ZLAB Zai Lab Limited

89.48
+2.61  (+3%)
Previous Close 86.87
Open 86.79
52 Week Low 29.43
52 Week High 89.48
Market Cap $6,681,964,724
Shares 74,675,511
Float 74,675,511
Enterprise Value $1,783,381,173
Volume 511,289
Av. Daily Volume 488,217
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Upcoming Catalysts

Drug Stage Catalyst Date
Margetuximab
Metastatic breast cancer
PDUFA
PDUFA
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FPA144 + chemo (FIGHT)
Gastric and gastro-esophageal junction cancer
Phase 2
Phase 2
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Tumor Treating Fields (TTFields) LUNAR
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Niraparib - PRIMA
Ovarian cancer
Approved
Approved
FDA Approval announced April 29, 2020.
Omadacycline
Complicated urinary tract infections (cUTI) / acute pyelonephritis
Phase 2
Phase 2
Phase 2 data released October 31, 2019. Comparable levels of clinical success but microbiological responses were generally lower than comparators.
Omadacycline
Urinary tract infections
Phase 2
Phase 2
Phase 2 data released October 31, 2019. Comparable levels of clinical success but microbiological responses were generally lower than comparators.
ZL-2306 (niraparib)
First-line maintenance therapy for platinum-responsive ovarian cancer
Phase 3
Phase 3
Phase 3 dosing initiated - noted June 29. 2018.
ZL-2306 (niraparib)
Recurrent platinum-sensitive ovarian cancer
NDA Filing
NDA Filing
China NDA filing announced December 12, 2018.

Latest News

  1. Zai Lab Granted Exclusive Rights to Develop and Commercialize Repotrectinib in Greater China

    Turning Point to Receive $25 Million Upfront, Potential for Future Milestones of up to $151 Million and Royalties

    TRIDENT-1 Phase 2 Registrational Study of Repotrectinib to Open Additional Sites in Greater China

    SAN DIEGO and SHANGHAI, July 07, 2020 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ:TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, and Zai Lab (NASDAQ:ZLAB), an innovative commercial-stage biopharmaceutical company, today announced an exclusive license agreement for the development and commercialization of Turning Point's lead drug candidate, repotrectinib, in…

    Zai Lab Granted Exclusive Rights to Develop and Commercialize Repotrectinib in Greater China

    Turning Point to Receive $25 Million Upfront, Potential for Future Milestones of up to $151 Million and Royalties

    TRIDENT-1 Phase 2 Registrational Study of Repotrectinib to Open Additional Sites in Greater China

    SAN DIEGO and SHANGHAI, July 07, 2020 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ:TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, and Zai Lab (NASDAQ:ZLAB), an innovative commercial-stage biopharmaceutical company, today announced an exclusive license agreement for the development and commercialization of Turning Point's lead drug candidate, repotrectinib, in Greater China, which includes mainland China, Hong Kong, Macau and Taiwan.

    Under the terms of the agreement, Zai Lab will obtain exclusive rights to develop and commercialize repotrectinib in Greater China and Turning Point Therapeutics will receive a $25 million upfront payment, with potential to receive up to an additional $151 million in development, regulatory and sales-based milestone payments. Turning Point will also be eligible to receive mid-to-high teen royalties based on annual net sales of repotrectinib in Greater China.

    "With more than 700,000 newly diagnosed lung cancer patients every year in Greater China, and the development and commercialization capabilities Zai Lab have shown over time in the region, we view Zai Lab as the ideal partner to help expand the potential reach of repotrectinib," said Athena Countouriotis, M.D., President and Chief Executive Officer of Turning Point Therapeutics. "Our collaboration with Zai Lab is a strategic step to potentially accelerate the development of repotrectinib in Greater China."

    Zai Lab anticipates opening additional sites for the TRIDENT-1 Phase 2 registrational clinical study of repotrectinib. The ongoing study is currently active in 11 countries globally and enrolling patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) and NTRK-positive solid tumors.

    "We are very pleased to enter into this agreement with Turning Point Therapeutics. Repotrectinib is highly synergistic with Zai's existing pipeline and further strengthens our disease area strongholds across most common tumor types in China, particularly in lung cancer. We are looking forward to bringing this potential best-in-class agent in the front-line setting and for patients previously treated with an approved tyrosine kinase inhibitor (TKI) where there are no approved targeted therapies," said Samantha Du, Ph.D., Founder, Chairwoman and Chief Executive Officer of Zai Lab.

