous system cancers in China, according to data from the World Health Organization in 2018.[1]

    [1] Ostrom Q T, Gittleman H, Liao P, et al. CBTRUS statistical report: primary brain and other central nervous system tumors diagnosed in the United States in 2010–2014[J]. Neuro-oncology, 2017, 19(suppl_5): v1-v88.

    About TJ107/GX-I7

    TJ107/GX-I7 (efineptakin alpha) is the world's first and only long-acting recombinant human interleukin-7 (rhIL-7), known to boost T lymphocytes by increasing their number and functions. It emerged from Genexine's proprietary hyFc® platform for discovering of long-acting biologics.  I-Mab has acquired exclusive rights from Genexine to develop and commercialize TJ107/GX-I7 in Greater China. TJ107/GX-I7 may have utility in cancer treatment-related lymphopenia (low blood lymphocyte levels), a common condition that occurs in cancer patients who have received chemotherapy or radiation therapy, for which there is no approved treatment. TJ107/ GX-I7 has also been shown to synergize with a PD-1 antibody in various tumor animal models potentially through increased T-lymphocyte activation and proliferation.

    About I-Mab

    I-Mab (Nasdaq: IMAB) is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in  immuno-oncology therapeutic area. The Company's mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company's unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn, Twitter and WeChat.

    I-Mab Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the TJ107/GX-I7 phase 1/2 trial, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones and commercialization of TJ107/ GX-I7. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail:

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail:

    Office line: +86 21 6057 5785

    Investor Inquiries:

    The Piacente Group, Inc.

    Emilie Wu

    E-mail:

    Office line: + 86 21 6039 8363

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/i-mab-announces-first-patient-dosed-in-phase-2-clinical-trial-of-tj107-in-glioblastoma-multiforme-in-china-301222192.html

    SOURCE I-Mab

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  18. SHANGHAI, China and PLANEGG/MUNICH, Germany, Jan. 25, 2021 /PRNewswire/ -- I-Mab (NASDAQ:IMAB), and MorphoSys ((FSE: MOR, Prime Standard Segment, MDAX &, TecDAX, NASDAQ:MOR) today announced that the first patient has been dosed in a phase 1 dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TJ210/MOR210 monotherapy in patients with relapsed or refractory advanced solid tumors in the United States.

    TJ210/ MOR210 is a monoclonal antibody developed by MorphoSys that is directed against complement factor C5a receptor 1 (C5aR1). Produced in the tumoral microenvironment, its ligand C5a acts as a chemoattractant to recruit tumor-promoting cells such as myeloid-derived suppressor cells, M2 macrophages and neutrophils. TJ210/MOR210 is designed to induce anti-tumor properties by blocking the activation and migration of C5aR1-expressing myeloid cells.

    Preclinical studies have shown that targeting the C5aR-C5a axis exerts anti-tumor activity with immune checkpoint inhibitors. Furthermore, in vitro activity was observed for blocking the C5a/C5aR pathway also at very high C5a concentrations leading to a long duration of action. TJ210/MOR210 demonstrated a good safety profile with no observed adverse effects up to the highest dose tested in non-clinical safety studies.

    The phase 1 clinical trial is an open-label dose escalation study with multiple doses in multiple centers in the U.S. to evaluate the safety, tolerability, and PK/PD of TJ210/MOR210 in subjects with advanced solid tumors. The development program will evolve into further clinical combination studies of TJ210/MOR210 with checkpoint inhibitors. 

    "We are encouraged by the data observed in the preclinical studies and believe that TJ210/MOR210 with its unique properties has great potential to target difficult-to-treat cancers," said Dr. Joan Shen, CEO of I-Mab. "The data generated from this study will provide valuable information about TJ210/MOR210's safety and tolerability profile and its potential benefits in patients with advanced cancers."

    "We look forward to progressing with TJ210/MOR210 into clinical studies together with I-Mab to investigate its potential as a novel therapeutic option for patients with advanced solid tumors," said Dr. Malte Peters, Chief Research & Development Officer of MorphoSys.

    MorphoSys will receive a $1.5 million payment from I-Mab for achieving this milestone under the license agreement between the two companies. MorphoSys and I-Mab entered into an exclusive strategic collaboration and licensing agreement to develop and commercialize TJ210/MOR210 in November 2018. Under the terms of agreement, I-Mab receives exclusive rights to develop and commercialize TJ210/ MOR210 in Greater China and South Korea, while MorphoSys retains rights in other parts of the world. With support from MorphoSys, I-Mab will also fund and conduct all global development activities of TJ210/MOR210, including clinical trials in China and the U.S., towards clinical proof-of-concept (PoC) in oncology.

    About TJ210/MOR210

    TJ210/MOR210 is a novel human antibody directed against C5aR1 derived from MorphoSys's HuCAL Platinum® technology. C5aR1, the receptor of the complement factor C5a, is investigated as a potential new drug target in the field of immuno-oncology and autoimmune diseases. Tumors have been shown to produce high amounts of C5a, which, by recruiting and activating myeloid-derived suppressor cells (MDSCs), M2 macrophages and neutrophils, is assumed to contribute to an immune-suppressive pro-tumorigenic microenvironment. TJ210/MOR210 is intended to block the interaction between C5a and its receptor, thereby potentially neutralizing the immune suppressive function of C5a and enabling immune cells to attack the tumor.

    HuCAL Platinum® is a registered trademark of MorphoSys AG.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is an innovation-driven global biopharma company focused on the discovery, development and commercialization of novel and highly differentiated biologics for immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal discovery and global partnerships for in-licensing, based on the Company's Fast-to-Proof-of-Concept and Fast-to-Market development strategies. The Company is progressing from a clinical stage biotech company into a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, a world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedInTwitter and WeChat.

    About MorphoSys

    MorphoSys ((FSE &, NASDAQ:MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In 2017, Tremfya®, marketed by Janssen for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of the company's proprietary product Monjuvi® (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma. Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees.

    More information at www.morphosys.com or MorphoSys-US.com.

    Monjuvi® is a registered trademark of MorphoSys AG.

    Tremfya® is a registered trademark of Janssen Biotech.

    I-Mab Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the TJ210/MOR210 phase 1 trial, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones and commercialization of TJ210/MOR210. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    MorphoSys Forward-Looking Statements

    This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding the further clinical development of MOR210/TJ210, interactions with regulatory authorities and expectations regarding regulatory filings and possible approvals for MOR210/TJ210 as well as the potential future commercialization of MOR210/TJ210. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would," "could," "potential," "possible," "hope" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are MorphoSys' expectations regarding risks and uncertainties related to the impact of the COVID-19 pandemic to MorphoSys' business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products, the global collaboration and license agreement for MOR210/TJ210, the further clinical development of MOR210/TJ210, and MorphoSys' ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings , MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

    For more information, please contact:

    I-Mab

    Media Contact:

    Gigi Feng

    Chief Communications Officer

    +86 21 6057 5785

    Investor Contact:

    Jielun Zhu

    Chief Financial Officer

    +86 21 6057 8000

    MorphoSys

    Media Contacts:

    Thomas Biegi

    Vice President

    Tel.: +49 (0)89 / 89927 26079

     

    Investor Contacts:

    Dr. Julia Neugebauer

    Senior Director

    Tel: +49 (0)89 / 899 27 179

     

    Jeanette Bressi

    Director, US Communications

    Tel: +1 617-404-7816

    Myles Clouston

    Senior Director

    Tel: +1-857-772-0240

     

     

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  19. SHANGHAI and GAITHERSBURG, Md., Dec. 23, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced its participation in the following conferences in January. Details of the conferences and management presentation are as follows:

    H.C. Wainwright BioConnect 2021 Conference (Virtual)

    Presentation: Monday, January 11, 2021 at 6:00 a.m. EST

    Presenters: Dr. Jingwu Zang, Founder, Honorary Chairman and Director, Mr. Jielun Zhu, Director and Chief Financial Officer, and Ms. Leah Liu, Senior IR Director

    Webcast link: https://journey.ct.events/view/55113ae1-5386-4315-9899-fa6c5550c2b9. The webcast will also be available under "Event Calendar" on IMAB's IR website at http://ir.i-mabbiopharma.com/.

    For more information, please contact your H.C. Wainwright representative.

    Citi Greater China Healthcare Corporate Day 2021 (Virtual)

    Management participants: Dr. Jingwu Zang, Founder, Honorary Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Ms. Leah Liu, Senior IR Director

    One-on-one and small group meetings: January 14-15, 2021

    For more information, please contact your Citi representative.

    UBS Greater China Conference 2021 (Virtual)

    Management participants: Dr. Jingwu Zang, Founder, Honorary Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Ms. Leah Liu, Senior IR Director

    One-on-one and small group meetings: January 18-22, 2021

    For more information, please contact your UBS representative.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hangzhou, Hong Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn, Twitter and WeChat.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail:

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail:

    Office line: +86 21 6057 5785

    Investor Inquiries:

    The Piacente Group, Inc.

    Emilie Wu

    E-mail:

    Office line: + 86 21 6039 8363

     

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  20. SHANGHAI and GAITHERSBURG, Md., Dec. 14, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that I-Mab's American Depositary Shares (ADS) have been selected for inclusion in the NASDAQ Biotechnology Index (NASDAQ:NBI), based on the results of the annual reconstitution of the index announced by Nasdaq on December 11, 2020. The inclusion will become effective prior to the U.S. market open on Monday, December 21, 2020.

    Launched in 1993, the NBI is a modified market-cap weighted index designed to track the performance of a set of securities listed on The Nasdaq Stock Market® (Nasdaq®) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark (ICB). The NBI, as a major global biotech equity index, is widely followed and tracked by many investors and Exchange Traded Funds (ETF) products worldwide.

    Mr. Jielun Zhu, Director and Chief Financial Officer of I-Mab, said, "Since its IPO on Nasdaq in January 2020, I-Mab has successfully executed many important business milestones and significantly elevated its capital market profile. The inclusion in the NBI, following the first annual review by Nasdaq since our IPO, further validates I-Mab's progress and potential in delivering value to shareholders. We look forward to sharing many more achievements in 2021 and beyond."

    According to Nasdaq, the NBI is reconstituted annually in December in accordance with a set of eligibility criteria including minimum market capitalization and average daily trading volume. The index currently has 198 securities as its components. For more information about the NBI, please visit https://indexes.nasdaqomx.com/Index/Overview/NBI.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hangzhou, Hong Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn, Twitter and WeChat.

    Forward Looking Statements

    This press release includes certain disclosures which contain "forward-looking statements." You can identify forward-looking statements because they contain words such as "anticipate" and "expected." Forward-looking statements are based on I-Mab's current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in filings with the U.S. Securities and Exchange Commission. I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail:   

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail:   

    Office line: +86 21 6057 5785

    Investor Inquiries:

    The Piacente Group, Inc.

    Emilie Wu

    E-mail:

    Office line: + 86 21 6039 8363

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  21. SHANGHAI and GAITHERSBURG, Md., Dec. 4, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics, today announced the advancement of clinical development of the highly differentiated anti-CD47 monoclonal antibody lemzoparlimab (also known as TJC4) in the US and China, achieving milestones as planned. The Company is progressing its US combination trial (NCT03934814), studying lemzoparlimab in combination with Rituxan® and Keytruda® in dose expansion cohorts in non-Hodgkin lymphoma (NHL) and advanced solid tumors, respectively. The combination study with Rituxan® will enroll NHL patients from both…

    SHANGHAI and GAITHERSBURG, Md., Dec. 4, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics, today announced the advancement of clinical development of the highly differentiated anti-CD47 monoclonal antibody lemzoparlimab (also known as TJC4) in the US and China, achieving milestones as planned. The Company is progressing its US combination trial (NCT03934814), studying lemzoparlimab in combination with Rituxan® and Keytruda® in dose expansion cohorts in non-Hodgkin lymphoma (NHL) and advanced solid tumors, respectively. The combination study with Rituxan® will enroll NHL patients from both the US and China. Topline results from this study are expected next year.

    "The results from early investigational studies support the notion that lemzoparlimab is a differentiated CD47 antibody therapy for cancers that remains among the most common causes of death around the world," said Jordan Berlin, M.D. from Vanderbilt University, the principal investigator of the trial in the US. "As preclinical studies have suggested potential therapeutic effect when combined with other immuno-oncology drugs, we believe this warrants further study of the compound as a combination therapy."

    I-Mab is also poised to advance lemzoparlimab into late-stage clinical development in China. It will soon complete its ongoing phase 1/2a dose escalation trial (NCT04202003) to assess lemzoparlimab as monotherapy for patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) in China. The clinical results from this monotherapy dose escalation study will be presented at an appropriate scientific conference early next year.  

    Further, last week, China CDE accepted I-Mab's IND application to advance to a combination trial with azacitidine (AZA) in untreated AML or MDS. The open-label, multi-center combination trial will evaluate the safety, efficacy and tolerability of lemzoparlimab in combination with AZA in patients with newly diagnosed AML who are ineligible for intensive chemotherapy, or in patients with higher-risk MDS. The planned study builds upon the ongoing phase 1/2a monotherapy dose escalation trial and will potentially lead to a registrational study in China.

    "It has been reported and demonstrated that AZA can lead to significant increase of the 'eat me' signals on cancer cells. The combination of lemzoparlimab, which blocks the CD47 'don't eat me' signals on tumor cells, with AZA can greatly enhance macrophage activity to offer a strong therapeutic effect in patients," said Prof. Jianxiang Wang, principal investigator in China and Director at the Institute of Hematology, China Academy of Medical Services. "There are limited treatments available currently for those patients suffering from AML and MDS."

    I-Mab's global collaboration with AbbVie will facilitate global development of lemzoparlimab. In September, I-Mab and AbbVie entered into the partnership, subject to certain pre-closing conditions, to develop and commercialize lemzoparlimab, including design and conduct further clinical trials to evaluate lemzoparlimab globally including China. Both companies have jointly developed plans for the treatment of multiple cancers. 

