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  • Nature Medicine Publishes Results from an Investigator-Initiated Trial of CARsgen’s CT041 Claudin18.2 CAR T Cells in Gastrointestinal Cancers

    SHANGHAI, May 10, 2022 — CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that the phase I trial interim results of an investigator-initiated trial of CT041 have been published in Nature Medicine (https://www.nature.com/articles/s41591-022-01800-8), which is one of the top international medical journals in the Nature Portfolio (2-year Impact Factor of 53.44).

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  • CARsgen to Present Two Clinical Trials of CT041 at ASCO Annual Meeting

    SHANGHAI, April 28, 2022 -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T cell therapies for the treatment of hematologic malignancies and solid tumors, announces that the abstracts of CT041 have been accepted for presentations of the research updates at the 2022 annual meeting of American Society of Clinical Oncology (“2022 ASCO Annual Meeting”). The abstracts will be published soon. CT041 is an autologous CAR T-cell product candidate against Claudin18.2 (“CLDN18.2”) developed by CARsgen. The studies are named “Multicenter Phase 1b Trial in U.S. of Salvage CT041 CLDN18.2-specific Chimeric Antigen Receptor T Cell Therapy for Patients with Advanced Gastric and Pancreatic Adenocarcinoma” and “Safety, Tolerability and Preliminary Efficacy Results in Patients with Advanced Gastric/Gastroesophageal Junction Adenocarcinoma from a Phase Ⅰb/Ⅱ Study of CLDN18.2 CAR T-cell Therapy (CT041)” respectively. The ASCO Annual Meeting is one of the most authoritative academic events in global oncology field.

     

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  • CARsgen Appoints Dr. Raffaele Baffa as Chief Medical Officer

    SHANGHAI and BOSTON, April 8, 2022 -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T cell therapies for the treatment of hematologic malignancies and solid tumors, announces that Dr. Raffaele Baffa (“Dr. Baffa”) has been appointed as the Chief Medical Officer (“CMO”) of the Company, responsible for overseeing the global clinical development strategies and operations for the Company’s innovative pipeline product candidates. Dr. Baffa will report to Dr. Zonghai Li, Founder, Chairman of the Board, CEO, CSO of CARsgen Therapeutics Holdings Limited.

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  • CARsgen Announces First Patient Enrollment in the Confirmatory Phase II Clinical Trial of CT041 in China

    SHANGHAI, China, March 23, 2022, CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T cell therapies for the treatment of hematologic malignancies and solid tumors, today announced that CT041, an autologous CAR T-cell product candidate against the protein Claudin18.2 (CLDN18.2), has completed the first patient enrollment in the confirmatory Phase II clinical trial in Beijing Cancer Hospital in China for the treatment of CLDN18.2 positive advanced gastric/gastroesophageal junction cancer (GC/GEJ) in patients who have failed at least 2 prior lines of therapies.

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  • CARsgen 2021 Annual Results: Steady Advancement in Innovative CAR T Products and Technologies

    SHANGHAI, China, March 22, 2022, CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T cell therapies for the treatment of hematologic malignancies and solid tumors, announced its 2021 Annual Results.

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  • Claudin18.2 CAR T Cells (CT041) Receives Approval to Initiate A Confirmatory Phase II Clinical Trial for advanced GC/GEJ in China

    SHANGHAI, March 3, 2022 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T cell therapies for the treatment of hematologic malignancies and solid tumors, today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China has approved the initiation of the CT041 confirmatory Phase II clinical trial for the treatment of patients with Claudin18.2 (CLDN18.2) positive advanced gastric /gastroesophageal junction cancer (GC/GEJ) who have failed at least 2 prior lines of systemic therapies. The trial aims to evaluate the efficacy and safety of CT041 for the treatment of advanced GC/GEJ.

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  • CARsgen Therapeutics Opens New U.S. cGMP Facility for CAR T Production

    DURHAM, RALEIGH and CHAPEL HILL, N.C., Feb. 21, 2022, CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies announced that its current Good Manufacturing Practices (cGMP) manufacturing facility located at the Research Triangle Park (RTP) in North Carolina, the United States of America (“The RTP Manufacturing Facility”) has successfully passed the official inspections by local government. CARsgen has received the Certificate of Compliance from the City-County Inspections Department of Durham, enabling CARsgen to advance to clinical manufacturing.

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  • CARsgen Appoints Richard John Daly as the President of CARsgen Therapeutics Corporation

    SHANGHAI and DURHAM, Jan. 17, 2021 -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company mainly focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announced today the appointment of Richard John Daly (“Mr. Daly”) as the President of CARsgen Therapeutics Corporation, a subsidiary of the Company in the United States. Mr. Daly will report to Dr. Zonghai Li, Founder, Chairman of the Board, CEO, CSO of CARsgen Therapeutics Holdings Limited.