    "In China, there is only one approved targeted therapy for patients with advanced ROS1-positive lung cancer and despite its efficacy, most patients eventually acquire resistance," said Dr. Lu Shun, Director of Chinese Lung Cancer Association. "The unmet need in the ROS1-positive lung cancer patient population is significant. The preliminary clinical activity and safety data generated to date for repotrectinib represent a promising clinical profile. If approved, repotrectinib has the potential to be the standard of care for ROS1-positive patients with advanced non-small cell lung cancer in China."

    About Repotrectinib

    Repotrectinib is an investigational next-generation TKI designed to effectively target ROS1 and TRK A/B/C with potential to treat TKI-naïve or -pretreated patients. ROS1 rearrangement is estimated to be an oncogenic driver in approximately 2 to 3 percent of patients with advanced NSCLC in China, and NTRK is estimated to be an oncogenic driver in approximately 0.5 percent of patients with other advanced solid tumors in China.

    Utilizing a 22 July 2019 data cut-off, data from the Phase 1 portion of TRIDENT-1 demonstrated the potential for repotrectinib to be best-in-class for the treatment of ROS1-positive advanced NSCLC in patients who were not previously treated with a TKI, with a 91 percent overall response rate by blinded independent central review, a median duration of response of 23.1 months, a median progression-free survival of 24.6 months, and a generally well-tolerated adverse-event profile.

    More information about the ongoing TRIDENT-1 study of repotrectinib may be found by searching clinical trial identifier NCT03093116 at https://clinicaltrials.gov.

    About Zai Lab

    Zai Lab (NASDAQ:ZLAB) is an innovative commercial stage biopharmaceutical company focused on bringing transformative medicines for cancer, infectious and autoimmune diseases to patients in China and around the world. To quickly target the large, fast-growing segments of China's pharmaceutical market and address unmet medical needs, Zai Lab's experienced team has secured partnerships with leading global biopharma companies, generating a broad pipeline of innovative drug candidates. Zai Lab has also built an in-house team with strong drug discovery and translational research capabilities, aiming to establish a global pipeline of proprietary drug candidates against targets in our focus areas. Zai Lab's vision is to become a fully integrated biopharmaceutical company, discovering, developing, manufacturing and commercializing its portfolio in order to impact human health worldwide.

    For additional information about the company, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.

    About Turning Point Therapeutics Inc.

    Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company's lead drug candidate, repotrectinib, is a next-generation kinase inhibitor targeting the ROS1 and TRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors. Repotrectinib, which is being studied in a registrational Phase 2 study in adults and a Phase 1/2 study in pediatric patients, has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients. The company's pipeline of drug candidates also includes TPX-0022, targeting MET, CSF1R and SRC, which is being studied in a Phase 1 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in MET; TPX-0046, targeting RET and SRC, which is being studied in a Phase 1/2 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in RET; and TPX-0131, a next-generation ALK inhibitor in IND-enabling studies. Turning Point's next-generation kinase inhibitors are designed to bind to their targets with greater precision and affinity than existing therapies, with a novel, compact structure that has demonstrated an ability to potentially overcome treatment resistance common with other kinase inhibitors. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment. For more information, visit www.tptherapeutics.com.

    Zai Lab Forward Looking Statements

    This press release contains statements about future expectations, plans and prospects for Zai Lab, including, without limitation, statements regarding the prospects of and plans for commercializing repotrectinib in mainland China, Hong Kong, Macau and Taiwan. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact nor are they guarantees or assurances of future performance. Forward-looking statements are based on Zai Lab's expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) Zai Lab's ability to obtain additional future funding, (2) Zai Lab's results of clinical and pre-clinical development of its drug candidates, (3) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of Zai Lab's drug candidates, (4) Zai Lab's ability to generate revenue from its drug candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on general economic, regulatory and political conditions and (6) other factors discussed in Zai Lab's Annual Report on Form 20-F for the fiscal year ended December 31, 2019, filed on April 29, 2020, and its other filings with the Securities and Exchange Commission. Zai Lab anticipates that subsequent events and developments will cause Zai Lab's expectations and assumptions to change and 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. These forward-looking statements should not be relied upon as representing Zai Lab's views as of any date subsequent to the date of this press release.