    "Based on the strength of our data to-date, we have been able to rapidly advance the clinical development of lemzoparlimab. The progress we have made for our China and US trials, as well as our global partnership with AbbVie, has well positioned I-Mab to accelerate the clinical development towards a registrational trial and to be one step closer in benefiting cancer patients globally,"said Jingwu Zang, M.D., Ph.D., Founder, Honorary Chairman and Director of I-Mab.

    About CD47 and Lemzoparlimab

    CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don't eat me" signal to otherwise tumor-engulfing macrophages.  CD47 antibody blocks this signal and enables macrophages to attack tumor cells, making it a potentially promising cancer drug. However, development of CD47 antibody as a cancer therapy is hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. In a scientific breakthrough, scientists at I-Mab have discovered a unique CD47 antibody, lemzoparlimab, that works efficiently to target tumor cells while exerting a minimal untoward effect on red blood cells to avoid severe anemia.

    Lemzoparlimab's hematologic safety advantage and superb anti-tumor activities have been demonstrated previously in a series of robust pre-clinical studies. The results of phase 1 clinical trial have provided further clinical validation of this differentiation in patients with cancer. I-Mab continues to advance a combination study of lemzoparlimab with Keytruda® for solid tumors and with Rituxan® for lymphoma in the U.S., in addition to an on-going clinical trial in patients with AML in China.

    In September 2020, I-Mab and AbbVie entered into a global strategic partnership to develop and commercialize lemzoparlimab, including to design and conduct further clinical trials to evaluate lemzoparlimab in multiple cancers globally and in China. The collaboration is subject to certain pre-closing conditions.

    About Acute Myeloid Leukemia (AML)

    Acute Myeloid Leukaemia (AML) is a type of blood cancer that occurs due to the excessive production of myeloblasts, a specific type of white blood cell, in the bone marrow. Overall, AML is considered one of the most difficult-to-treat cancers, with poor survival rates (Oran, B., & Weisdorf, D. J., 2012). The five-year survival rate for patients diagnosed with AML remains approximately 29% (Institute, National Cancer, 2018).

    About I-Mab

    I-Mab (Nasdaq: IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hangzhou, Hong

    Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedInTwitter and WeChat.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the lemzoparlimab (TJC4) phase 1/2 trial, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones and commercialization of lemzoparlimab (TJC4). Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail:   

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail:   

    Office line: +86 21 6057 5785

    Investor Inquiries:

    Burns McClellan, Inc. (Americas and Europe)

    Steve Klass

    E-mail:

    Office line: +1 212 213 0006

    The Piacente Group, Inc. (Asia)

    Emilie Wu

    E-mail:

    Office line: + 86 21 6039 8363

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  22. SHANGHAI and GAITHERSBURG, Md., Dec. 1, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today filed a registration statement on Form F-1 with the Securities and Exchange Commission (the "SEC") by using a "shelf" registration process with respect to 25,123,751 ordinary shares of the Company (represented by 10,923,370 American depositary shares ("ADSs") beneficially owned by certain shareholders, which are parties to the privately negotiated subscription agreements with the Company dated September 3, 2020 (the "PIPE Agreements" and such parties, the "PIPE Investors").  

    A preliminary prospectus, which is part of…

    SHANGHAI and GAITHERSBURG, Md., Dec. 1, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today filed a registration statement on Form F-1 with the Securities and Exchange Commission (the "SEC") by using a "shelf" registration process with respect to 25,123,751 ordinary shares of the Company (represented by 10,923,370 American depositary shares ("ADSs") beneficially owned by certain shareholders, which are parties to the privately negotiated subscription agreements with the Company dated September 3, 2020 (the "PIPE Agreements" and such parties, the "PIPE Investors").  

    A preliminary prospectus, which is part of the registration statement on Form F-1, is available on the SEC's website at www.sec.gov. The ordinary shares represented by ADSs may not be sold nor may offers to buy be accepted prior to the time the registration statement on Form F-1 containing the preliminary prospectus becomes effective under the Securities Act of 1933, as amended.

    This announcement shall not constitute an offer to sell, or a solicitation of an offer to buy, the securities described herein, nor shall there be any offer, solicitation or sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About I-Mab

    I-Mab (Nasdaq: IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hangzhou, Hong

    Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedInTwitter and WeChat.

    Forward Looking Statements

    This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about I-Mab's beliefs and expectations, are forward-looking statements. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement. Further information regarding these and other risks is included in I-Mab's filings with the SEC. All information provided in this press release is as of the date of this press release, and I-Mab does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail:   

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail:   

    Office line: +86 21 6057 5785

    Investor Inquiries:

    Burns McClellan, Inc. (Americas and Europe)

    Steve Klass

    E-mail:

    Office line: +1 212 213 0006

    The Piacente Group, Inc. (Asia)

    Emilie Wu

    E-mail:

    Office line: + 86 21 6039 8363

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  23. SHANGHAI and GAITHERSBURG, Md., Dec. 1, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced the strengthening of its Scientific Advisory Board ("SAB") with the appointment of leading international experts Dr. Chen Dong and Dr. Jun Ma. Both will contribute their esteemed depth of expertise in immunology and hematology to provide scientific review and advise the Company on research and development programs.   

    "We are honored and delighted to welcome Dr. Dong and Dr. Ma to our scientific advisory board," said Dr. Jingwu Zang, Founder, Honorary Chairman and Director of I-Mab. "Dr. Dong is a globally…

    SHANGHAI and GAITHERSBURG, Md., Dec. 1, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced the strengthening of its Scientific Advisory Board ("SAB") with the appointment of leading international experts Dr. Chen Dong and Dr. Jun Ma. Both will contribute their esteemed depth of expertise in immunology and hematology to provide scientific review and advise the Company on research and development programs.   

    "We are honored and delighted to welcome Dr. Dong and Dr. Ma to our scientific advisory board," said Dr. Jingwu Zang, Founder, Honorary Chairman and Director of I-Mab. "Dr. Dong is a globally recognized leader in the field of immunology and Dr. Ma is a distinguished pioneer in hematology and oncology. I-Mab will greatly benefit from their experience and expertise in their respective fields as we advance our mission to bring transformational medicines to patients around the world through innovation."

    "I-Mab has built a leading position in immuno-oncology and I have been impressed with what this company has been able to accomplish in research and clinical development. I look forward to bringing my expertise to the advisory board and contributing to I-Mab's rapid growth, in China and globally," said Dr. Chen Dong.

    Dr. Dong is currently Professor and Director of the Institute for Immunology at Tsinghua University, and a principal investigator at Shanghai Renji Hospital. He is a fellow of the American Association for the Advancement of Science and a member of the Chinese Academy of Sciences. Dr. Dong specializes in immunology, and his transformative research has led to ground-breaking discoveries in the field of T cell biology and interleukin (IL)-17 family cytokines. His research focuses on understanding the molecular mechanisms whereby immune and inflammatory responses are normally regulated, and to apply this knowledge to the understanding and treatment of autoimmunity and allergy disorders as well as cancer. With over 200 publications, Dr. Dong has been rated a highly cited researcher for seven consecutive years from 2014 to 2020. He is the recipient of several distinguished awards, including the 2009 American Association of Immunologists-BD Bioscience Investigator Award and the 2019 International Cytokine and Interferon Society Biolegend-William E. Paul Award.

    "I-Mab is developing advanced and innovative programs in novel anti-cancer therapies. The company is well-positioned to bring to patients target therapies in areas of significant unmet need, and I am pleased to be joining at such an exciting stage in its growth," said Dr. Jun Ma.

    Dr. Ma is currently Director of the Harbin Institute of Hematology & Oncology, and Chief Supervisor of Supervisory Committee at the Chinese Society of Clinical Oncology. He started his studies in the University of Tokyo Hospital and, over the decades, his research focused on treatments for leukemia and lymphoma. He was the first to establish a culture system for multiple hematopoietic progenitor cells in vitro in China. Since 1983, he has used sequential therapy of all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) to treat acute promyelocytic leukemia (APL) for about 1200 cases. Dr. Ma has published about 200 articles and conducted 8 China's National R&D Programs and 25 provincial or municipal-level projects. He is highly recognized as the leader in hematology in China.

    Dr. Dong and Dr. Ma join existing SAB members Patricia LoRusso, Eric K. Rowinsky, Howard L. Weiner, Yilong Wu, Timothy A. Yap and Roy S. Herbst.

    About I-Mab

    I-Mab (Nasdaq: IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hangzhou, Hong Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn, Twitter and WeChat.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail:

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail:

    Office line: +86 21 6057 5785

    Investor Inquiries:

    Burns McClellan, Inc. (Americas and Europe)

    Steve Klass

    E-mail:

    Office line: +1 212 213 0006

    The Piacente Group, Inc. (Asia)

    Emilie Wu

    E-mail:

    Office line: + 86 21 6039 8363

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/i-mab-appoints-leading-immunology-and-hematology-experts-to-its-scientific-advisory-board-301182310.html

    SOURCE I-Mab

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  24. SHANGHAI and GAITHERSBURG, Md., Nov. 13, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that it will hold a call with investors on Friday, November 13 at 8:20 a.m. ET to provide deep dive analysis of preliminary clinical efficacy results of its U.S. phase 1 clinical trial (NCT03934814) evaluating lemzoparlimab (also known as TJC4) for the treatment of relapsed or refractory solid tumors. The results are being presented this week at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting. The purpose of the call is to provide an expanded analysis of the clinical efficacy signal from…

    SHANGHAI and GAITHERSBURG, Md., Nov. 13, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that it will hold a call with investors on Friday, November 13 at 8:20 a.m. ET to provide deep dive analysis of preliminary clinical efficacy results of its U.S. phase 1 clinical trial (NCT03934814) evaluating lemzoparlimab (also known as TJC4) for the treatment of relapsed or refractory solid tumors. The results are being presented this week at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting. The purpose of the call is to provide an expanded analysis of the clinical efficacy signal from the U.S. phase 1 clinical trial, which is not previously discussed.  

    Please click here to access the meeting presentation.

    I-Mab Conference Call and Webcast Information

    Investors and analysts are invited to join the conference call on November 13 at 8:20 a.m. ET using the following dial-in information:

    United States:

    +1-866-519-4004

    International:         

    +65-6713-5090

    Mainland China:

    400-620-8038

    Hong Kong:

    800-906-601

    Conference ID:

    4556519

    A live webcast and an archived replay of the conference call can be accessed on the Company's investor relations website at http://ir.i-mabbiopharma.com.

    A telephone replay will be available approximately two hours after the conclusion of the call by dialing +1 855-452-5696 (U.S.), +61 2 8199-0299 (International), 400-632-2162 (Mainland China), or 800-963-117 (Hong Kong). The conference ID number for the replay is 4556519. The replay will be available through November 20, 2020.

    About CD47 and Lemzoparlimab

    CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don't eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells, making it a potentially promising cancer drug. However, development of CD47 antibody as a cancer therapy is hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. In a scientific breakthrough, scientists at I-Mab have discovered a unique CD47 antibody, lemzoparlimab, that works efficiently to target tumor cells while exerting minimal untoward effect on red blood cells, thus avoiding severe anemia.

    Lemzoparlimab's hematologic safety advantage and superb anti-tumor activities have been demonstrated previously in a series of robust pre-clinical studies. The results of the phase 1 clinical trial have provided further, clinical validation of this differentiation in patients with cancer. I-Mab continues to advance a combination study of lemzoparlimab with Keytruda® for the treatment of solid tumors and with Rituxan® for the treatment of patients with lymphoma in the U.S., in addition to an ongoing clinical trial with patients with AML/MDS in China.

    In September 2020, I-Mab and AbbVie entered into a global strategic partnership to develop and commercialize lemzoparlimab, including to design and conduct further clinical trials to evaluate lemzoparlimab in multiple cancers globally and in China. The collaboration is subject to certain pre-closing conditions.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hangzhou, Hong Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn, Twitter and WeChat.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the lemzoparlimab (TJC4) phase 1 trial, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones and commercialization of lemzoparlimab (TJC4). Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail:   

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail:   

    Office line: +86 21 6057 5785

    Investor Inquiries:

    Burns McClellan, Inc. (Americas and Europe)

    Steve Klass

    E-mail:

    Office line: +1 212 213 0006

    The Piacente Group, Inc. (Asia)

    Emilie Wu

    E-mail:

    Office line: + 86 21 6039 8363

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/i-mab-to-hold-investor-call-and-expand-clinical-data-analysis-on-efficacy-signal-of-lemzoparlimab-from-phase-1-clinical-trial-301172669.html

    SOURCE I-Mab

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  25. SHANGHAI and GAITHERSBURG, Md., Nov. 11, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced new preclinical data from in vivo and in vitro studies of its C5aR antibody project, TJ210/MOR210, at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting. The data will be shared in an oral presentation entitled "TJ210 (MOR210), A Differentiated Anti-C5aR Antibody for Anti-Cancer Therapy", on November 12, 2020 at 11:30 am EST (Abstract #607).

    Complement component fragment 5a receptor (C5aR1, CD88) is a G-protein coupled receptor (GPCR) that is being investigated as a potential new drug target in the field of immuno-oncology. Produced in the tumoral microenvironment, C5a acts as a chemoattractant to recruit, through its C5aR1 receptor, tumor-promoting cells such as myeloid derived suppressive cells (MDSCs), neutrophils and M2 macrophages to the tumor site, resulting in the inhibition of tumor-attacking immune cells and promotion of tumor progression.

    TJ210/MOR210 is an anti-C5aR monoclonal antibody in-licensed from MorphoSys. It is designed to interact with the N-terminus of C5aR1 and induces anti-tumor properties by blocking the activation and migration of C5aR1-expressing myeloid cells. Key results from preclinical studies show that: 

    • TJ210/MOR210 selectively binds to the N-terminus of C5aR1 with high affinity and is not cross-reactive to other related GPCRs.
    • Blockade of C5a/C5aR pathway inhibits the recruitment of tumor promoting cells, leading to the significant inhibition of tumor growth when combining with another immuno-oncology therapy, e.g. anti-PD-1 antibody.
    • TJ210/MOR210 demonstrated a good safety profile of a 4-week repeat dose GLP toxicity study in cynomolgus monkeys, with no observed adverse effects up to the highest dose tested at 200 mg/kg and no impact on neutrophils.