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  • CARsgen Announces CT041 CAR T-cell Product Candidate Granted RMAT Designation by the FDA

    SHANGHAI, Jan. 10, 2022 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company mainly focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, today announced that the United States Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to CT041 for the treatment of patients who have advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) with Claudin18.2-positive tumor. CT041 is the first CAR T-cell product candidate against solid tumor with RMAT designation*, according to public resources.

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  • CARsgen Announces First Patient Enrollment in the Confirmatory Phase II Clinical Trial of CT041 in China

    SHANGHAI, China, March 23, 2022, CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T cell therapies for the treatment of hematologic malignancies and solid tumors, today announced that CT041, an autologous CAR T-cell product candidate against the protein Claudin18.2 (CLDN18.2), has completed the first patient enrollment in the confirmatory Phase II clinical trial in Beijing Cancer Hospital in China for the treatment of CLDN18.2 positive advanced gastric/gastroesophageal junction cancer (GC/GEJ) in patients who have failed at least 2 prior lines of therapies.

    Read More
  • CARsgen 2021 Annual Results: Steady Advancement in Innovative CAR T Products and Technologies

    SHANGHAI, China, March 22, 2022, CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T cell therapies for the treatment of hematologic malignancies and solid tumors, announced its 2021 Annual Results.

    Read More
  • Claudin18.2 CAR T Cells (CT041) Receives Approval to Initiate A Confirmatory Phase II Clinical Trial for advanced GC/GEJ in China

    SHANGHAI, March 3, 2022 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T cell therapies for the treatment of hematologic malignancies and solid tumors, today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China has approved the initiation of the CT041 confirmatory Phase II clinical trial for the treatment of patients with Claudin18.2 (CLDN18.2) positive advanced gastric /gastroesophageal junction cancer (GC/GEJ) who have failed at least 2 prior lines of systemic therapies. The trial aims to evaluate the efficacy and safety of CT041 for the treatment of advanced GC/GEJ.

    Read More
  • CARsgen Therapeutics Opens New U.S. cGMP Facility for CAR T Production

    DURHAM, RALEIGH and CHAPEL HILL, N.C., Feb. 21, 2022, CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies announced that its current Good Manufacturing Practices (cGMP) manufacturing facility located at the Research Triangle Park (RTP) in North Carolina, the United States of America (“The RTP Manufacturing Facility”) has successfully passed the official inspections by local government. CARsgen has received the Certificate of Compliance from the City-County Inspections Department of Durham, enabling CARsgen to advance to clinical manufacturing.

    Read More
  • CARsgen Appoints Richard John Daly as the President of CARsgen Therapeutics Corporation

    SHANGHAI and DURHAM, Jan. 17, 2021 -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company mainly focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announced today the appointment of Richard John Daly (“Mr. Daly”) as the President of CARsgen Therapeutics Corporation, a subsidiary of the Company in the United States. Mr. Daly will report to Dr. Zonghai Li, Founder, Chairman of the Board, CEO, CSO of CARsgen Therapeutics Holdings Limited.

    Read More
  • CARsgen Announces CT041 CAR T-cell Product Candidate Granted RMAT Designation by the FDA

    SHANGHAI, Jan. 10, 2022 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company mainly focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, today announced that the United States Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to CT041 for the treatment of patients who have advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) with Claudin18.2-positive tumor. CT041 is the first CAR T-cell product candidate against solid tumor with RMAT designation*, according to public resources.

    Read More
  • CARsgen Therapeutics Opens New U.S. cGMP Facility for CAR T Production

    DURHAM, RALEIGH and CHAPEL HILL, N.C., Feb. 21, 2022, CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies announced that its current Good Manufacturing Practices (cGMP) manufacturing facility located at the Research Triangle Park (RTP) in North Carolina, the United States of America (“The RTP Manufacturing Facility”) has successfully passed the official inspections by local government. CARsgen has received the Certificate of Compliance from the City-County Inspections Department of Durham, enabling CARsgen to advance to clinical manufacturing.

    Read More
  • CARsgen Appoints Richard John Daly as the President of CARsgen Therapeutics Corporation

    SHANGHAI and DURHAM, Jan. 17, 2021 -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company mainly focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announced today the appointment of Richard John Daly (“Mr. Daly”) as the President of CARsgen Therapeutics Corporation, a subsidiary of the Company in the United States. Mr. Daly will report to Dr. Zonghai Li, Founder, Chairman of the Board, CEO, CSO of CARsgen Therapeutics Holdings Limited.

    Read More
  • CARsgen Announces CT041 CAR T-cell Product Candidate Granted RMAT Designation by the FDA

    SHANGHAI, Jan. 10, 2022 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company mainly focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, today announced that the United States Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to CT041 for the treatment of patients who have advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) with Claudin18.2-positive tumor. CT041 is the first CAR T-cell product candidate against solid tumor with RMAT designation*, according to public resources.

    Read More
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