    Turning Point Therapeutics Forward Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of Turning Point Therapeutics' drug candidate repotrectinib, the results, conduct, and progress of Turning Point Therapeutics' TRIDENT-1 clinical study of repotrectinib, including the ability of Zai Lab to open additional sites and the potential to accelerate the development of repotrectinib in Greater China, the ability to expand the potential reach of repotrectinib to patients in Greater China, and the potential to receive milestone and royalty payments from Zai Lab. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "plans", "will", "believes," "anticipates," "expects," "intends," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Turning Point Therapeutics' current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Turning Point Therapeutics' business in general, risks and uncertainties related to the impact of the COVID-19 pandemic to Turning Point's business, and the other risks described in Turning Point Therapeutics' filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Turning Point Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    CONTACTS:

    Zai Lab

    Billy Cho, CFO

    +86 137 6151 2501

    Turning Point Therapeutics

    Jim Mazzola



    858-342-8272
      
    Media: Ryo Imai / Robert Flamm, Ph.D.

    Burns McClellan, on behalf of Zai Lab

    212-213-0006 ext. 315 / 364

    /
     
      
    Investors: Pete Rahmer / Mike Zanoni

    Endurance Advisors, on behalf of Zai Lab

    415-515-9763 / 610-442-8570

    /
     
      

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  2. SHANGHAI, June 28, 2020 /PRNewswire/ -- Chinese insulin manufacturer Gan & Lee Pharmaceuticals (SHSE: 603087), Qiming's portfolio company today lands on the A-shares main board market. The issue price of Gan & Lee is RMB 63.32 per share. The stock opens at RMB 91.18 per share, up 44%, with a market cap of RMB 36.57 billion.

    The listing of Gan & Lee marks Qiming's fifth IPO exit in 2020, following RoboRock (SHSE:688169), Schrödinger (NASDAQ:SDGR), Sanyou Medical (SHSE:688085) and SinocellTech (SHSE: 688520).

    In 2010, Qiming was the sole investor in Gan & Lee's Series A round; in 2011, Qiming led the company's Series B round. Qiming is the largest institutional investor of Gan & Lee.

    The core business of Gan & Lee is development, manufacturing…

    SHANGHAI, June 28, 2020 /PRNewswire/ -- Chinese insulin manufacturer Gan & Lee Pharmaceuticals (SHSE: 603087), Qiming's portfolio company today lands on the A-shares main board market. The issue price of Gan & Lee is RMB 63.32 per share. The stock opens at RMB 91.18 per share, up 44%, with a market cap of RMB 36.57 billion.

    The listing of Gan & Lee marks Qiming's fifth IPO exit in 2020, following RoboRock (SHSE:688169), Schrödinger (NASDAQ:SDGR), Sanyou Medical (SHSE:688085) and SinocellTech (SHSE: 688520).

    In 2010, Qiming was the sole investor in Gan & Lee's Series A round; in 2011, Qiming led the company's Series B round. Qiming is the largest institutional investor of Gan & Lee.

    The core business of Gan & Lee is development, manufacturing and commercialization of recombinant insulin analogues (third-generation insulin) and active pharmaceutical ingredients. Founded by Dr. Gan Zhongru, a pioneer in China's insulin industry, Gan & Lee has achieved multiple breakthroughs in the Chinese biopharmaceutical industry.

    In 2001, Gan & Lee successfully developed third-generation insulin technology and was the first Chinese company to achieve large scale manufacturing and commercialize recombinant insulin analogue. It launched the first fast-acting human insulin analogue "Prandilin®" (insulin lispro) in China. In 2002, it launched the first long-acting human insulin analogue "Basalin®" (insulin glargine) and the first premixed insulin analogue "Parandilin®25" in China. The three recombinant insulin analogue products cover the three insulin function segments of long-acting, fast-acting and medium-acting. In 2020, Gan & Lee's insulin aspart injection was approved for marketing by China's National Medical Products Administration (NMPA). 

    IMS data shows that the market share of the third-generation insulin accounts for 80% in the US and European countries. After the third-generation insulin entered China, its market share rose to 50% (2016) from 40% (2011). Gan & Lee's products have a distinct price advantage, which can significantly lessen the burden of diabetes patients.

    By end of 2019, Gan & Lee's products have been sold to nearly 7,700 hospitals in China, including over 2,400 Grade 3-level hospitals. It expanded its sales network to more than 20 countries. In 2018, Gan & Lee and Sandoz announced a US and European commercialization partnership for three of its insulin analogs. It has announced construction of a second manufacturing facility in Linyi, Shandong Province, which will produce company's pipeline drugs for global consumption.