    "TJ210/MOR210 is one of the innovative monoclonal antibodies in our differentiated pipeline that brings together the best of science in immuno-oncology," said Dr. Joan Shen, CEO of I-Mab. "We are eager to advance this innovative program in clinical development, which has the potential to address the unmet need in cancer for patients around the world."

    The preclinical data provide new understanding of the underlying mechanism of TJ210/MOR210 and a strong scientific rationale for TJ210/MOR210 to be further evaluated as a potential treatment for cancers. I-Mab and MorphoSys recently announced that the U.S. Food & Drug Administration approved the Investigational New Drug (IND) application to initiate a phase 1 trial of TJ210/MOR210 for the treatment of relapsed or refractory advanced solid tumors.

    About TJ210/MOR210

    TJ210/MOR210 is a novel human antibody directed against C5aR derived from MorphoSys's HuCAL Platinum® technology. C5aR, the receptor of the complement factor C5a, is investigated as a potential new drug target in the field of immuno-oncology and autoimmune diseases. Tumors have been shown to produce high amounts of C5a, which, by recruiting and activating myeloid-derived suppressor cells (MDSCs), M2 macrophages and neutrophils, is assumed to contribute to an immune-suppressive pro-tumorigenic microenvironment. TJ210/MOR210 is intended to block the interaction between C5a and its receptor, thereby potentially neutralizing the immune suppressive function of C5a and enabling immune cells to attack the tumor.

    HuCAL Platinum® is a registered trademark of MorphoSys AG.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hangzhou, Hong Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn, Twitter and WeChat.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the TJ210 preclinical and clinical studies, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones and commercialization of TJ210. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail:

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail:

    Office line: +86 21 6057 5785

    Investor Inquiries:

    Burns McClellan, Inc. (Americas and Europe)

    Steve Klass

    E-mail:

    Office line: +1 212 213 0006

    The Piacente Group, Inc. (Asia)

    Emilie Wu

    E-mail:

    Office line: + 86 21 6039 8363

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/i-mab-announces-preclinical-data-on-differentiated-anti-c5ar-antibody-tj210mor210-at-sitc-2020-301170813.html

    SOURCE I-Mab

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  26. SHANGHAI and GAITHERSBURG, Md., Nov. 9, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced initial results from its U.S. phase 1 clinical trial (NCT03934814) evaluating lemzoparlimab (also known as TJC4) for the treatment of relapsed or refractory solid tumors and lymphoma. The results were released in a poster entitled "A first-in-patient study of lemzoparlimab, a differentiated anti-CD47 antibody, in subjects with relapsed/refractory malignancy: initial monotherapy results" at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting, on November 9, 2020 (Abstract #385).  

    SHANGHAI and GAITHERSBURG, Md., Nov. 9, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced initial results from its U.S. phase 1 clinical trial (NCT03934814) evaluating lemzoparlimab (also known as TJC4) for the treatment of relapsed or refractory solid tumors and lymphoma. The results were released in a poster entitled "A first-in-patient study of lemzoparlimab, a differentiated anti-CD47 antibody, in subjects with relapsed/refractory malignancy: initial monotherapy results" at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting, on November 9, 2020 (Abstract #385).  

    Lemzoparlimab is a unique CD47 antibody that exerts strong anti-tumor activity while exhibiting a minimal binding to red blood cells. It is designed to avoid severe anemia -- a common toxicity of CD47 antibodies of the same class.

    "Lemzoparlimab was originally discovered and developed by I-Mab as a globally competitive CD47 antibody and has been uniquely designed to overcome the toxicity associated with this drug target," said Jingwu Zang, M.D., Ph.D., Founder, Honorary Chairman and Director of I-Mab. "The initial clinical results are consistent with the key differentiation of lemzoparlimab in terms of drug safety and the PK profile. These clinical advantages put lemzoparlimab in a highly competitive position among CD47 antibodies of the same class."

    The phase 1 study is an open-label, multi-center, multiple dose study conducted in two parts. The first part is comprised of a single agent dose escalation followed by two separate combination regimens in an escalating dose range (Part 1b with pembrolizumab; Part 1c with rituximab). The second part is a dose expansion study in the combination therapies.

    The data to be presented at SITC include the initial results from the single agent therapy (N=20), which is designed to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of lemzoparlimab. The key findings include:

    • Lemzoparlimab was well tolerated up to 30 mg/kg on a weekly basis without priming dosing strategy. No dose-limiting toxicity and no clinical or laboratory evidence of hemolytic anemia were observed throughout.
    • Lemzoparlimab PK appears to be linear at mid to high dose levels following a single dose with no significant "sink effect".
    • One confirmed Partial Response (PR) was observed in the 30 mg/kg monotherapy cohort (N=3). The patient had failed prior treatments with checkpoint inhibitors.

    "We are very encouraged by the safety and tolerability data that have emerged from the phase 1 trial," said Jordan Berlin, M.D. from Vanderbilt University, the principal investigator of the trial. "It shows the promise of lemzoparlimab as a differentiated CD47 antibody for multiple cancers, and we look forward to advancing the development of lemzoparlimab for patients with advanced solid tumors and hematologic malignancies."  Dr. Berlin will present the data during the virtual poster sessions on November 11, 2020 5:15-5:45 p.m. EST and November 13, 2020 4:40-5:10 p.m. EST.

    Recruitment of patients for the dose escalation study of lemzoparlimab in combination with pembrolizumab or rituximab is ongoing. Additional information on the clinical trial (NCT03934814) is available on www.clinicaltrials.gov.

    In September 2020, I-Mab and AbbVie entered into a global strategic partnership to develop and commercialize lemzoparlimab. Subject to pre-closing conditions, both companies will be collaborating to further advance the clinical development of lemzoparlimab for the treatment of multiple cancers globally and in China.  

    I-Mab Conference Call and Webcast Information

    Investors and analysts are invited to join the conference call today at 8:30 a.m. ET using the following dial-in information:

    United States:

    +1-888-346-8982

    International:         

    +1-412-902-4272

    Mainland China:

    400-120-1203

    Hong Kong:

    800-905-945

    Conference ID:

    10149942

    A live webcast and an archived replay of the conference call can be accessed on the Company's investor relations website at http://ir.i-mabbiopharma.com.

    A telephone replay will be available approximately two hours after the conclusion of the call by dialing +1-877-344-7529 (U.S.), 1-412-317-0088 (International). The conference ID number for the replay is 10149942. The replay will be available through November 16, 2020.

    About CD47 and Lemzoparlimab

    CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don't eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells, making it a potentially promising cancer drug. However, development of CD47 antibody as a cancer therapy is hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. In a scientific breakthrough, scientists at I-Mab have discovered a unique CD47 antibody, lemzoparlimab, that works efficiently to target tumor cells while exerting minimal untoward effect on red blood cells, thus avoiding severe anemia.

    Lemzoparlimab's hematologic safety advantage and superb anti-tumor activities have been demonstrated previously in a series of robust pre-clinical studies. The results of the phase 1 clinical trial have provided further, clinical validation of this differentiation in patients with cancer. I-Mab continues to advance a combination study of lemzoparlimab with Keytruda® for the treatment of solid tumors and with Rituxan® for the treatment of patients with lymphoma in the U.S., in addition to an ongoing clinical trial with patients with AML/MDS in China.

    In September 2020, I-Mab and AbbVie entered into a global strategic partnership to develop and commercialize lemzoparlimab, including to design and conduct further clinical trials to evaluate lemzoparlimab in multiple cancers globally and in China. The collaboration is subject to certain pre-closing conditions.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hangzhou, Hong Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn, Twitter and WeChat.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the lemzoparlimab (TJC4) phase 1 trial, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones and commercialization of lemzoparlimab (TJC4). Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail:

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail:

    Office line: +86 21 6057 5785

    Investor Inquiries:

    Burns McClellan, Inc. (Americas and Europe)

    Steve Klass

    E-mail:

    Office line: +1 212 213 0006

    The Piacente Group, Inc. (Asia)

    Emilie Wu

    E-mail:

    Office line: + 86 21 6039 8363

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/i-mab-reports-phase-1-clinical-trial-data-of-highly-differentiated-anti-cd47-monoclonal-antibody-lemzoparlimab-at-the-2020-sitc-annual-meeting-301168649.html

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  27. SHANGHAI, Nov. 8, 2020 /PRNewswire/ -- Inmagene Biopharmaceuticals ("Inmagene"), announced today that it had closed a $21 million Series B financing, led by Vertex Ventures China, and co-invested by Panacea Venture, Kunlun Capital, SCVC and a few other investors.   The Series B financing will be mainly used to conduct global clinical trials, research and development, and product in-licensing activities. To date, Inmagene has raised over $40 million financing. 

    Inmagene is a leading drug development company focused on immunology-related therapeutic areas.   Its management team has strong global experience and is deeply rooted in China.  In prior experience, the team members in-licensed over 30 global products for China, led research and development…

    SHANGHAI, Nov. 8, 2020 /PRNewswire/ -- Inmagene Biopharmaceuticals ("Inmagene"), announced today that it had closed a $21 million Series B financing, led by Vertex Ventures China, and co-invested by Panacea Venture, Kunlun Capital, SCVC and a few other investors.   The Series B financing will be mainly used to conduct global clinical trials, research and development, and product in-licensing activities. To date, Inmagene has raised over $40 million financing. 

    Inmagene is a leading drug development company focused on immunology-related therapeutic areas.   Its management team has strong global experience and is deeply rooted in China.  In prior experience, the team members in-licensed over 30 global products for China, led research and development for over 20 NDAs, obtained market approvals in 28 countries, gained 6 INDs in China and the United States, and played important roles in the founding of Zai Lab (NASDAQ:ZLAB), I-Mab (NASDAQ:IMAB) and Apollomics.

    Inmagene's pipeline is driven by two "engines". First, Inmagene in-licenses clinical-stage foreign products which fit China, and, together with its overseas partners, carries out global multi-center clinical trials . Also, Inmagene utilizes China's cost-efficient resources to develop drugs with best-in-class potentials.  It has initiated four innovative programs for validated drug targets.  IMG-20, Inmagene's most advanced drug candidate, is about to enter the global registration trials for multiple indications.

    "We are grateful to Vertex, Panacea, Kunlun, SCVC and other investors for their strong support," said Dr. Jonathan Wang, Chairman and CEO of Inmagene. "This financing should help strengthen Inmagene's leading position in immunology drug development in China."

    Mr. Tay Choon Chong, Managing Partner at Vertex Ventures China, said, "We are honored to participate in Inmagene's Series B financing as the lead investor.  The development of drugs for immunology-related diseases is still a 'blue ocean' in China. Inmagene has made an early breakthrough in this field and has established a strong R&D pipeline. It is a great pleasure to partner with Dr. Jonathan Wang and grow with Inmagene. We believe that, with strong innovative capabilities and a broad global vision, Inmagene will be able to develop more globally competitive products to meet patients' needs.

    About Inmagene Biopharmaceuticals 

    Inmagene, with wholly owned subsidiaries in Shanghai, Hangzhou and Beijing, is one of the leading companies in immunology drug development in China. Its product pipeline includes drug candidates with first-in-class or best-in-class potentials, among which IMG-020 is about to enter global registration clinical trials for multiple indications.

    For additional information about Inmagene Biopharmaceuticals, please visit www.inmagenebio.com

    About Vertex Ventures China (VVC)

    Vertex Ventures is a leading global VC firm with its headquarters in Singapore. With both USD and RMB funds, totaling over $1.5 billion under management, VVC is a part of Vertex's global network of funds.   Focused on healthcare, deep tech and new digital economy, VVC has been named "China's TOP 20 Healthcare VC firms of 2019-2020" by 36Kr.

    For more information, please visit www.vertexventures.cn/en/

     

     

     

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  28. SHANGHAI, China, and GAITHERSBURG, MD., Oct. 28, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced its participation in the following conferences in November. Details of the conferences and management presentation are as follows:

    11th Credit Suisse China Investment Conference (Virtual)

    Management participants: Mr. Jielun Zhu, Director and Chief Financial Officer and Ms. Leah Liu, Senior IR Director

    One-on-one and small group meetings: November 2 & 5, 2020

    For more information, please contact your Credit Suisse representative.

    15th Citi China Investor Conference 2020 (Virtual)

    Management participants: Dr. Jingwu Zang, Founder, Honorary Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Ms. Leah Liu, Senior IR Director

    One-on-one and small group meetings: November 3-5, 2020

    For more information, please contact your Citi representative.

    CICC Investment Forum (Beijing) 2020

    Management participant: Mr. Jielun Zhu, Director and Chief Financial Officer

    Location: Kerry Hotel, Beijing, China

    One-on-one and small group meetings: November 11-12, 2020

    For more information, please contact your CICC representative.

    Nomura Investment Forum 2020 (Virtual)

    Management participants: Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Ms. Leah Liu, Senior IR Director

    Large group meetings: November 13, 2020

    For more information, please contact your Nomura representative.

    Goldman Sachs Asia Pacific Healthcare Forum 2020 (Virtual)

    Panel Discussion: Tuesday, November 17, 2020 at 10:00 a.m. HKT

    Panelist: Dr. Joan Huaqiong Shen, Director and Chief Executive Officer

    One-on-one and small group meetings: November 16-18, 2020

    Management participants: Mr. Jielun Zhu, Director and Chief Financial Officer and Ms. Leah Liu, Senior IR Director

    For more information, please contact your Goldman Sachs representative.

    Jefferies London Healthcare Conference (Virtual)

    Presentation: Tuesday, November 17, 2020 at 12:55-1:25 p.m. GMT

    Presenter: Dr. Joan Huaqiong Shen, Director and Chief Executive Officer

    Webcast link: https://wsw.com/webcast/jeff141/imab/1814025  The webcast will also be available under "Event Calendar" on IMAB's IR website at http://ir.i-mabbiopharma.com/ .

