GRCL Gracell Biotechnologies Inc.

20.91
-0.58  -3%
Previous Close 21.49
Open 21.49
52 Week Low 21.075
52 Week High 28.88
Market Cap $1,370,926,491
Shares 65,563,199
Float 65,563,199
Enterprise Value $1,402,396,830
Volume 143,757
Av. Daily Volume 188,070
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Drug Pipeline

Drug Stage Notes
GC027
B cell acute lymphoblastic leukemia
Phase 1
Phase 1
U.S. IND filing due 2022.
GC012F
Multiple myeloma
Phase 1
Phase 1
U.S. IND filing due 2H 2021.

Latest News

  1. SUZHOU and SHANGHAI, China, Jan. 19, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that the National Medical Products Administration (NMPA) in China has approved an investigational new drug (IND) application to study GC019F, a FasTCAR-enabled chimeric antigen receptor (CAR)-T therapy in patients with relapsed or refractory adult B-cell acute lymphoblastic leukemia (B-ALL).

    GC019F is an autologous CAR-T therapy currently in development for adult B-ALL patients who are relapsed from or refractory to prior therapies. With the therapy, a patient's own T cells are genetically modified to express CD19-specific CAR. GC019F is manufactured on Gracell's FasTCAR technology platform, which significantly reduces manufacturing time from an industry norm of two to six weeks down to 22 to 36 hours.

    "This marks the first IND approval for a product candidate manufactured on Gracell 's FasTCAR platform and sets an important milestone for furthering therapies manufactured on this platform. We are excited to bring this new therapy to adult B-ALL patients, who - once relapsed from or refractory to therapy - remain a high unmet medical need with limited treatment options in China," commented Dr. Martina Sersch, M.D., Ph.D., Chief Medical Officer of Gracell.

    About GC019F

    GC019F is an autologous investigational CD19-targeted CAR-T cell therapy, directed to eradicate CD19 positive leukemia cells.

    About FasTCAR

    FasTCAR-manufactured CAR-T cells appear younger, less exhausted and show enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities as demonstrated in preclinical studies. With next-day manufacturing (22 to 36 hours), FasTCAR is able to significantly improve cell production efficiency which may result in meaningful cost savings, increasing the accessibility of cell therapies for cancer patients. 

    About B-ALL

    B-ALL, a major form of acute lymphoblastic leukemia (ALL), is one of the most common forms of cancer in children between the ages of two and five and adults over the age of 50.[1] In 2015, ALL affected around 837,000 people globally and resulted in 110,000 deaths worldwide.[2] It is also the most common cause of cancer and death from cancer among children.

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors.

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the further advancement of, and anticipated clinical development and regulatory milestones of GC019F.The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all, and other factors discussed in the "Risk Factors" section of the preliminary prospectus filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

    Media contact

    Linc He



    +86 021 64031522

    Investor contact

    Gracie Tong

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/gracell-biotechnologies-receives-ind-approval-from-china-nmpa-for-gc019f-a-fastcar-enabled-car-t-therapy-for-the-treatment-of-relapsed-or-refractory-adult-b-all-301209901.html

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  2. SUZHOU, China, Jan. 15, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, has been granted the Medical Products Manufacturing Certificate (MPMC) from the Jiangsu Medical Products Administration (JSMPA, Jiangsu is a province/state in China) for its CAR-T cell therapy products. The certification was granted on January 4, 2021, and indicates that Gracell's site in Suzhou Industrial Park (SIP) has fully met the compliance requirements for Good Manufacturing Practice (GMP) in relation to the production of CAR-T cell therapy for cancer treatment.

    SUZHOU, China, Jan. 15, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, has been granted the Medical Products Manufacturing Certificate (MPMC) from the Jiangsu Medical Products Administration (JSMPA, Jiangsu is a province/state in China) for its CAR-T cell therapy products. The certification was granted on January 4, 2021, and indicates that Gracell's site in Suzhou Industrial Park (SIP) has fully met the compliance requirements for Good Manufacturing Practice (GMP) in relation to the production of CAR-T cell therapy for cancer treatment.

    Since the new Pharmaceutical Administration Law of the People's Republic of China took effect on December 1, 2019, GMP certification has been abolished in China and applications for GMP certification are no longer accepted by the National Medical Products Administration (NMPA). Instead, the "Measures for Supervision and Management of Medical Products Manufacturing", which came into effect on July 1, 2020, clearly outlines strict and detailed requirements regarding permissions and relevant supervisions for the manufacture of medical products. Only manufacturing sites that fully satisfy these stringent requirements can successfully pass an on-site inspection to obtain the "Medical Products Manufacturing Certificate".

    As of March 2020, Gracell has implemented a comprehensive Quality Management System that fully complies with the U.S. FDA cGMP, EU GMP, China GMP, and relevant global guidelines for cell therapy products.

    Gracell's Suzhou site underwent and successfully passed an on-site inspection conducted by JSMPA inspectors in November, 2020, and received its official "Medical Products Manufacturing Certificate" on January 4, making it one of five CAR-T cell therapy manufacturers nationwide to receive the license.

    "Our passion is to change the way conventional CAR-T therapies have been manufactured, and provide effective, low cost manufacturing of cellular gene therapeutics with fast turnaround time," said Dr. William (Wei) Cao, founder, Chairman, and CEO of Gracell. "We are thrilled to receive this certificate from JSMPA, which will enable us to further advance our current clinical programs including our FasTCAR-T programs and bring transformative CAR-T cell therapies to a broader group of patients."

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors.