    Dr. Gan Zhongru stated his vision: "The company will actively participate in the R&D of oncology drugs, eukaryotic and prokaryotic protein engineering, cardiovascular and metabolic diseases. We aim to become a world-class pharmaceutical company and will never stop exploring for more."

    "Gan & Lee is the first Qiming investment in biopharmaceutical sector and it is an honor to work alongside Dr. Gan for the last 10 years and to witness how it grew from a startup to becoming one of the global leaders in the diabetes sector and beyond. Under the leadership of Dr. Gan, the company has always thrived for cutting-edge technology and to be a research centric pharmaceutical company," said Nisa Leung, Managing Partner of Qiming Venture Partners. "We look forward to seeing Gan & Lee continue to building a strong metabolic portfolio as well as other innovative drugs for China and globally."

    About Qiming Venture Partners

    Founded in 2006, Qiming Venture Partners is a leading China venture capital firm with offices in Shanghai, Beijing, Suzhou, Shenzhen, Hong Kong, Seattle, Boston and San Francisco Bay Area. 

    Currently Qiming Venture Partners manages nine US Dollar funds and five RMB funds with $5.3 billion assets under management. Since our establishment, we have invested in outstanding companies in the TMT and healthcare industries at the early and growing stages.

    Since our debut, we have backed over 350 fast-growing and innovative companies. Over 110 companies are already listed on NYSE, NASDAQ, HKEx, Gretai Securities Market, Shanghai Stock Exchange and Shenzhen Stock Exchange, or achieved exit through M&A and other means. There are also over 30 portfolio companies that have achieved unicorn status. 

    Many of our portfolio companies are today's most influential firms in their respective sectors, including Xiaomi (SEHK:1810), Meituan Dianping (SEHK:3690), Bilibili (NASDAQ:BILI), Roborock (SHSE:688169), Gan & Lee (SHSE: 603087), Tigermed (SZSE:300347), Zai Lab (NASDAQ:ZLAB), Venus MedTech (SEHK:2500), CanSino (SEHK:6185), Schrödinger (NASDAQ:SDGR), Sanyou Medical (SHSE:688085), AmoyDx (SZSE:300685), Berry Genomics (SZSE:000710), SinocellTech (SHSE: 688520), WeDoctor Group, UBTech among many others.

     

    Cision View original content:http://www.prnewswire.com/news-releases/qimings-portfolio-company-gan--lee-pharmaceuticals-lands-a-shares-main-board-301084811.html

    SOURCE Qiming Venture Partners

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  3. SHANGHAI, June 21, 2020 /PRNewswire/ -- Chinese biologic drug developer SinocellTech, Qiming's portfolio company, today lands on the Science and Technology Innovation Board (the STAR Market). The issue price of SinocellTech (SHSE: 688520) is CNY 25.64 per share. The stock opens at CNY 85 per share with a market cap of CNY 37 billion.

    The listing of SinocellTech marks Qiming's third exit on the STAR Market in 2020, following the listing of RoboRock (SHSE:688169) in Feburary and Sanyou Medical (SHSE:688085) in April. Qiming Venture Partners led the Series A round of SinocellTech in 2017.

    "We are pleased to see another of our portfolio companies going public on the STAR Market. We are fortunate to have the opportunity to have invested in good companies…

    SHANGHAI, June 21, 2020 /PRNewswire/ -- Chinese biologic drug developer SinocellTech, Qiming's portfolio company, today lands on the Science and Technology Innovation Board (the STAR Market). The issue price of SinocellTech (SHSE: 688520) is CNY 25.64 per share. The stock opens at CNY 85 per share with a market cap of CNY 37 billion.

    The listing of SinocellTech marks Qiming's third exit on the STAR Market in 2020, following the listing of RoboRock (SHSE:688169) in Feburary and Sanyou Medical (SHSE:688085) in April. Qiming Venture Partners led the Series A round of SinocellTech in 2017.

    "We are pleased to see another of our portfolio companies going public on the STAR Market. We are fortunate to have the opportunity to have invested in good companies in the healthcare and TMT sectors at an early stage," said Nisa Leung, Managing Partner of Qiming Venture Partners. "SinocellTech has multiple products in the pipeline that have entered Phase III clinical trial. It will not be long before Me-Better or Best-in-Class innovative biopharmaceutical drugs be available in the market to cater for unmet medical needs."