    One-on-one meetings: November 17-19, 2020

    Management participants: Dr. Jingwu Zang, Founder, Honorary Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Ms. Leah Liu, Senior IR Director

    For more information, please contact your Jefferies representative.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hangzhou, Hong Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn and WeChat.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail:

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail:

    Office line: +86 21 6057 8000

    Investor Inquiries:

    Burns McClellan, Inc. (Americas and Europe)

    Steve Klass

    E-mail:

    Office line: +1 212 213 0006

    The Piacente Group, Inc. (Asia)

    Emilie Wu

    E-mail:

    Office line: + 86 21 6039 8363

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/i-mab-announces-upcoming-participation-at-november-conferences-301161665.html

    SOURCE I-Mab

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  29. SHANGHAI and GAITHERSBURG, Md., Oct. 27, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the Company will present the latest preclinical data from its C5aR program, TJ210 at the Society for Immunotherapy of Cancer's 35th Anniversary Annual Meeting & Pre-Conference Programs (SITC 2020), taking place online November 9 – 14, 2020. The preclinical data will provide a rationale for the use of TJ210 as a monotherapy or in combination with immune checkpoint inhibitors such as anti PD-1 therapies as anti-tumor agent.

    Complement component fragment 5a receptor (C5aR1, CD88) is a G-protein coupled receptor…

    SHANGHAI and GAITHERSBURG, Md., Oct. 27, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the Company will present the latest preclinical data from its C5aR program, TJ210 at the Society for Immunotherapy of Cancer's 35th Anniversary Annual Meeting & Pre-Conference Programs (SITC 2020), taking place online November 9 – 14, 2020. The preclinical data will provide a rationale for the use of TJ210 as a monotherapy or in combination with immune checkpoint inhibitors such as anti PD-1 therapies as anti-tumor agent.

    Complement component fragment 5a receptor (C5aR1, CD88) is a G-protein coupled receptor (GPCR) and is being investigated as a potential new drug target in the field of immuno-oncology. C5a is produced in the tumoral microenvironment which acts as a chemoattractant to recruit through one of its receptors namely C5aR1 pro-tumor cells such as myeloid derived suppressive cells (MDSCs), neutrophils and M2 macrophages to the tumor site to suppress the human immune system attacking on the cancer and accelerate tumor progression.

    TJ210 is an anti-C5aR monoclonal antibody in-licensed from MorphoSys, designed to bind to a unique epitope on C5aR1, thereby aimed to block the recruitment of pro-tumor cells into the tumor microenvironment.

    Details of the oral presentation are as follows:

    Title

    TJ210 (MOR210), A Differentiated Anti-C5aR Antibody for Anti-Cancer Therapy

    Abstract #

    607

    Presenting Author

    Jane Meng, PhD, I-Mab Biopharma

    Presentation Time

    11:30 am – 11:45 am (EST), Thursday, November 12 

    Visit SITC website for more abstract information.

    About TJ210/MOR210

    TJ210/MOR210 is a novel human antibody directed against C5aR derived from MorphoSys's HuCAL Platinum® technology. C5aR, the receptor of the complement factor C5a, is investigated as a potential new drug target in the field of immuno-oncology and autoimmune diseases. Tumors have been shown to produce high amounts of C5a, which, by recruiting and activating myeloid-derived suppressor cells (MDSCs), M2 macrophages and neutrophils, is assumed to contribute to an immune-suppressive pro-tumorigenic microenvironment. TJ210/MOR210 is intended to block the interaction between C5a and its receptor, thereby potentially neutralizing the immune suppressive function and enabling immune cells to attack the tumor.

    HuCAL® and HuCAL Platinum® are registered trademarks of MorphoSys AG.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hangzhou, Hong Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn and WeChat.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the TJ210/MOR210, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones and commercialization of TJ210/MOR210. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail:

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail:

    Office line: +86 21 6057 8000

    Investor Inquiries:

    Burns McClellan, Inc. (Americas and Europe)

    Steve Klass

    E-mail:

    Office line: +1 212 213 0006

    The Piacente Group, Inc. (Asia)

    Emilie Wu

    E-mail:

    Office line: + 86 21 6039 8363

     

    Cision View original content:http://www.prnewswire.com/news-releases/i-mab-to-present-preclinical-data-of-tj210-at-the-2020-society-for-immunotherapy-of-cancer-sitc-annual-meeting-301160575.html

    SOURCE I-Mab

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  30. SHANGHAI and GAITHERSBURG, Md., Oct. 15, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the Company's abstract highlighting its U.S. phase 1 dose escalation trial data from its CD47 program, lemzoparlimab (also known as TJC4) in relapsed or refractory malignancy, will be presented at the Society for Immunotherapy of Cancer's 35th Anniversary Annual Meeting & Pre-Conference Programs (SITC 2020), taking place online November 9 - 14, 2020. The data to be presented will include clinical safety, pharmacokinetics (PK) & pharmacodynamics (PD), receptor occupancy (RO), and preliminary evidence of…

    SHANGHAI and GAITHERSBURG, Md., Oct. 15, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the Company's abstract highlighting its U.S. phase 1 dose escalation trial data from its CD47 program, lemzoparlimab (also known as TJC4) in relapsed or refractory malignancy, will be presented at the Society for Immunotherapy of Cancer's 35th Anniversary Annual Meeting & Pre-Conference Programs (SITC 2020), taking place online November 9 - 14, 2020. The data to be presented will include clinical safety, pharmacokinetics (PK) & pharmacodynamics (PD), receptor occupancy (RO), and preliminary evidence of efficacy of lemzoparlimab as a monotherapy.

    Lemzoparlimab is a highly differentiated anti-CD47 monoclonal antibody originally discovered and developed by I-Mab that has been designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity, a critical attribute in differentiating lemzoparlimab from other antibodies of the same class currently in clinical development. Initial results from I-Mab's phase 1 study in U.S. described above have demonstrated the unique differentiation in drug safety and pharmacokinetics profile in cancer patients.

    Details of the poster are as follows:

    Title

    A first-in-patient study of lemzoparlimab, a differentiated anti-CD47 antibody,

    in subjects with relapsed/refractory malignancy: initial monotherapy results

    Abstract #

    385

    Presenting Author

    Jordan Berlin, MD, Vanderbilt University

    The abstract is available at https://sitc.sitcancer.org/2020/abstracts/titles/

    About CD47 and Lemzoparlimab

    CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don't eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells, making it a potentially promising cancer drug. However, development of CD47 antibody as a cancer therapy is hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. In a scientific breakthrough, scientists at I-Mab have discovered a unique CD47 antibody, lemzoparlimab, that works efficiently to target tumor cells while exerting a minimal untoward effect on red blood cells to avoid severe anemia. 

    Lemzoparlimab's hematologic safety advantage and superb anti-tumor activities have been demonstrated previously in a series of robust pre-clinical studies. The results of phase 1 clinical trial have provided further clinical validation of this differentiation in patients with cancer. I-Mab continues to advance a combination study of lemzoparlimab with Keytruda® for solid tumor and with Rituxan® for lymphoma in the U.S., in addition to an on-going clinical trial in patients with AML/MDS in China.

    In September 2020, I-Mab and AbbVie entered into a global strategic partnership to develop and commercialize lemzoparlimab, including to design and conduct further clinical trials to evaluate lemzoparlimab in multiple cancers globally and in China. The collaboration is subject to certain pre-closing conditions. 

    About I-Mab

    I-Mab (NASDAQ:IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hangzhou, Hong Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn and WeChat.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the lemzoparlimab (TJC4) phase 1 trial, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones and commercialization of lemzoparlimab (TJC4). Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, CFO

    E-mail:

    Office line: +86 21 6057 8000

    Gigi Feng, Vice President and Global Head of Corporate Communications

    E-mail:

    Office line: +86 21 6057 8000

    Investor Inquiries:

    Burns McClellan, Inc. (Americas and Europe)

    Steve Klass

    E-mail:

    Office line: +1 212 213 0006

    The Piacente Group, Inc. (Asia)

    Emilie Wu

    E-mail:

    Office line: +86 21 6039 8363

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/i-mab-to-present-phase-1-data-of-lemzoparlimab-at-the-2020-society-for-immunotherapy-of-cancer-sitc-annual-meeting-301153041.html

    SOURCE I-Mab

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  31. SHANGHAI and GAITHERSBURG, Md., Sept. 30, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the China Center for Drug Evaluation (CDE) has approved the pivotal trial application for eftansomatropin (also known as TJ101) as a weekly treatment for growth hormone deficiency in pediatric patients (PGHD).

    I-MAB Logo (PRNewsfoto/I-Mab Biopharma)

    Eftansomatropin is an innovative long-acting rhGH with a novel molecular format utilizing Genexine's patented half-life extension hyFc® fusion technology, which stimulates the production of insulin-like growth factor 1 (IGF-1) in the liver, alongside growth-stimulating effects on a variety of…

    SHANGHAI and GAITHERSBURG, Md., Sept. 30, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the China Center for Drug Evaluation (CDE) has approved the pivotal trial application for eftansomatropin (also known as TJ101) as a weekly treatment for growth hormone deficiency in pediatric patients (PGHD).

    I-MAB Logo (PRNewsfoto/I-Mab Biopharma)

    Eftansomatropin is an innovative long-acting rhGH with a novel molecular format utilizing Genexine's patented half-life extension hyFc® fusion technology, which stimulates the production of insulin-like growth factor 1 (IGF-1) in the liver, alongside growth-stimulating effects on a variety of tissues, including osteoblast and chondrocyte activities that stimulate bone growth. Because of its unique features, eftansomatropin may have some long term safety advantages over the conventional pegylated rhGH drugs. In phase 1 and 2 clinical studies, eftansomatropin was shown to be well-tolerated, and clinical efficacy of weekly or biweekly regimens was comparable to the daily injected rhGH (genotropin).

    "The planned initiation of our phase 3 study for eftansomatropin marks a critical milestone not just for I-Mab, but for pediatric patients with growth hormone deficiency broadly," said Dr. Joan Shen, CEO of I-Mab. "We hope to bring an innovative therapy, such as eftansomatropin, that is safe, efficacious and convenient for pediatric patients once proven."

    The phase 3 trial is a multi-center, randomized, open-label, active-controlled clinical study designed to assess the safety, efficacy and pharmacokinetics of eftansomatropin in PGHD. The primary objective is to demonstrate non-inferiority of eftansomatropin administered in subcutaneous injection, compared to the active control Norditropin® (somatropin), a daily rhGH marketed in China.

    I-Mab owns the rights of eftansomatropin from Genexine Inc. (KOSDAQ: 095700) for development, manufacturing and commercialization in China. According to Frost & Sullivan, only 3.7% of 3.4 million pediatric patients in Greater China with growth hormone deficiency receive growth hormone therapies, which primarily consist of daily injections of rhGH. Recombinant human growth hormone therapy has been included in the National Reimbursement Drug List in China.

    About eftansomatropin

    Eftansomatropin is a potential highly differentiated long-acting recombinant human growth hormone being developed as a more convenient and effective therapy for GHD. Like endogenous growth hormone, eftansomatropin stimulates the production of insulin-like growth factor 1 in the liver, which has growth-stimulating effects on a variety of tissues, including osteoblast and chondrocyte activities that stimulate bone growth. IGF-1 is a reliable pharmacodynamic marker and the key mediator of growth-promoting activity of eftansomatropin. Eftansomatropin is based on Genexine's patented hyFc® technology. The hyFc part consists of a portion of human immunoglobulin D ("IgD") and G4 ("IgG4"). The former contains a flexible hinge, and the latter is responsible for half-life extension through neonatal Fc receptor ("FcRn")-mediated recycling.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hong Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the eftansomatropin (TJ101) clinical trials, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones and commercialization of eftansomatropin (TJ101). Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, CFO

    E-mail:

    Office line: +86 21 6057 8000

    Gigi Feng, Vice President and Global Head of Corporate Communications

    E-mail:

    Office line: +86 21 6057 8000

    Investor Inquiries:

    Burns McClellan, Inc. (Americas and Europe)

    Steve Klass

    E-mail:

    Office line: +1 212 213 0006

    The Piacente Group, Inc. (Asia)

    Emilie Wu

    E-mail:

    Office line: +86 21 6039 8363

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/i-mab-receives-china-cde-approval-to-initiate-phase-3-clinical-trial-of-eftansomatropin-in-pediatric-patients-with-growth-hormone-deficiency-301141909.html

    SOURCE I-Mab

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  32. SHANGHAI and GAITHERSBURG, Md., Sept. 21, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has cleared the Investigational New Drug (IND) application for lemzoparlimab (also known as TJC4) to initiate a phase 1 clinical trial in patients with relapsed or refractory advanced lymphoma (CXSL2000206) as part of an ongoing IMCT being conducted also in the U.S. Additionally, a phase 1/2a clinical trial in patients with relapsed or refractory acute myeloid leukemia (r/r AML) in China (CXSL1900039; NCT04202003…

    SHANGHAI and GAITHERSBURG, Md., Sept. 21, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has cleared the Investigational New Drug (IND) application for lemzoparlimab (also known as TJC4) to initiate a phase 1 clinical trial in patients with relapsed or refractory advanced lymphoma (CXSL2000206) as part of an ongoing IMCT being conducted also in the U.S. Additionally, a phase 1/2a clinical trial in patients with relapsed or refractory acute myeloid leukemia (r/r AML) in China (CXSL1900039; NCT04202003;) is currently underway with clinical results expected in early 2021.

    Lemzoparlimab is a highly differentiated anti-CD47 monoclonal antibody originally discovered and developed by I-Mab. It is designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity, a critical attribute in potentially differentiating lemzoparlimab from other antibodies of the same class currently in development.

