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  • CARsgen Announces Collaboration Agreement to Evaluate AB011 in Combination with PD-L1 Checkpoint Inhibitor to Treat Gastric Cancer

    SHANGHAI, January 31st, 2023 — CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative therapies for the treatment of hematologic malignancies and solid tumors, has announced CARsgen’s execution of a collaboration agreement with F. Hoffmann-La Roche Ltd (“Roche”) to evaluate CARsgen’s investigational drug AB011, the first humanized monoclonal antibody against Claudin18.2 (CLDN18.2) that received IND clearance globally, in combination with atezolizumab, Roche’s PD-L1 checkpoint inhibitor, along with standard-of-care chemotherapy in patients with gastric or gastroesophageal junction carcinoma . Under the terms of the agreement, Roche will be responsible for operation and conduct of the trial while both companies co-share the costs of the AB011 treatment arms in the study. As part of the clinical collaboration, CARsgen’s proprietary CLDN18.2 IHC test kit, which has showed excellent specificity and sensitivity profiles, will be applied to evaluate CLDN18.2 expression in the gastric cancer patients.

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  • CARsgen Presents Results on Anti-Claudin18.2-mAb AB011 at ASCO GI

    SHANGHAI, January 20, 2023 — 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 a poster presentation highlighting the Phase 1 preliminary results of a recombinant humanized anti-claudin18.2 monoclonal antibody (AB011), as monotherapy and combination therapy, for patients with advanced solid tumors was presented at the 2023 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (“ASCO GI”), in San Francisco, California, during January 19-21, 2023.

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  • CARsgen Therapeutics and Huadong Medicine Announce Collaboration Agreement For Zevorcabtagene Autoleucel In Mainland China

    SHANGHAI, January 16, 2023 — CARsgen Therapeutics Holdings Limited (2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, and Huadong Medicine (Hangzhou) Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (Huadong Medicine; SZ: 000963),today announced a collaboration for the commercialization of CARsgen’s BCMA CAR-T product CT053 in mainland China.

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  • Results of a Collaborative Research on CAR T Technology between CARsgen and Shanghai Cancer Institute Published on Molecular Therapy

     SHANGHAI, December 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 Company and the State Key Laboratory of Oncogenes and Related Genes, Shanghai Cancer Institute, have jointly developed a new technology that can significantly increase antitumor activities of T cells. The study was recently published on Molecular Therapy.

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  • CARsgen Presents Data from China Pivotal Phase II Trial of BCMA CAR T Zevor-cel (CT053) at 2022 ASH Annual Meeting

    SHANGHAI, December 12, 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 at the 2022 American Society of Hematology (the “ASH”) Annual Meeting, the Company presented a poster with the results of the phase II LUMMICAR STUDY 1 clinical trial of zevorcabtagene autoleucel (“zevor-cel”, R&D code: CT053, an autologous CAR T-cell product candidate against BCMA) in Chinese patients with relapsed/refractory multiple myeloma (R/R MM). This poster reports for the first time the pivotal phase II safety and efficacy data of LUMMICAR STUDY 1.

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  • CARsgen Appoints Dr. Sylvie Peltier as Senior Vice President of Global Regulatory Affairs

    SHANGHAI, October 31, 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. Sylvie Peltier (“Dr. Peltier”) has been appointed as Senior Vice President of Global Regulatory Affairs of the Company with effect from October 31st, 2022. She will be responsible for developing global regulatory strategies, leading and driving the Company’s regulatory affairs activities, and initiatives in support of IND/CTA/BLA filing and approval of developmental products globally.

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  • CARsgen Announces NDA Acceptance of BCMA CAR T Zevor-cel (CT053) by China NMPA

    SHANGHAI, October 18, 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 National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for zevorcabtagene autoleucel (“zevor-cel,” R&D code: CT053), a fully human, autologous BCMA CAR T-cell therapy for the treatment of relapsed and/or refractory multiple myeloma (R/R MM).

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  • CARsgen Presents North America Phase 2 Updates for CT053 BCMA CAR T at the 7th Annual CAR-TCR Summit

    SHANGHAI, September 21, 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 at the 7th Annual CAR-TCR Summit, in Boston, Massachusetts, the Company gave an oral presentation on the North America Phase 2 clinical trial of zevorcabtagene autoleucel (“zevor-cel”, R&D code: CT053), an autologous CAR T-cell product candidate against BCMA. This multi-center, open-label, Phase 1b/2 study (NCT03915184) is being conducted to evaluate the safety and efficacy in North American patients with relapsed and/or refractory multiple myeloma (R/R MM).