    Founded in 2007, SinocellTech focuses on the development and manufacturing of biopharmaceutical drugs, including monoclonal antibodies, recombinant proteins and vaccines. The firm is an innovative biotech dedicated to the development of biologics with distinct advantages.

    After more than a decade of effort, SinocellTech has established a high-efficiency, high-throughput technology platform covering the entire chain of biologic R&D and production, and has developed diversified and distinguished monoclonal antibodies, recombinant proteins and vaccines among other biologic pipelines.

    As of May 15, 2020, SinocellTech has 23 products in the pipeline, among which 21 are innovative drugs, and two are biosimilar drugs. The market approval applications of two products have been accepted; six products have been approved for clinical research; six products have entered the pre-clinical research stage, and nine products have entered the phase of drugability evaluation.

    SinocellTech has multiple targeted drugs at the stage of discovery. All products are independently developed by the company and have commercial rights worldwide. SinocellTech has reserved a rich pipeline of early-stage drug candidates covering multiple categories, including recombinant proteins, monoclonal antibodies, and cell therapy, which will enable the continuous launch of products for pre-clinical and clinical research.

    "China's innovative drug industry will likely boom as the country has introduced multiple new drug review policies. The structural adjustment of drug use and the support from the capital market also accelerated the trend," said Amy Tang, Venture Partner of Qiming Venture Partners. "Under the leadership of founder Dr. Xie Liangzhi and the management team, SinocellTech has made tremendous efforts in strengthening the technology platform and expanding pipeline since its founding. We believe that with its technical advantages and hard work, SinocellTech will become an innovative pharmaceutical company of high potential."

    According to the forecast of Frost & Sullivan, a consulting firm, the biopharmaceuticals market where SinocellTech is at is proliferating. The global biopharmaceutical market is expected to increase from US$261.8 billion in 2018 to US$402.1 billion in 2023, with a compound annual growth rate close to 9.0%. With the economic growth and the rising prevalence of chronic diseases in China, the Chinese biopharmaceutical market will increase from 262.2 billion yuan in 2018 to 641.2 billion yuan in 2023, with a compound annual growth rate close to 19.6%.

    About Qiming Venture Partners

    Founded in 2006, Qiming Venture Partners is a leading China venture capital firm with offices in Shanghai, Beijing, Suzhou, Shenzhen, Hong Kong, Seattle, Boston and San Francisco Bay Area. 

    Currently Qiming Venture Partners manages nine US Dollar funds and five RMB funds with $5.3 billion assets under management. Since our establishment, we have invested in outstanding companies in the TMT and healthcare industries at the early and growing stages.

    Since our debut, we have backed over 350 fast-growing and innovative companies. Over 110 companies are already listed on NYSE, NASDAQ, HKEx, Gretai Securities Market, Shanghai Stock Exchange and Shenzhen Stock Exchange, or achieved exit through M&A and other means. There are also over 30 portfolio companies that have achieved unicorn status. 

    Many of our portfolio companies are today's most influential firms in their respective sectors, including Xiaomi (SEHK:1810), Meituan Dianping (SEHK:3690), Bilibili (NASDAQ:BILI), Roborock (SHSE:688169), Tigermed (SZSE:300347), Zai Lab (NASDAQ:ZLAB), Venus MedTech (SEHK:2500), CanSino (SEHK:6185), Schrödinger (NASDAQ:SDGR), Sanyou Medical (SHSE:688085), AmoyDx (SZSE:300685), Berry Genomics (SZSE:000710), WeDoctor Group, UBTech among many others.

    Cision View original content:http://www.prnewswire.com/news-releases/qimings-portfolio-company-sinocelltech-lands-on-star-market-301080816.html

    SOURCE Qiming Venture Partners

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  4. - The NORA study meets all primary and secondary endpoints

    - Largest randomized clinical trial (RCT) in ovarian cancer ever conducted in China 

     - Individualized starting dose regimen shown to be effective with improved safety profile in Chinese patients

    SHANGHAI and SAN FRANCISCO, May 28, 2020 (GLOBE NEWSWIRE) -- Zai Lab Limited ("Zai Lab") (NASDAQ:ZLAB), an innovative commercial-stage biopharmaceutical company, today announced positive topline results from the NORA study, the Phase 3 randomized, double-blind, placebo-controlled, study of ZEJULA (niraparib) as a maintenance therapy in Chinese patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (collectively termed as ovarian cancer) who are in a complete…