    The preliminary results of the recent phase 1 clinical trial in the U.S. have shown differentiation of lemzoparlimab in terms of safety and pharmacokinetics profiles in cancer patients. Lemzoparlimab was well tolerated as a single agent at a dose up to 30 mg/kg/week without introducing any priming dose strategy. In all DLT-evaluable patients, no dose-limiting toxicities or severe hematologic adverse events were observed. Full data will be presented at an appropriate scientific conference later this year. At the same time, combination therapy of lemzoparlimab with pembrolizumab in patients with solid tumors and classical Hodgkin's lymphoma are also ongoing in the U.S.

    "We strongly believe that lemzoparlimab has the potential to make a significant difference in the treatment of multiple cancers, particularly hematologic malignancies in China," said Dr. Joan Shen, CEO of I-Mab. "We look forward to accelerating this program through close collaboration between the U.S. and China teams and delivering a potentially life-changing medicine to patients in need."

    Earlier this month, I-Mab entered into a global strategic partnership with AbbVie to develop and commercialize lemzoparlimab. Both companies will collaborate to design and conduct further global clinical trials to evaluate lemzoparlimab in multiple cancers. I-Mab retains all rights to develop and commercialize lemzoparlimab in mainland China, Macau and Hong Kong. The collaboration also allows for potential collaboration on future CD47-related therapeutic agents.

    About CD47 and Lemzoparlimab

    CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don't eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells, making it a potentially promising cancer drug. However, development of CD47 antibody as a cancer therapy is hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. In a scientific breakthrough, scientists at I-Mab have discovered a unique CD47 antibody, lemzoparlimab, that works efficiently to target tumor cells while exerting a minimal untoward effect on red blood cells to avoid severe anemia. 

    Lemzoparlimab's hematologic safety advantage and superb anti-tumor activities have been demonstrated previously in a series of robust pre-clinical studies. The results of phase 1 clinical trial have provided further clinical validation of this differentiation in patients with cancer. I-Mab continues to advance a combination study of lemzoparlimab with Keytruda® for solid tumor and with Rituxan® for lymphoma in the U.S., in addition to an on-going clinical trial in patients with AML in China.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon commercialization of novel or highly differentiated biologics in immuno-oncology. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hong Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the lemzoparlimab (TJC4) Phase 1 trial, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones and commercialization of lemzoparlimab (TJC4). Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, CFO

    E-mail:

    Office line: +86 21 6057 8000

    Gigi Feng, Vice President and Global Head of Corporate Communications

    Email:

    Office line: +86 21 6057 8000

    Investor Inquiries:

    Burns McClellan, Inc. (Americas and Europe)

    Steve Klass

    E-mail:

    Office line: +1 212 213 0006

    The Piacente Group, Inc. (Asia)

    Emilie Wu

    E-mail:

    Office line: +86 21 6039 8363

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/i-mab-announces-china-nmpa-clearance-for-phase-1-clinical-trial-of-lemzoparlimab-in-relapsed-or-refractory-advanced-lymphoma-301134587.html

    SOURCE I-Mab

    View Full Article Hide Full Article
  33. Phase 1 Clinical Study Expected to Start in Q4 2020

    PLANEGG & MUNICH GERMANY AND SHANGHAI, CHINA / ACCESSWIRE / September 17, 2020 / MorphoSys AG (FSE:MOR)(Prime Standard Segment, MDAX & TecDAX; (NASDAQ: MOR) and I-Mab (NASDAQ:IMAB) today jointly announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) for MorphoSys' investigational human anti-C5aR1 antibody MOR210/TJ210 for the treatment of relapsed or refractory advanced solid tumors. The phase 1 clinical trial, designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MOR210/TJ210, may proceed and is expected to commence subsequently.

    MOR210/TJ210 is a highly differentiated monoclonal antibody that is…

    Phase 1 Clinical Study Expected to Start in Q4 2020

    PLANEGG & MUNICH GERMANY AND SHANGHAI, CHINA / ACCESSWIRE / September 17, 2020 / MorphoSys AG (FSE:MOR)(Prime Standard Segment, MDAX & TecDAX; (NASDAQ: MOR) and I-Mab (NASDAQ:IMAB) today jointly announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) for MorphoSys' investigational human anti-C5aR1 antibody MOR210/TJ210 for the treatment of relapsed or refractory advanced solid tumors. The phase 1 clinical trial, designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MOR210/TJ210, may proceed and is expected to commence subsequently.

    MOR210/TJ210 is a highly differentiated monoclonal antibody that is directed against complement factor C5a receptor 1 (C5aR1). Tumor and stromal cells produce C5a that attracts immunosuppressive cell types such as myeloid-derived suppressor cells (MDSCs), M2 macrophages and neutrophils through C5aR1 expressed on their surface, contributing to a hostile tumor microenvironment towards T cells. MOR210/TJ210 is thought to block the interaction between C5a and C5aR1 by binding to C5aR1 and retard the migration of suppressor cells. It has been shown to exert strong anti-tumor activity in combination with immune checkpoint inhibitors in preclinical studies.

    "MOR210/TJ210 has demonstrated encouraging results in preclinical studies. We look forward to progressing MOR210/TJ210 into clinical studies which will enable us to characterize the safety and tolerability of MOR210/TJ210, as well as its potential clinical benefits in patients with cancers", said Dr Joan Shen, Chief Executive Officer of I-Mab.

    "The FDA clearance of the IND application to initiate a Phase 1 clinical trial of MOR210/TJ210 is an important step forward in developing a new treatment for patients with advanced cancer", said Dr Malte Peters, Chief Research & Development Officer of MorphoSys. "We look forward to joining forces with I-Mab in developing highly innovative treatments in oncology and are pleased to support our partner during this significant phase."

    MorphoSys and I-Mab entered into an exclusive strategic collaboration and licensing agreement to develop and commercialize MOR210/TJ210 in November 2018. Under the terms of agreement, I-Mab receives exclusive rights to develop and commercialize MOR210/TJ210 in Greater China and South Korea, while MorphoSys retains rights in other parts of the world. With support from MorphoSys, I-Mab will also fund and conduct all global development activities of MOR210/TJ210, including clinical trials in China and the U.S., towards clinical proof-of-concept (PoC) in oncology.

    The two companies are also collaborating on MorphoSys' investigational human CD38 antibody MOR202/TJ202. I-Mab owns the exclusive rights for development and commercialization in mainland China, Taiwan, Hong Kong and Macao and started two registrational trials to evaluate MOR202/TJ202 in patients with relapsed or refractory multiple myeloma in 2019.

    About MOR210/TJ210
    MOR210 is a novel human antibody directed against C5aR derived from MorphoSys' HuCAL Platinum(R) technology. C5aR, the receptor of the complement factor C5a, is investigated as a potential new drug target in the field of immuno-oncology and autoimmune diseases. Tumors have been shown to produce high amounts of C5a, which, by recruiting and activating myeloid-derived suppressor cells (MDSCs), M2 macrophages and neutrophils, is assumed to contribute to an immune-suppressive pro-tumorigenic microenvironment. MOR210/TJ210 is intended to block the interaction between C5a and its receptor, thereby potentially neutralizing the immune suppressive function and enabling immune cells to attack the tumor.

    About MorphoSys
    MorphoSys (FSE:MOR)(NASDAQ:MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In 2017, Tremfya(R), marketed by Janssen for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of the company's proprietary product Monjuvi(R) (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma. Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees.
    More information at www.morphosys.com or MorphoSys-US.com.

    Monjuvi(R) is a registered trademark of MorphoSys AG.
    Tremfya(R) is a registered trademark of Janssen Biotech.

    About I-Mab
    I-Mab (NASDAQ:IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hong Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com

    MorphoSys Forward-Looking Statements
    This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding the further clinical development of MOR210/TJ210, interactions with regulatory authorities and expectations regarding regulatory filings and possible approvals for MOR210/TJ210 as well as the potential future commercialization of MOR210/TJ210. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would," "could," "potential," "possible," "hope" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are MorphoSys' expectations regarding risks and uncertainties related to the impact of the COVID-19 pandemic to MorphoSys' business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products, the global collaboration and license agreement for MOR210/TJ210, the further clinical development of MOR210/TJ210, and MorphoSys' ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings , MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

    I-Mab Forward-Looking Statements
    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the TJ210/MOR210 Phase 1 trial of advanced cancers, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones and commercialization of TJ210/MOR210. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    For more information, please contact:

    MorphoSys
    Media Contacts:
    Jeanette Bressi
    Director, US Communications
    Tel: +1 617-404-7816

    Sophie Petersen
    Senior Specialist
    Tel: +49 (0)89 899 27 26033

    Investor Contacts:
    Dr. Anja Pomrehn
    Senior Vice President
    Tel: +49 (0)89 / 899 27 26972

    Dr. Julia Neugebauer
    Director
    Tel: +49 (0)89 / 899 27 179

    I-Mab
    Media Contacts:
    Gigi Feng
    Vice President and Global Head of Corporate Communications
    Tel: +86 21 6057 8000

    Investor Contacts:
    Jielun Zhu
    Chief Financial Officer
    Tel: +86 21 6057 8000

    SOURCE: MorphoSys AG via EQS Newswire



    View source version on accesswire.com:
    https://www.accesswire.com/606632/MorphoSys-and-I-Mab-Announce-FDA-Clearance-of-IND-Application-for-MOR210TJ210-in-Patients-with-Advanced-Cancer

    View Full Article Hide Full Article
  34. PLANEGG/MUNICH, Germany and SHANGHAI, China, Sept. 17, 2020 /PRNewswire/ -- MorphoSys AG ((FSE: MOR, Prime Standard Segment, MDAX &amp, TecDAX, NASDAQ:MOR) and I-Mab (NASDAQ:IMAB) today jointly announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) for MorphoSys' investigational human anti-C5aR1 antibody MOR210/TJ210 for the treatment of relapsed or refractory advanced solid tumors. The phase 1 clinical trial, designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MOR210/TJ210, may proceed and is expected to commence subsequently. 

    MOR210/TJ210 is a highly differentiated monoclonal antibody that is directed against complement factor C5a receptor 1…

    PLANEGG/MUNICH, Germany and SHANGHAI, China, Sept. 17, 2020 /PRNewswire/ -- MorphoSys AG ((FSE: MOR, Prime Standard Segment, MDAX &, TecDAX, NASDAQ:MOR) and I-Mab (NASDAQ:IMAB) today jointly announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) for MorphoSys' investigational human anti-C5aR1 antibody MOR210/TJ210 for the treatment of relapsed or refractory advanced solid tumors. The phase 1 clinical trial, designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MOR210/TJ210, may proceed and is expected to commence subsequently. 

    MOR210/TJ210 is a highly differentiated monoclonal antibody that is directed against complement factor C5a receptor 1 (C5aR1). Tumor and stromal cells produce C5a that attracts immunosuppressive cell types such as myeloid-derived suppressor cells (MDSCs), M2 macrophages and neutrophils through C5aR1 expressed on their surface, contributing to a hostile tumor microenvironment towards T cells. MOR210/TJ210 is thought to block the interaction between C5a and C5aR1 by binding to C5aR1 and retard the migration of suppressor cells. It has been shown to exert strong anti-tumor activity in combination with immune checkpoint inhibitors in preclinical studies.

    "MOR210/TJ210 has demonstrated encouraging results in preclinical studies. We look forward to progressing MOR210/TJ210 into clinical studies which will enable us to characterize the safety and tolerability of MOR210/TJ210, as well as its potential clinical benefits in patients with cancers", said Dr Joan Shen, Chief Executive Officer of I-Mab.

    "The FDA clearance of the IND application to initiate a Phase 1 clinical trial of MOR210/TJ210 is an important step forward in developing a new treatment for patients with advanced cancer", said Dr Malte Peters, Chief Research & Development Officer of MorphoSys. "We look forward to joining forces with I-Mab in developing highly innovative treatments in oncology and are pleased to support our partner during this significant phase."

    MorphoSys and I-Mab entered into an exclusive strategic collaboration and licensing agreement to develop and commercialize MOR210/TJ210 in November 2018. Under the terms of agreement, I-Mab receives exclusive rights to develop and commercialize MOR210/TJ210 in Greater China and South Korea, while MorphoSys retains rights in other parts of the world. With support from MorphoSys, I-Mab will also fund and conduct all global development activities of MOR210/TJ210, including clinical trials in China and the U.S., towards clinical proof-of-concept (PoC) in oncology.

    The two companies are also collaborating on MorphoSys' investigational human CD38 antibody MOR202/TJ202. I-Mab owns the exclusive rights for development and commercialization in mainland China, Taiwan, Hong Kong and Macao and started two registrational trials to evaluate MOR202/TJ202 in patients with relapsed or refractory multiple myeloma in 2019.

    About MOR210/TJ210

    MOR210 is a novel human antibody directed against C5aR derived from MorphoSys's HuCAL Platinum® technology. C5aR, the receptor of the complement factor C5a, is investigated as a potential new drug target in the field of immuno-oncology and autoimmune diseases. Tumors have been shown to produce high amounts of C5a, which, by recruiting and activating myeloid-derived suppressor cells (MDSCs), M2 macrophages and neutrophils, is assumed to contribute to an immune-suppressive pro-tumorigenic microenvironment. MOR210/TJ210 is intended to block the interaction between C5a and its receptor, thereby potentially neutralizing the immune suppressive function and enabling immune cells to attack the tumor.

    About MorphoSys

    MorphoSys ((FSE &, NASDAQ:MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In 2017, Tremfya®, marketed by Janssen for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of the company's proprietary product Monjuvi® (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma. Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees.

    More information at www.morphosys.com or MorphoSys-US.com.

    Monjuvi® is a registered trademark of MorphoSys AG.