    Cautionary Noted Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing date of the offering. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all, and other factors discussed in the "Risk Factors" section of the preliminary prospectus filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

    Media contact

    Linc He



    +86-21-6403-1375

    Investor contact

    Gracie Tong

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/gracell-biotechnologies-receives-medical-products-manufacturing-certificate-for-car-t-cell-therapy-products-301206090.html

    SOURCE Gracell Biotechnologies

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  3. SUZHOU and SHANGHAI, China, Jan. 13, 2021 /PRNewswire/ --  Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, has been granted approval for a pivotal seamless Phase 1/2 clinical trial for GC007g, an allogeneic donor-derived anti-CD19 chimeric antigen receptor (CAR)-T cell therapy, for the treatment of B-cell acute lymphoblastic leukemia (B-ALL), by China's National Medical Products Administration (NMPA) on December 24, 2020. The seamless Phase 1/2 pivotal clinical trial of GC007g will enable Gracell to potentially substantially accelerate the clinical development of GC007g in China. 

    SUZHOU and SHANGHAI, China, Jan. 13, 2021 /PRNewswire/ --  Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, has been granted approval for a pivotal seamless Phase 1/2 clinical trial for GC007g, an allogeneic donor-derived anti-CD19 chimeric antigen receptor (CAR)-T cell therapy, for the treatment of B-cell acute lymphoblastic leukemia (B-ALL), by China's National Medical Products Administration (NMPA) on December 24, 2020. The seamless Phase 1/2 pivotal clinical trial of GC007g will enable Gracell to potentially substantially accelerate the clinical development of GC007g in China. 

    GC007g is an allogeneic CAR-T therapy under development for the treatment of a subset of B-ALL patients who relapsed after receiving an allogeneic transplant. The allogeneic therapy is derived from human leukocyte antigen (HLA)-matched donor T cells. This allogeneic approach has the potential to resolve the T cell fitness issue associated with autologous CAR-T cell therapies. The donor-derived CAR-T cell therapy, GC007g, is designed for relaspsed/refractory B-ALL patients who may not be eligible for autologous CAR-T therapy due to poor cell fitness, infections, and other conditions.

    "The approval of the pivotal study for GC007g is an exciting milestone for the program, and more importanty, the approval of the new study design by the Chinese regulatory agency expedites the process of delivering a potential new treatment option to eligible patients in need," Dr. Martina Sersch, M.D., Chief Medical Officer of Gracell, commented. "As we continue to explore the potential  of GC007g, Gracell remains focused on developing innovative cell therapies for patients with high unmet medical needs."

    About GC007g

    GC007g is an investigational CD19-targeted CAR-T cell therapy, where HLA-matched donors' T cells were employed to be redirected to eradicate CD19 positive leukemia cells.

    About B-ALL

    B-ALL, a major form of acute lymphoblastic leukemia (ALL), is one of the most common forms of cancer in children between the ages of two and five and adults over the age of 50.[1] In 2015, ALL affected around 837,000 people globally and resulted in 110,000 deaths worldwide.[2] It is also the most common cause of cancer and death from cancer among children.

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors.

    Cautionary Noted Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing date of the offering. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all, and other factors discussed in the "Risk Factors" section of the preliminary prospectus filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

    Media contact

    Linc He



    +86-21-6403-1375

    Investor contact

    Gracie Tong

     

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  4. SUZHOU and SHANGHAI, China, Jan. 8, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies to address major industry challenges and fulfill unmet medical needs in the treatment of cancer, today announced the pricing of its initial public offering of 11,000,000 American Depositary Shares ("ADSs"), each representing five ordinary shares, at a public offering price of US$19.00 per ADS. The gross proceeds to Gracell from the offering are expected to be US$209.0 million, before deducting underwriting discounts and commissions and other offering expenses. In addition, Gracell has granted the underwriters a 30-day…

    SUZHOU and SHANGHAI, China, Jan. 8, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies to address major industry challenges and fulfill unmet medical needs in the treatment of cancer, today announced the pricing of its initial public offering of 11,000,000 American Depositary Shares ("ADSs"), each representing five ordinary shares, at a public offering price of US$19.00 per ADS. The gross proceeds to Gracell from the offering are expected to be US$209.0 million, before deducting underwriting discounts and commissions and other offering expenses. In addition, Gracell has granted the underwriters a 30-day option to purchase up to an additional 1,650,000 ADSs at the initial public offering price, less underwriting discounts and commissions. All of the ordinary shares represented by ADSs are being offered by Gracell.

    The ADSs have been approved for listing on The Nasdaq Global Market and are expected to begin trading on January 8, 2021 under the ticker symbol "GRCL". The offering is expected to close on January 12, 2021 subject to the satisfaction of customary closing conditions.

    Citigroup, Jefferies, Piper Sandler & Co. and Wells Fargo Securities are acting as joint book-running managers for the offering.

    The offering of the securities is made only by means of a prospectus forming a part of the effective registration statement. A copy of the prospectus relating to the offering may be obtained by contacting: Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (800) 831-9146 or by email at ; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at ; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at ; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, NY 10001, by telephone at (800) 326-5897 or by email at .

    Gracell's registration statement relating to the offering has been filed with, and declared effective by the U.S. Securities and Exchange Commission. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any 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 Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors.

    Cautionary Noted Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing date of the offering. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all, and other factors discussed in the "Risk Factors" section of the preliminary prospectus filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

    Media contact

    Linc He



    +86-21-6403-1375

    Investor contact

    Gracie Tong

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/gracell-biotechnologies-announces-pricing-of-initial-public-offering-301203264.html

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