    - The NORA study meets all primary and secondary endpoints

    - Largest randomized clinical trial (RCT) in ovarian cancer ever conducted in China 

     - Individualized starting dose regimen shown to be effective with improved safety profile in Chinese patients

    SHANGHAI and SAN FRANCISCO, May 28, 2020 (GLOBE NEWSWIRE) -- Zai Lab Limited ("Zai Lab") (NASDAQ:ZLAB), an innovative commercial-stage biopharmaceutical company, today announced positive topline results from the NORA study, the Phase 3 randomized, double-blind, placebo-controlled, study of ZEJULA (niraparib) as a maintenance therapy in Chinese patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (collectively termed as ovarian cancer) who are in a complete or partial response to platinum-based chemotherapy.

    The NORA study randomized 265 patients at 2:1 to receive ZEJULA or placebo until disease progression. The study evaluated the efficacy of ZEJULA as a maintenance treatment, with the primary endpoint of progression-free survival (PFS) as assessed by blinded independent central review. The starting dose was individualized at 200 mg except for those with a baseline body weight >77kg and a platelet count >150K/μL in which case the starting dose is 300 mg. The study met its primary endpoint of a statistically significant improvement in progression free survival for patients with ovarian cancer regardless of their biomarker status. The safety profile was consistent with what was observed from the global NOVA study with lower rates of anemia and thrombocytopenia.

    "The NORA clinical data in Chinese patients confirmed the compelling clinical profile of ZEJULA and were consistent with the results seen in the global NOVA study," said Dr. Samantha Du, Founder, Chairwoman and Chief Executive Officer. "Importantly, the NORA study demonstrated an individualized starting dose regimen at 200 mg preserved the efficacy while improving safety profile in Chinese patients, particularly with regard to the hematological toxicities. Building on both the promising results of NOVA and Zai Lab's PK study that demonstrated no ethnicity difference between Chinese and global subjects, the NORA study further underscores the promise of ZEJULA as a maintenance therapy for Chinese patients with platinum-sensitive recurrent ovarian cancer."

    "The data of the NORA study will have a significant impact on the clinical practice in the treatment of ovarian cancer in China and beyond, as the individualized starting dose regimen has demonstrated clear clinical benefit with improved safety profile," said Dr. Xiaohua Wu, Professor and Chair of Gynecologic Oncology Department of Fudan University Shanghai Cancer Centre. "In addition, the NORA study is the first fully powered, randomized, controlled (RCT) Phase 3 trial ever done in ovarian cancer in China."

    The full results from the NORA study will be presented at an upcoming scientific meeting.

    About Ovarian Cancer

    Ovarian cancer is one of the most common gynecologic cancers in China with more than 52,000 newly diagnosed cases and 23,000 deaths each year. While platinum-based chemotherapy is effective at inducing an initial response in ovarian cancer, the disease will recur in the majority of women. New agents that prolong the duration of response following platinum-based treatment and delay the inevitable relapse of ovarian cancer will benefit patients with ovarian cancer in China.

    About ZEJULA (niraparib)

    ZEJULA (niraparib) is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. The NMPA is currently reviewing Zai Lab's sNDA under priority review for niraparib as maintenance treatment in patients with first-line ovarian cancer following platinum-based chemotherapy.

    Additional development program for niraparib in ovarian cancer by Zai Lab includes an ongoing pivotal study of niraparib as first-line maintenance therapy for Chinese patients with ovarian cancer following platinum-based chemotherapy. Previously, Zai Lab conducted a Phase 1 pharmacokinetic (PK) study of niraparib in Chinese patients with ovarian cancer. This study was published in August 2019 in The Oncologist and demonstrated that the PK profile of niraparib in Chinese patients were comparable to that of patients evaluated in ZEJULA's global PK study.

    Zai Lab in-licensed rights to ZEJULA from GSK for Mainland China, Hong Kong and Macau. The NDA for recurrent ovarian cancer was accepted by the NMPA in December 2018, granted priority review status in January 2019 and approved in December 2019. Zai Lab has obtained approval to market ZEJULA in Mainland China, Hong Kong and Macau for maintenance therapy in patients with platinum-sensitive, recurrent ovarian cancer. In March 2020, China NMPA accepted our sNDA for ZEJULA for first-line maintenance treatment of patients with ovarian cancer.