    Tremfya® is a registered trademark of Janssen Biotech.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hong Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com

    MorphoSys Forward-Looking Statements

    This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding the further clinical development of MOR210/TJ210, interactions with regulatory authorities and expectations regarding regulatory filings and possible approvals for MOR210/TJ210 as well as the potential future commercialization of MOR210/TJ210. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would," "could," "potential," "possible," "hope" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are MorphoSys' expectations regarding risks and uncertainties related to the impact of the COVID-19 pandemic to MorphoSys' business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products, the global collaboration and license agreement for MOR210/TJ210, the further clinical development of MOR210/TJ210, and MorphoSys' ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings , MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

    I-Mab Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the TJ210/MOR210 Phase 1 trial of advanced cancers, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones and commercialization of TJ210/MOR210. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    For more information, please contact:

    MorphoSys

    Media Contacts:

    Jeanette Bressi

    Director, US Communications

    Tel: +1 617-404-7816

     

    Investor Contacts:

    Dr. Anja Pomrehn

    Senior Vice President

    Tel: +49 (0)89 / 899 27 26972

     

     

     

    Sophie Petersen

    Senior Specialist

    Tel: +49 (0)89 899 27 26033

     

     

    Dr. Julia Neugebauer

    Director

    Tel: +49 (0)89 / 899 27 179

     

     

    I-Mab



    Media Contacts:

    Gigi Feng

    Vice President and Global Head of Corporate Communications

    Tel: +86 21 6057 8000

     

    Investor Contacts:

    Jielun Zhu

    Chief Financial Officer

    Tel: +86 21 6057 8000

     







     

    Cision View original content:http://www.prnewswire.com/news-releases/morphosys-and-i-mab-announce-fda-clearance-of-ind-application-for-mor210tj210-in-patients-with-advanced-cancer-301133574.html

    SOURCE I-Mab

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  35. SHANGHAI and GAITHERSBURG, Md., Sept. 8, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced its participation in the following conferences in September. Details of the conferences and management presentations are as follows:

    Cantor Fitzgerald Virtual Global Healthcare Conference 2020

    Presentation: Tuesday, September 15, 2020 at 8:00-8:30 a.m. ET

    Presenters: Dr. Jingwu Zang, Founder, Honorary Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Ms. Leah Liu, Senior IR Director

    Webcast link: https://www.webcaster4.com/Webcast/Page/2495/37179

    The webcast will also be available under "Event Calendar" on IMAB's IR website at https://ir.i-mabbiopharma.com/

    One-on-one meetings: September 15-17, 2020

    For more information, please contact your Cantor Fitzgerald representative.

    Jefferies Virtual Asia Forum

    Presentation: Wednesday, September 16, 2020 at 4:00-4:50 a.m. ET

    Presenters: Dr. Jingwu Zang, Founder, Honorary Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Ms. Leah Liu, Senior IR Director

    One-on-one and small group meetings: September 14-16, 2020

    For more information, please contact your Jefferies representative.

    ICBCI Virtual ADR New Economy Conference

    Management participants: Dr. Jingwu Zang, Founder, Honorary Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Ms. Leah Liu, Senior IR Director

    One-on-one and small group meetings: September 18, 2020

    For more information, please contact your ICBCI representative.

    2020 Huatai USA Autumn Virtual China Conference

    Management participants: Dr. Jingwu Zang, Founder, Honorary Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Ms. Leah Liu, Senior IR Director

    One-on-one and small group meetings: September 21-23, 2020

    For more information, please contact your Huatai representative.

    Morgan Stanley Virtual Asia Pacific Conference

    Management participants: Dr. Jingwu Zang, Founder, Honorary Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Ms. Leah Liu, Senior IR Director

    One-on-one and small group meetings: September 24-25, 2020

    For more information, please contact your Morgan Stanley representative.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hong Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com

    For more information, please contact:

    I-Mab

    Jielun Zhu, CFO

    E-mail:

    Office line: +86 21 6057 8000

    Gigi Feng, Vice President and Global Head of Corporate Communications

    E-mail:

    Office line: +86 21 6057 8000

    Investor Inquiries:

    Burns McClellan, Inc. (Americas and Europe)

    Steve Klass

    E-mail:

    Office line: +1 212 213 0006

    The Piacente Group, Inc. (Asia)

    Emilie Wu

    E-mail:

    Office line: +86 21 6039 8363

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/i-mab-announces-upcoming-participation-at-september-conferences-301125446.html

    SOURCE I-Mab

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  36. SHANGHAI and GAITHERSBURG, Md., Sept. 4, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that it has entered into definitive subscription agreements with a consortium of institutional investors (the "Investors") to raise approximately US$418 million through a private placement. The consortium is led by Hillhouse Capital Group ("Hillhouse"), with significant participation by GIC, and also includes certain other leading Asian and U.S. biotech investment funds, such as Avidity Partners, OrbiMed, Octagon Capital Advisors, Invus, Lake Bleu Capital, Perceptive Advisors, Cormorant Asset Management, Sphera…

    SHANGHAI and GAITHERSBURG, Md., Sept. 4, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that it has entered into definitive subscription agreements with a consortium of institutional investors (the "Investors") to raise approximately US$418 million through a private placement. The consortium is led by Hillhouse Capital Group ("Hillhouse"), with significant participation by GIC, and also includes certain other leading Asian and U.S. biotech investment funds, such as Avidity Partners, OrbiMed, Octagon Capital Advisors, Invus, Lake Bleu Capital, Perceptive Advisors, Cormorant Asset Management, Sphera Healthcare and Alyeska Investment Group, L.P. Hillhouse is entitled to nominate one representative to I-Mab's Board of Directors.

    The private placement comprises (1) the sale to the Investors of approximately US$418 million of the Company's 29,133,502 ordinary shares (the "Ordinary Shares") (equivalent to 12,666,740 American Depositary Shares ("ADSs") at a purchase price equivalent to US$33 per ADS, representing a 2.9% premium to the 30-day VWAP; and (2) warrants (the "Warrants") to subscribe for an aggregate of 5,341,267 Ordinary Shares (equivalent to 2,322,290 ADSs) at an exercise price equivalent to US$45 per ADS, representing a 40.3% premium to the 30-day VWAP, which may further increase the proceeds of approximately US$104.5 million if the Warrants are fully exercised. The Warrants will remain exercisable at the election of the Investors within 12 months after the closing of the private placement.

    The Company will receive all proceeds from the private placement and intends to utilize them to fund the ongoing and planned research and clinical programs globally as well as the development of its commercialization capabilities in China.

    "We are honored to have the support of such a distinguished group of globally renowned investors. This financing, which is among one of the largest PIPE deals in recent history, will strengthen our position to effectively execute our strategic priorities and advance our globally competitive pipeline to ultimately bring innovative medicines to patients in need," said Dr. Jingwu Zang, Founder, Honorary Chairman and Director of I-Mab. "We are very pleased to welcome Hillhouse to our Board and look forward to its counsel on our journey to become a fully integrated biopharma."

    Mr. Michael Yi, Co-CIO of Hillhouse, said, "Our latest investment in I-Mab is a perfect example of Hillhouse's long-term commitment to funding pioneering innovation in life sciences. We see in I-Mab the same qualities that have propelled other biotech companies to success: clear scientific vision, unswerving focus on innovation and flawless execution. We are delighted to partner with an industry leader like I-Mab to scale new heights in its quest for truly transformative therapies."

    Choo Yong Cheen, Chief Investment Officer of Private Equity, GIC, said, "Our recent investment represents the strengthening of our partnership with I-MAB. As a long-term investor, GIC invests throughout a company's various stages of development and we have been impressed by I-MAB's steadfast resolve on innovation and achievements since inception."

    The securities sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction's securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions' securities laws. The Company has agreed to file registration statements with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the Ordinary Shares issuable in connection with this private placement, including upon exercise of the Warrants.

    Jefferies LLC is acting as lead placement agent for the private placement. China Renaissance also participated as a financial advisor.

    On the same date, the Company announces that it has entered into a global partnership agreement for the development and commercialization of lemzoparlimab (also known as TJC4), an innovative anti-CD47 monoclonal antibody internally discovered and developed by I-Mab for the treatment of cancers. In addition, the two partners will collaborate on additional transformative CD47-based bispecific antibodies as well as combination therapies. 

    I-Mab Conference Call and Webcast Information

    Investors and analysts are invited to join the conference call today at 8:00 a.m. ET using the following dial-in information:

    United States:   +1-888-346-8982

    International:     +1-412-902-4272

    Mainland China: 400-120-1203

    Hong Kong:        800-905-945

    Conference ID:   10147681

    A live webcast and an archived replay of the conference call can be accessed on the Company's investor relations website at http://ir.i-mabbiopharma.com.

    A telephone replay will be available approximately two hours after the conclusion of the call by dialing +1-877-344-7529 (U.S.), 1-412-317-0088 (International). The conference ID number for the replay is 10147681. The replay will be available through September 11, 2020.

    About I-MAB

    I-Mab (NASDAQ:IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon commercialization of novel or highly differentiated biologics in immuno-oncology. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hong Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com

    Safe Harbor Statements

    The Company cautions its shareholders and others considering trading its securities that there can be no assurance that the transactions contemplated under the Subscription Agreements will be consummated. This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995 and other federal securities laws, as amended. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "aims," "future," "intends," "plans," "believes," "estimates," "likely to" and similar statements. Statements that are not historical facts, including statements about I-Mab's beliefs, plans and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. Further information regarding these and other risks is included in I-Mab's filings with the SEC. All information provided in this press release is as of the date of this press release, and I-Mab does not undertake any obligation to publicly update or revise any forward-looking statement, except as required under applicable law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, CFO

    E-mail: 

    Office line: +86 21 6057 8000

    Gigi Feng, Vice President and Global Head of Corporate Communications

    Email: 

    Office line: +86 21 6057 8000

    Investor Inquiries:

    Burns McClellan, Inc. (Americas and Europe)

    Steve Klass

    E-mail: 

    Office line: +1 212 213 0006

    The Piacente Group, Inc. (Asia)

    Emilie Wu

    E-mail: 

    Office line: +86 21 6039 8363

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  37. NORTH CHICAGO, Ill., and SHANGHAI, Sept. 4, 2020 /PRNewswire/ -- AbbVie (NYSE:ABBV) and I-Mab (NASDAQ:IMAB) announced today that AbbVie and I-Mab have signed a broad, global collaboration agreement for the development and commercialization of lemzoparlimab (also known as TJC4), an innovative anti-CD47 monoclonal antibody internally discovered and developed by I-Mab for the treatment of multiple cancers. In addition, the two partners have the potential to expand the collaboration to additional transformative therapies. 

    Lemzoparlimab is one of the leading drug candidates among I-Mab's proprietary and innovative pipeline. It is designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity, a critical…

    NORTH CHICAGO, Ill., and SHANGHAI, Sept. 4, 2020 /PRNewswire/ -- AbbVie (NYSE:ABBV) and I-Mab (NASDAQ:IMAB) announced today that AbbVie and I-Mab have signed a broad, global collaboration agreement for the development and commercialization of lemzoparlimab (also known as TJC4), an innovative anti-CD47 monoclonal antibody internally discovered and developed by I-Mab for the treatment of multiple cancers. In addition, the two partners have the potential to expand the collaboration to additional transformative therapies. 

    Lemzoparlimab is one of the leading drug candidates among I-Mab's proprietary and innovative pipeline. It is designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity, a critical attribute in potentially differentiating lemzoparlimab from other antibodies of the same class currently in development. Topline results of the recent phase 1 clinical trial confirm possible differentiation of lemzoparlimab in drug safety and a more favorable pharmacokinetics profile in cancer patients. Results have shown that lemzoparlimab is well tolerated as a single agent at a dose range of up to 30 mg/kg without any priming dose. In all DLT-evaluable patients, no dose-limiting toxicities or severe hematologic adverse events were observed. Full data will be presented at an appropriate scientific conference later this year.

    "Cancer is the second-leading cause of death globally and the need for novel cancer therapies has never been more acute. The addition of I-Mab's novel CD47 programs complements our global clinical strategy in hematology and immuno-oncology," said Thomas J. Hudson, M.D., senior vice president of R&D and chief scientific officer, AbbVie. "We have been impressed with what I-Mab has been able to accomplish in research and clinical development and we look forward to working together to make a meaningful difference in the lives of millions of patients globally."

    "At the forefront of drug innovation, our goal at I-Mab has always been to bring transformational therapies to patients globally. This strategic collaboration reinforces I-Mab's leading position in immuno-oncology and enables us to realize the full potential of our innovation," said Jingwu Zang, M.D., Ph.D., Founder, Honorary Chairman and Director of I-Mab. "We are extremely proud to partner with AbbVie. By leveraging the combined development strength of our companies, we aim to speed lemzoparlimab to market for patients in need around the world."

    Collaboration Details

    The collaboration established today provides AbbVie with an exclusive global license, excluding greater China, to develop and commercialize lemzoparlimab. Both companies will collaborate to design and conduct further global clinical trials to evaluate lemzoparlimab in multiple cancers. I-Mab retains all rights to develop and to commercialize lemzoparlimab in mainland China, Macau and Hong Kong. The collaboration also allows for potential collaboration on future CD47-related therapeutic agents. Each party will have the opportunity subject to further licenses to explore each other's related programs in their respective territories.

    The companies will share manufacturing responsibilities with AbbVie being the primary manufacturer for global supply. The collaboration will accelerate I-Mab's establishment of commercial production operations in China.

    Financial Terms

    Under the terms of the agreement, AbbVie will pay I-Mab $180 million in an upfront payment to exclusively license lemzoparlimab, along with $20 million in a milestone payment based on the Phase 1 results, for a total of $200 million. In addition, I-Mab will be eligible to receive up to $1.74 billion in success-based milestone payments for lemzoparlimab, of which $840 million are based on clinical development and regulatory approval milestones, with the remainder based on commercial milestones. Upon commercialization of lemzoparlimab, AbbVie will also pay tiered royalties from low-to-mid teen percentages on global net sales outside of greater China.   

    Conference Call

    I-Mab will hold a conference call in English today, September 4, 2020, at 8:00 a.m. ET / 8:00 p.m. CST. The dial in numbers are:

    United States:   +1-888-346-8982

    International:     +1-412-902-4272

    Mainland China: 400-120-1203

    Hong Kong:          800-905-945

    Conference ID:  10147681

    A live webcast and an archived replay of the conference call can be accessed on the Company's investor relations website at http://ir.i-mabbiopharma.com.