    About Zai Lab

    Zai Lab (NASDAQ:ZLAB) is an innovative commercial stage biopharmaceutical company focused on bringing transformative medicines for cancer, infectious and autoimmune diseases to patients in China and around the world. To quickly target the large, fast-growing segments of China's pharmaceutical market and address unmet medical needs, Zai Lab's experienced team has secured partnerships with leading global biopharma companies, generating a broad pipeline of innovative drug candidates. Zai Lab has also built an in-house team with strong drug discovery and translational research capabilities, aiming to establish a global pipeline of proprietary drug candidates against targets in our focus areas. Zai Lab's vision is to become a fully integrated biopharmaceutical company, discovering, developing, manufacturing and commercializing its portfolio in order to impact human health worldwide.

    For additional information about the company, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.

    Zai Lab Forward-Looking Statements

    This press release contains statements about future expectations, plans and prospects for Zai Lab, including, without limitation, statements regarding the prospects of and plans for commercializing ZEJULA in China. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact nor are they guarantees or assurances of future performance. Forward-looking statements are based on Zai Lab's expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) Zai Lab's ability to obtain additional future funding, (2) Zai Lab's results of clinical and pre-clinical development of its drug candidates, (3) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of Zai Lab's drug candidates, (4) Zai Lab's ability to generate revenue from its drug candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on general economic, regulatory and political conditions and (6) other factors discussed in Zai Lab's Annual Report on Form 20-F for the fiscal year ended December 31, 2019, filed on April 29, 2020, and its other filings with the Securities and Exchange Commission. Zai Lab anticipates that subsequent events and developments will cause Zai Lab's expectations and assumptions to change and 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. These forward-looking statements should not be relied upon as representing Zai Lab's views as of any date subsequent to the date of this press release.

    For more information, please contact:

    ZAI LAB CONTACTS:

    Zai Lab
    Billy Cho, CFO
    +86 137 6151 2501

    Media: Ryo Imai / Robert Flamm, Ph.D.
    Burns McClellan, on behalf of Zai Lab
    212-213-0006 ext. 315 / 364
    /  

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  5. SHANGHAI and SAN FRANCISCO, May 18, 2020 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ:ZLAB), an innovative commercial stage biopharmaceutical company, today announced dosing of the first Chinese patient in the global ATTACK (Acinetobacter Treatment Trial Against Colistin) Phase 3 registrational trial evaluating the combination of sulbactam and durlobactam (SUL-DUR) for the treatment of carbapenem-resistant Acinetobacter baumannii infections.

    "With over 200,000 occurrences estimated each year, China ranks among the countries with the highest incidence of A. baumannii infections in the world. Most cases are caused by strains resistant to carbapenem antibiotics which are very difficult organisms to treat. For these patients where mortality rates…

    SHANGHAI and SAN FRANCISCO, May 18, 2020 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ:ZLAB), an innovative commercial stage biopharmaceutical company, today announced dosing of the first Chinese patient in the global ATTACK (Acinetobacter Treatment Trial Against Colistin) Phase 3 registrational trial evaluating the combination of sulbactam and durlobactam (SUL-DUR) for the treatment of carbapenem-resistant Acinetobacter baumannii infections.

    "With over 200,000 occurrences estimated each year, China ranks among the countries with the highest incidence of A. baumannii infections in the world. Most cases are caused by strains resistant to carbapenem antibiotics which are very difficult organisms to treat. For these patients where mortality rates are approaching 50%, new antibiotics replacing colistin are clearly needed," said Harald Reinhart, M.D., Chief Medical Officer, Autoimmune and Infectious Diseases. "Given the excellent in-vitro activity of sulbactam/durlobactam against MDR Acinetobacter and the demonstrated safety of the combination in clinical trials, we look forward to collaborating with our partner, Entasis Therapeutics, in the ATTACK trial."

    ATTACK is a global, two-part Phase 3 registrational trial enrolling approximately 300 patients with pneumonia and bloodstream infections caused by carbapenem-resistant Acinetobacter baumannii. The data readout is expected in early 2021. Zai Lab and its partner, Entasis Therapeutics, will cooperate in conducting the trial in China with Zai Lab taking the operational lead by conducting the screening, enrollment and treatment of patients and coordinating development, registration and commercialization of SUL-DUR in specified countries in the Asia-Pacific region including Japan.