    A telephone replay will be available approximately two hours after the conclusion of the call by dialing +1-877-344-7529 (U.S.), 1-412-317-0088 (International). The conference ID number for the replay is 10147681. The replay will be available through September 9, 2020.

    About CD47 and Lemzoparlimab

    CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don't eat me" signal to otherwise tumor-engulfing macrophages.  CD47 antibody blocks this signal and enables macrophages to attack tumor cells, making it a potentially promising cancer drug. However, development of CD47 antibody as a cancer therapy is hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. In a scientific breakthrough, scientists at I-Mab have discovered a unique CD47 antibody, lemzoparlimab, that works efficiently to target tumor cells while exerting a minimal untoward effect on red blood cells to avoid severe anemia.

    Lemzoparlimab's hematologic safety advantage and superb anti-tumor activities have been demonstrated previously in a series of robust pre-clinical studies. Today, the results of phase 1 clinical trial provide further clinical validation of this differentiation in patients with cancer. I-Mab continues to advance a combination study of lemzoparlimab with Keytruda® for solid tumor and with Rituxan® for lymphoma in US, in addition to an on-going clinical trial in patients with AML in China.

    About AbbVie

    AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hong Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com

    Forward Looking Statements for AbbVie

    Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

    Forward Looking Statements for I-Mab

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the lemzoparlimab (TJC4) Phase I trial, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones and commercialization of lemzoparlimab (TJC4). Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    Cision View original content:http://www.prnewswire.com/news-releases/abbvie-and-i-mab-enter-into-global-strategic-partnership-for-differentiated-immuno-oncology-therapy-301124325.html

    SOURCE AbbVie

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  38. NORTH CHICAGO, Illinois and SHANGHAI, China, Sept. 4, 2020 /PRNewswire/ -- AbbVie (NYSE:ABBV) and I-Mab (NASDAQ:IMAB) announced today that AbbVie and I-Mab have signed a broad, global collaboration agreement for the development and commercialization of lemzoparlimab (also known as TJC4), an innovative anti-CD47 monoclonal antibody internally discovered and developed by I-Mab for the treatment of multiple cancers. In addition, the two partners have the potential to expand the collaboration to additional transformative therapies. 

    Lemzoparlimab is one of the leading drug candidates among I-Mab's proprietary and innovative pipeline. It is designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity, a critical attribute in potentially differentiating lemzoparlimab from other antibodies of the same class currently in development. Topline results of the recent phase 1 clinical trial confirm possible differentiation of lemzoparlimab in drug safety and a more favorable pharmacokinetics profile in cancer patients. Results have shown that lemzoparlimab is well tolerated as a single agent at a dose range of up to 30 mg/kg without any priming dose. In all DLT-evaluable patients, no dose-limiting toxicities or severe hematologic adverse events were observed. Full data will be presented at an appropriate scientific conference later this year.

    "At the forefront of drug innovation, our goal at I-Mab has always been to bring transformational therapies to patients globally. This strategic collaboration reinforces I-Mab's leading position in immuno-oncology and enables us to realize the full potential of our innovation," said Jingwu Zang, M.D., Ph.D., Founder, Honorary Chairman and Director of I-Mab. "We are extremely proud to partner with AbbVie. By leveraging the combined development strength of our companies, we aim to speed lemzoparlimab to market for patients in need around the world."

    "Cancer is the second-leading cause of death globally and the need for novel cancer therapies has never been more acute. The addition of I-Mab's novel CD47 programs complements our global clinical strategy in hematology and immuno-oncology," said Thomas J. Hudson, M.D., senior vice president of R&D and chief scientific officer, AbbVie. "We have been impressed with what I-Mab has been able to accomplish in research and clinical development and we look forward to working together to make a meaningful difference in the lives of millions of patients globally."

    Collaboration Details

    The collaboration established today provides AbbVie with an exclusive global license, excluding greater China, to develop and commercialize lemzoparlimab. Both companies will collaborate to design and conduct further global clinical trials to evaluate lemzoparlimab in multiple cancers. I-Mab retains all rights to develop and to commercialize lemzoparlimab in mainland China, Macau and Hong Kong. The collaboration also allows for potential collaboration on future CD47-related therapeutic agents. Each party will have the opportunity subject to further licenses to explore each other's related programs in their respective territories.

    The companies will share manufacturing responsibilities with AbbVie being the primary manufacturer for global supply. The collaboration will accelerate I-Mab's establishment of commercial production operations in China.

    Financial Terms

    Under the terms of the agreement, AbbVie will pay I-Mab USD 180 million in an upfront payment to exclusively license lemzoparlimab, along with USD 20 million in a milestone payment based on the phase 1 results, for a total of USD 200 million. In addition, I-Mab will be eligible to receive up to USD 1.74 billion in success-based milestone payments for lemzoparlimab, of which USD 840 million are based on clinical development and regulatory approval milestones, with the remainder based on commercial milestones. Upon commercialization of lemzoparlimab, AbbVie will also pay tiered royalties from low-to-mid teen percentages on global net sales outside of greater China.   

    Conference Call

    I-Mab will hold a conference call in English today, September 4, 2020, at 8:00 a.m. ET / 8:00 p.m. CST. The dial in numbers are:

    United States:

    +1-888-346-8982

    International: 

    +1-412-902-4272

    Mainland China:

    400-120-1203

    Hong Kong:

    800-905-945

    Conference ID: 

    10147681

    A live webcast and an archived replay of the conference call can be accessed on the Company's investor relations website at http://ir.i-mabbiopharma.com.

    A telephone replay will be available approximately two hours after the conclusion of the call by dialing +1-877-344-7529 (U.S.), 1-412-317-0088 (International). The conference ID number for the replay is 10147681. The replay will be available through September 11, 2020.

    About CD47 and Lemzoparlimab

    CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don't eat me" signal to otherwise tumor-engulfing macrophages.  CD47 antibody blocks this signal and enables macrophages to attack tumor cells, making it a potentially promising cancer drug. However, development of CD47 antibody as a cancer therapy is hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. In a scientific breakthrough, scientists at I-Mab have discovered a unique CD47 antibody, lemzoparlimab, that works efficiently to target tumor cells while exerting a minimal untoward effect on red blood cells to avoid severe anemia. 

    Lemzoparlimab's hematologic safety advantage and superb anti-tumor activities have been demonstrated previously in a series of robust pre-clinical studies. Today, the results of phase 1 clinical trial provide further clinical validation of this differentiation in patients with cancer. I-Mab continues to advance a combination study of lemzoparlimab with Keytruda® for solid tumor and with Rituxan® for lymphoma in US, in addition to an on-going clinical trial in patients with AML in China.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hong Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com

    About AbbVie

    AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

    Forward Looking Statements for I-Mab

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the lemzoparlimab (TJC4) Phase I trial, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones and commercialization of lemzoparlimab (TJC4). Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    Forward Looking Statements for AbbVie

    Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe,""expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

     

    AbbVie Contacts

    I-Mab Contacts

    Media:



    Adelle Infante

    Gigi Feng, Vice President and Global Head of

    Corporate Communications

    (847) 938-8745

    +86 21 6057 8000





    Investors:



    Liz Shea

    Jielun Zhu, CFO

    (847) 935-2211

    +86 21 6057 8000

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/abbvie-and-i-mab-enter-into-global-strategic-partnership-for-differentiated-immuno-oncology-therapy-301124424.html

    SOURCE I-Mab

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  39. Positive preliminary clinical trial results for lemzoparlimab (TJC4) demonstrate a differentiated drug profile in safety and pharmacokinetics in cancer patients

    Joined the global effort against COVID-19 with plonmarlimab (TJM2) study which represents the first double-blind, placebo-controlled study evaluating anti-GM-CSF antibody in severe COVID-19 patients    

    The Company expects significant pipeline updates in H2 2020 including China registrational trial with CD38 antibody felzartamab (TJ202) as third-line monotherapy for multiple myeloma; the Company also expects IND approval for eftansomatropin (TJ101), a unique long acting growth hormone in the fourth quarter of 2020 and to initiate phase 3 study subsequently

    The Company to host conference

    Positive preliminary clinical trial results for lemzoparlimab (TJC4) demonstrate a differentiated drug profile in safety and pharmacokinetics in cancer patients

    Joined the global effort against COVID-19 with plonmarlimab (TJM2) study which represents the first double-blind, placebo-controlled study evaluating anti-GM-CSF antibody in severe COVID-19 patients    

    The Company expects significant pipeline updates in H2 2020 including China registrational trial with CD38 antibody felzartamab (TJ202) as third-line monotherapy for multiple myeloma; the Company also expects IND approval for eftansomatropin (TJ101), a unique long acting growth hormone in the fourth quarter of 2020 and to initiate phase 3 study subsequently

    The Company to host conference call and webcast on August 31 at 8:00 a.m. ET

    SHANGHAI and GAITHERSBURG, Md., Aug. 31, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced financial results for the six months ended June 30, 2020 and provided an overview of recent highlights and upcoming milestones.

    "I-Mab continues to advance our robust pipeline, create value through innovation, and is well positioned to become a fully integrated global biopharmaceutical company. The differentiation of our innovative assets has become validated as the clinical trials progress, as exemplified by our positive preliminary clinical results for lemzoparlimab," said Dr. Jingwu Zang, Founder, Honorary Chairman and Director of I-Mab. "Looking ahead, we remain excited and confident in our science and increasing capabilities to deliver the promised corporate and pipeline development milestones and create value for patients as well as for our shareholders."

    The Company expects multiple data readouts across a progressing pipeline in the coming months. These include the clinical results of phase 1 clinical trial in the U.S. and China for lemzoparlimab, initial data from uliledlimab (TJD5), the differentiated CD73 antibody, Part 2 clinical update from plonmarlimab in patients with cytokine release syndrome associated with severe COVID-19, as well as phase 2 results from olamkicept (TJ301) in patients with ulcerative colitis. Felzartamab (TJ202), the Company's in-licensed CD38 antibody, is being evaluated in two parallel registrational studies in China for the treatment of multiple myeloma and is on track for subject enrollment.

    In addition, the Company's recent appointment of Chief Commercial Officer Ivan Yifei Zhu marks the Company's commitment to building commercial capability and executing our commercialization plans for upcoming product launches. The remarkable progress in pipeline and corporate development demonstrated during this period significantly strengthens the Company's position to achieve longer-term growth into 2021 and beyond.

    Recent Highlights and Upcoming Milestones

    Internally Discovered Global Pipeline

    • TJC4 or lemzoparlimab (differentiated anti-CD47):

      - Clinical development in the U.S.: Lemzoparlimab is one of the leading drug candidates among I-Mab's proprietary and innovative pipeline. It is designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity, a critical attribute in differentiating lemzoparlimab from some other antibodies of the same class currently in development. The topline results of the recently completed phase 1 dose-escalation clinical trial in the U.S. have demonstrated the differentiated profile of lemzoparlimab in drug safety and favorable pharmacokinetics in cancer patients. The results have shown that lemzoparlimab is well tolerated as a single agent at a dose range of up to 30 mg/kg without introducing any priming dosing strategy. In all DLT-evaluable patients, no dose-limiting toxicities or severe hematologic adverse events were observed. Detailed data will be released separately and presented at an appropriate scientific conference later this year. The on-going U.S. study has proceeded into a combination trial with PD-1 inhibitor pembrolizumab (KEYTRUDA®) in cancer patients with several types of solid tumors through a collaboration with Merck Sharp & Dohme Corp (MSD) and Rituximab (RITUXAN®) in patients with Non-Hodgkin's lymphoma (NHL).

      - Clinical development in China: Lemzoparlimab is being evaluated in a Phase 1/2a clinical trial in patients with relapsed or refractory acute myeloid leukemia (r/r AML) or myelodysplastic syndrome (MDS) in China. Results are expected in early 2021.  
    • TJD5 or uliledlimab (differentiated anti-CD73):

      - Clinical development in the U.S.: TJD5 is being evaluated in a Phase 1, dose-escalation clinical trial to examine the safety, tolerability and preliminary efficacy of the combination therapy with atezolizumab (in collaboration with Roche) in patients with advanced solid tumors. The preliminary data are expected in the fourth quarter of 2020.

      - Clinical development in China: TJD5 is on track in a Phase 1 clinical trial to evaluate the safety, tolerability, PK/PD, and potential efficacy primarily in patients with solid tumors, including lung cancer, as a single agent and the combination therapy with a PD-1 (in collaboration with Junshi).
    • TJM2 or plonmarlimab (anti-GM-CSF): 

      - In May 2020, I-Mab announced results from Part 1 of a multi-center, double blinded, randomized, placebo-controlled, three-arm clinical study of TJM2 in patients with cytokine release syndrome (CRS) associated with severe COVID-19. TJM2 is found to be well tolerated in patients with severe COVID-19. 

      - I-Mab is currently conducting Part 2 of the clinical trial to evaluate the efficacy, safety and cytokine levels following a single dose of 6 mg/kg TJM2 or placebo (standard care) in patients with severe COVID-19. The Company is currently in discussion with the FDA to finalize the plan for TJM2 in relation to clinical development and potential registration in the U.S.  

      - I-Mab has recently initiated a multiple-dose Phase 1b study with TJM2 in patients with rheumatoid arthritis (RA) in China.
    • Early-stage pipeline of novel monoclonal antibodies advancing toward clinical development in the U.S. and China:

      - TJ210 is a novel monoclonal antibody directed at C5aR for cancers through a partnership with MorphoSys. I-Mab submitted IND to the U.S. FDA in August and plan to subsequently initiate clinical development in the U.S. upon IND approval. I-Mab also plans to initiate development of TJ210 in China.  

      - In June 2020, I-Mab and ABL Bio presented preclinical data on a newly developed, novel bispecific antibody, TJ-CD4B, at the American Association for Cancer Research (AACR) Virtual Annual Meeting. TJ-CD4B has a duel targeting property combining Claudin 18.2 (a gastric- and pancreatic-specific cancer antigen) and 4-1BB and is uniquely structured to supercharge T cells in a Claudin 18.2-dependent manner, enhancing anti-tumor immunity while potentially minimizing toxicity.

    "Fast to Market" China Portfolio

    • TJ202 or felzartamab (differentiated anti-CD38) for multiple myeloma (MM): 

      - I-Mab is conducting two parallel registrational trials with TJ202 as a third-line monotherapy and as a second line combination therapy with lenalidomide, both in patients with multiple myeloma in Taiwan and mainland China. The trials are ongoing, and recruitment progress remains on track. The Company expects to complete a BLA submission in 2021. 
    • TJ101 or eftansomatropin (differentiated long-acting growth hormone) for pediatric growth hormone deficiency (PGHD): 

      - The China National Medical Products Administration (NMPA) has accepted an IND application for a registrational phase 3 study to assess the efficacy, safety and pharmacokinetics of TJ101 in PGHD. The Company expects to obtain IND approval in the fourth quarter of 2020 and initiate the phase 3 study subsequently.

       
    • TJ107 or efineptakin alfa (long-acting interleukin 7) for glioblastoma multiforme (GBM):

      - Following a phase 1b clinical trial, I-Mab has obtained regulatory clearance from the China NMPA to initiate a phase 2 clinical trial with TJ107 in glioblastoma multiforme patients with lymphopenia in the fourth quarter of 2020.

       
    • TJ301 or olamkicept (differentiated interleukin-6 inhibitor) for ulcerative colitis (UC) and other autoimmune diseases:

      - The phase 2 clinical trial is on-going to enroll remaining patients to assess the pharmacokinetics, safety, and efficacy of TJ301 in patients with active ulcerative colitis. The enrollment is expected to complete in the third quarter of 2020. Topline data is expected to be released by early 2021.

    Corporate

    • In July 2020, I-Mab's Board of Directors authorized a stock repurchase program under which the Company may repurchase up to US$20 million of its ordinary shares in the form of American depositary shares.



    • In July 2020, I-Mab announced its 2020 Share Incentive Plan (the "Plan"), the maximum aggregate number of shares which may be issued pursuant to all awards shall be 10,760,513 Ordinary Shares. The purpose of the Plan is to provide management and staff with ownership-based incentives for achievements of critical corporate and clinical development milestones to generate superior returns to the Company's shareholders.



    • In May 2020, I-Mab expanded its global footprint with the opening of the Company's Hong Kong office, serving as a regional hub for the Company's capital markets and investor relations activities.

    Commercialization Capability

    • In July 2020, I-Mab appointed Mr. Ivan Yifei Zhu as the Company's Chief Commercial Officer. Mr. Zhu has more than 20 years of successful commercialization experience and held senior executive positions at global, domestic pharma and biotech companies. In his new role, Mr. Zhu will focus on building and developing I-Mab's commercialization infrastructure and strategies and preparing the Company for upcoming product launches.

    First Half 2020 Financial Results

    Cash Position

    As of June 30, 2020, the Company had cash, cash equivalents, restricted cash and short-term investments of RMB1.6 billion (US$221.1 million), compared with RMB1.2 billion as of December 31, 2019.

    Net Revenues

    Total net revenues for the six months ended June 30, 2020 were nil, compared with RMB15.0 million for the six months ended June 30, 2019.

    Research & Development Expenses

    Research and development expenses for the six months ended June 30, 2020 were RMB442.3 million (US$62.6 million), compared with RMB265.1 million for the six months ended June 30, 2019. The increase was primarily due to increases in CRO service fees to advance the Company's pipelines, higher share-based compensation, and higher employee salary and benefits expenses due to increased research and development headcount.

    Administrative Expenses

    Administrative expenses for the six months ended June 30, 2020 were RMB171.4 million (US$24.3 million), compared with RMB574.6 million for the six months ended June 30, 2019. The decrease was primarily due to reduced share-based compensation expenses of RMB268.9 million (US$38.1 million).

    Net Loss

    Net loss for the six months ended June 30, 2020 was RMB582.9 million (US$82.5 million), compared with RMB857.3 million for the six months ended June 30, 2019. Net loss per share attributable to ordinary shareholders for the six months ended June 30, 2020 was RMB4.78 (US$0.68), compared with RMB119.34 for the six months ended June 30, 2019.

    Non-GAAP Net Loss

    Non-GAAP adjusted net loss, which excludes share-based compensation expenses, for the six months ended June 30, 2020 was RMB353.1 million (US$50.0 million), compared with RMB491.0 million for the six months ended June 30, 2019. Non-GAAP adjusted net loss per share attributable to ordinary shareholders for the six months ended June 30, 2020 was RMB2.90 (US$0.41), compared with RMB68.34 for the six months ended June 30, 2019.

    Conference Call and Webcast Information

    The Company will host a live conference call and webcast on August 31, 2020 at 8:00 a.m. ET. Participants must register in advance of the conference call. Details are as follows:

    Registration Link:

    http://apac.directeventreg.com/registration/event/8959387

    Conference ID:

    8959387

    Upon registering, each participant will receive a dial-in number, Direct Event passcode, and a unique access PIN, which can be used to join the conference call.

    A webcast replay will be archived on the Company's website for one year after the conclusion of the call at http://ir.i-mabbiopharma.com.

    A telephone replay will be available approximately two hours after the conclusion of the call. To access the replay, please call +1-855-452-5696 (U.S.), +61-2-8199-0299 (International), 400-632-2162 (Mainland China), or 800-963-117 (Hong Kong). The conference ID number for the replay is 8959387.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hong Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com

    Use of Non-GAAP Financial Measures

    To supplement its consolidated financial statements which are presented in accordance with U.S. GAAP, the Company uses adjusted net loss as a non-GAAP financial measure. Adjusted net loss represents net loss before share-based compensation. The Company's management believes that adjusted net loss facilitates better understanding of operating results and provide management with a better capability to plan and forecast future periods. For more information on the non-GAAP financial measures, please see the table captioned "Reconciliation of GAAP and Non-GAAP Results" set forth at the end of this press release.

    Non-GAAP information is not prepared in accordance with GAAP and may be different from non-GAAP methods of accounting and reporting used by other companies. The presentation of this additional information should not be considered a substitute for GAAP results. A limitation of using adjusted net loss is that adjusted net loss excludes share-based compensation expense that has been and may continue to be incurred in the future.

    Exchange Rate Information

    This announcement contains translations of certain RMB amounts into U.S. dollars at a specified rate solely for the convenience of the reader. Unless otherwise noted, all translations from Renminbi to U.S. dollars are made at a rate of RMB7.0651 to US$1.00, the rate in effect as of June 30, 2020 published by the Federal Reserve Board.

    Safe Harbor Statement

    This press release contains statements that may constitute "forward-looking" statements pursuant to the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "aims," "future," "intends," "plans," "believes," "estimates," "likely to" and similar statements. Statements that are not historical facts, including statements about I-Mab's beliefs, plans and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. Further information regarding these and other risks is included in I-Mab's filings with the SEC. All information provided in this press release is as of the date of this press release, and I-Mab does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, CFO

    E-mail:

    Office line: +86 21 6057 8000

    Gigi Feng, Vice President and Global Head of Corporate Communications

    E-mail: 

    Office line: +86 21 6057 8000

    Investor Inquiries:

    Burns McClellan, Inc. (Americas and Europe)

    Steve Klass

    E-mail:

    Office line: +1 212 213 0006

    The Piacente Group, Inc. (Asia)

    Emilie Wu

    E-mail:

    Office line: + 86 21 6039 8363

     

     

     

    I-MAB

    Consolidated Balance Sheets

    (All amounts in thousands, except for share and per share data, unless otherwise noted)











    As of December 31,



    As of June 30,









    2019



    2020









    RMB



    RMB



    US$ 



















    Assets

















    Current assets

















       Cash and cash equivalents







    1,137,473



    1,560,031



    220,808

    Restricted cash







    55,810



    -



    -

    Short-term investments







    32,000



    1,926



    273

    Prepayments and other receivables







    136,036



    131,130



    18,560

    Total current assets







    1,361,319



    1,693,087



    239,641

    Property, equipment and software







    30,069



    26,625



    3,769

    Operating lease right-of-use assets







    16,435



    17,592



    2,490

    Intangible assets







    148,844



    148,844



    21,068

    Goodwill







    162,574



    162,574



    23,011

    Other non-current assets







    18,331



    -



    -

    Total assets







    1,737,572



    2,048,722



    289,979



















    Liabilities, mezzanine equity and shareholders' equity (deficit)











    Current liabilities













    Short-term borrowings



    50,000



    -



    -

    Accruals and other payables



    273,553



    243,068



    34,404

    Operating lease liabilities, current



    6,807



    8,202



    1,161

    Ordinary shares to be issued to Everest



    258,119



    -



    -

    Total current liabilities







    588,479



    251,270



    35,565

       Convertible promissory notes







    68,199



    69,138



    9,787

    Operating lease liabilities, non-current







    7,492



    7,254



    1,027

    Deferred subsidy income







    3,920



    7,760



    1,098

    Other non-current liabilities







    -



    9,424



    1,334

    Total liabilities







    668,090



    344,846



    48,811



















    Mezzanine equity













    Series A convertible preferred shares (US$0.0001 par value,

       30,227,056 shares authorized, issued and outstanding as of

       December 31, 2019, and nil authorized, issued and

       outstanding as of June 30, 2020)

    687,482



    -



    -

    Series B convertible preferred shares (US$0.0001 par value,

       30,305,212 shares authorized, issued and outstanding as of

       December 31, 2019, and nil authorized, issued and

       outstanding as of June 30, 2020)

    921,243



    -



    -

    Series C convertible preferred shares (US$0.0001 par value,

       31,046,360 shares authorized, issued and outstanding as of

       December 31, 2019, and nil authorized, issued and

       outstanding as of June 30, 2020)

    1,306,633



    -



    -

    Series C-1 convertible preferred shares (US$0.0001 par value,

        3,857,143 shares authorized, issued and outstanding as of

        December 31, 2019, and nil authorized, issued and

        outstanding as of June 30, 2020)

    188,819



    -



    -

    Total mezzanine equity







    3,104,177



    -



    -

     

     

     

    I-MAB

    Consolidated Balance Sheets

    (All amounts in thousands, except for share and per share data, unless otherwise noted)













    As of December 31,



    As of June 30,



    2019



    2020



    RMB



    RMB



    US$ 

























    Shareholders' equity (deficit)











    Ordinary shares (US$0.0001 par value, 500,000,000 and

       800,000,000 shares authorized as of December 31, 2019 and June

       30, 2020, respectively; 8,363,719 and 133,006,644 shares issued

       and outstanding as of December 31, 2019 and June 30, 2020,

       respectively)

    6



    92



    13

    Additional paid-in capital

    389,379



    4,675,991



    661,844

    Accumulated other comprehensive income

    70,127



    104,853



    14,841

    Accumulated deficit

    (2,494,207)



    (3,077,060)



    (435,530)

    Total shareholders' equity (deficit)

    (2,034,695)



    1,703,876



    241,168

    Total liabilities, mezzanine equity and shareholders' equity 

      (deficit)

    1,737,572



    2,048,722



    289,979

     

     

     

    I-MAB

    Consolidated Statements of Comprehensive Loss

     (All amounts in thousands, except for share and per share data, unless otherwise noted)





    For the six months ended June 30,



    2019



    2020



    RMB



    RMB



    US$













    Revenues











    Licensing and collaboration revenue

    15,000



    -



    -













    Expenses











    Research and development expenses (Note 1)

    (265,084)



    (442,291)



    (62,602)

    Administrative expenses (Note 2)

    (574,584)



    (171,384)



    (24,258)

    Loss from operations

    (824,668)



    (613,675)



    (86,860)

    Interest income

    12,818



    18,955



    2,683

    Interest expense

    (1,936)



    (957)



    (135)

    Other gains, net

    303



    12,824



    1,815

    Fair value change of warrants

    (43,854)



    -



    -

    Loss before income tax expense

    (857,337)



    (582,853)



    (82,497)

    Income tax expense

    -



    -



    -

    Net loss attributable to I-MAB

    (857,337)



    (582,853)



    (82,497)

    Net loss attributable to ordinary shareholders

    (857,337)



    (582,853)



    (82,497)













    Net loss attributable to I-MAB

    (857,337)



    (582,853)



    (82,497)

    Foreign currency translation adjustments, net of nil tax

    (4,972)



    34,726



    4,915

    Total comprehensive loss attributable to I-MAB

    (862,309)



    (548,127)



    (77,582)













    Net loss attributable to ordinary shareholders

    (857,337)



    (582,853)



    (82,497)

    Weighted-average number of ordinary shares used in

       calculating net loss per share - basic and diluted

    7,184,086



    121,815,986



    121,815,986

    Net loss per share attributable to ordinary shareholders











    —Basic

    (119.34)



    (4.78)



    (0.68)

    —Diluted

    (119.34)



    (4.78)



    (0.68)













    Note:

    (1) Includes share-based compensation expense of RMB308 and RMB132,724 (US$18,786) for the six months ended June 30, 2019 and

    2020, respectively.

    (2) Includes share-based compensation expense of RMB366,048 and RMB97,071 (US$13,739) for the six months ended June 30, 2019 and

    2020, respectively.

     

     

     

    I-MAB

    Reconciliation of GAAP and Non-GAAP Results

    (All amounts in thousands, except for share and per share data, unless otherwise noted)





    For the six months ended June 30,





    2019



    2020





    RMB



    RMB



    US$















    GAAP net loss attributable to I-MAB



    (857,337)



    (582,853)



    (82,497)

    Add back:













    Share-based compensation expense



    366,356



    229,795



    32,525

    Non-GAAP adjusted net loss attributable to I-MAB



    (490,981)



    (353,058)



    (49,972)















    Non-GAAP adjusted net loss attributable to ordinary

        shareholders



    (490,981)



    (353,058)



    (49,972)

    Weighted-average number of ordinary shares used in

       calculating net loss per share - basic and diluted



    7,184,086



    121,815,986



    121,815,986

    Non-GAAP adjusted net loss per share attributable to

       ordinary shareholders













    —Basic



    (68.34)