    About Acinetobacter baumannii Infections

    A. baumannii is a Gram-negative bacterium causing severe infections associated with high mortality and has emerged as a cause of numerous global outbreaks, displaying ever-increasing rates of antibiotic resistance, which greatly limits treatment options. Consequently, the World Health Organization (WHO) has placed carbapenem-resistant A. baumannii at the top of its list of "Critical" priority pathogens for new antibiotics. The U.S. Centers for Disease Control (CDC) also recognizes A. baumannii as a serious public health threat and estimates that 63% of A. baumannii are multidrug-resistant.

    In China, A. baumannii accounts for approximately 11% of total Gram-negative infections. Based on a national surveillance of over 1,300 hospitals in China, there are over 200,000 A. baumannii infections per year, although the actual incidence is estimated to be much larger. The resistance of A. baumannii to the carbapenem class of antibiotics has increased significantly, estimated at 60% in 2016, with some provinces as high as 70-80%. In other Asia-Pacific countries, such as Japan and Korea, this pathogen has also become an increasingly significant challenge for physicians. Due to the high rates of multidrug-resistant infections, the Chinese government has announced the goal of developing one to two innovative anti-infective drugs by 2020.

    About Sulbactam-Durlobactam (SUL-DUR)

    Durlobactam (DUR; previously designated ETX2514) is a novel broad-spectrum intravenous inhibitor of class A, C and D beta-lactamases. Sulbactam (SUL) is a generic β-lactam antimicrobial with activity against Acinetobacter baumannii; however, β-lactamase-mediated resistance to sulbactam is now widespread rendering it generally ineffective. In preclinical studies, durlobactam inhibits the β-lactamases commonly found in A. baumannii thus restoring sulbactam's antimicrobial activity. Entasis Therapeutics is developing SUL-DUR (previously designated ETX2514SUL), a fixed-dose combination of durlobactam and sulbactam, as a novel intravenous antibiotic for the treatment of a variety of serious multidrug-resistant infections caused by A. baumannii. A Phase 2 trial and several Phase 1 trials of SUL-DUR have recently been completed with positive results for pharmacokinetics and safety/tolerability. SUL-DUR has been designated a Qualified Infectious Disease Product (QIDP) by the U.S. Food and Drug Administration and awarded Fast Track status.

    About Zai Lab

    Zai Lab (NASDAQ:ZLAB) is an innovative commercial stage biopharmaceutical company focused on bringing transformative medicines for cancer, infectious and autoimmune diseases to patients in China and around the world. To quickly target the large, fast-growing segments of China's pharmaceutical market and address unmet medical needs, Zai Lab's experienced team has secured partnerships with leading global biopharma companies, generating a broad pipeline of innovative drug candidates. Zai Lab has also built an in-house team with strong drug discovery and translational research capabilities, aiming to establish a global pipeline of proprietary drug candidates against targets in our focus areas. Zai Lab's vision is to become a fully integrated biopharmaceutical company, discovering, developing, manufacturing and commercializing its portfolio in order to impact human health worldwide.

    For additional information about the company, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.

    Zai Lab Forward-Looking Statements

    This press release contains statements about future expectations, plans and prospects for Zai Lab, including, without limitation, statements regarding the prospects of and plans for commercializing SUL-DUR in China. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact nor are they guarantees or assurances of future performance. Forward-looking statements are based on Zai Lab's expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) Zai Lab's ability to obtain additional future funding, (2) Zai Lab's results of clinical and pre-clinical development of its drug candidates, (3) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of Zai Lab's drug candidates, (4) Zai Lab's ability to generate revenue from its drug candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on general economic, regulatory and political conditions and (6) other factors discussed in Zai Lab's Annual Report on Form 20-F for the fiscal year ended December 31, 2019, filed on April 29, 2020, and its other filings with the Securities and Exchange Commission. Zai Lab anticipates that subsequent events and developments will cause Zai Lab's expectations and assumptions to change and 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. These forward-looking statements should not be relied upon as representing Zai Lab's views as of any date subsequent to the date of this press release.

    For more information, please contact:

    ZAI LAB CONTACTS:

    Zai Lab
    Billy Cho, CFO
    +86 137 6151 2501

    Media: Ryo Imai / Robert Flamm, Ph.D.
    Burns McClellan, on behalf of Zai Lab
    212-213-0006 ext. 315 / 364
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    Investors: Pete Rahmer / Mike Zanoni
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    415-515-9763 / 610-442-8570
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