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  • CARsgen Releases the First Clinical Batch of CAR T Cells from its RTP GMP Manufacturing Facility in North Carolina

    SHANGHAI, September 2, 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 company’s Current Good Manufacturing Practice (CGMP) manufacturing facility located at the Research Triangle Park (RTP) in North Carolina, the United States of America (“The RTP GMP Manufacturing Facility”) has started GMP production of autologous CAR T-cell products and successfully released the first GMP batch for the clinical trials.

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  • Results of a Collaborative Research on CAR T Technology between CARsgen and Shanghai Cancer Institute Published on Molecular Therapy

     SHANGHAI, December 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 Company and the State Key Laboratory of Oncogenes and Related Genes, Shanghai Cancer Institute, have jointly developed a new technology that can significantly increase antitumor activities of T cells. The study was recently published on Molecular Therapy.

    Read More
  • CARsgen Presents Data from China Pivotal Phase II Trial of BCMA CAR T Zevor-cel (CT053) at 2022 ASH Annual Meeting

    SHANGHAI, December 12, 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 at the 2022 American Society of Hematology (the “ASH”) Annual Meeting, the Company presented a poster with the results of the phase II LUMMICAR STUDY 1 clinical trial of zevorcabtagene autoleucel (“zevor-cel”, R&D code: CT053, an autologous CAR T-cell product candidate against BCMA) in Chinese patients with relapsed/refractory multiple myeloma (R/R MM). This poster reports for the first time the pivotal phase II safety and efficacy data of LUMMICAR STUDY 1.

    Read More
  • CARsgen Appoints Dr. Sylvie Peltier as Senior Vice President of Global Regulatory Affairs

    SHANGHAI, October 31, 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. Sylvie Peltier (“Dr. Peltier”) has been appointed as Senior Vice President of Global Regulatory Affairs of the Company with effect from October 31st, 2022. She will be responsible for developing global regulatory strategies, leading and driving the Company’s regulatory affairs activities, and initiatives in support of IND/CTA/BLA filing and approval of developmental products globally.

    Read More
  • CARsgen Announces NDA Acceptance of BCMA CAR T Zevor-cel (CT053) by China NMPA

    SHANGHAI, October 18, 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 National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for zevorcabtagene autoleucel (“zevor-cel,” R&D code: CT053), a fully human, autologous BCMA CAR T-cell therapy for the treatment of relapsed and/or refractory multiple myeloma (R/R MM).

    Read More
  • CARsgen Presents North America Phase 2 Updates for CT053 BCMA CAR T at the 7th Annual CAR-TCR Summit

    SHANGHAI, September 21, 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 at the 7th Annual CAR-TCR Summit, in Boston, Massachusetts, the Company gave an oral presentation on the North America Phase 2 clinical trial of zevorcabtagene autoleucel (“zevor-cel”, R&D code: CT053), an autologous CAR T-cell product candidate against BCMA. This multi-center, open-label, Phase 1b/2 study (NCT03915184) is being conducted to evaluate the safety and efficacy in North American patients with relapsed and/or refractory multiple myeloma (R/R MM).

    Read More
  • CARsgen Releases the First Clinical Batch of CAR T Cells from its RTP GMP Manufacturing Facility in North Carolina

    SHANGHAI, September 2, 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 company’s Current Good Manufacturing Practice (CGMP) manufacturing facility located at the Research Triangle Park (RTP) in North Carolina, the United States of America (“The RTP GMP Manufacturing Facility”) has started GMP production of autologous CAR T-cell products and successfully released the first GMP batch for the clinical trials.

    Read More
  • CARsgen Announces NDA Acceptance of BCMA CAR T Zevor-cel (CT053) by China NMPA

    SHANGHAI, October 18, 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 National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for zevorcabtagene autoleucel (“zevor-cel,” R&D code: CT053), a fully human, autologous BCMA CAR T-cell therapy for the treatment of relapsed and/or refractory multiple myeloma (R/R MM).

    Read More
  • CARsgen Presents North America Phase 2 Updates for CT053 BCMA CAR T at the 7th Annual CAR-TCR Summit

    SHANGHAI, September 21, 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 at the 7th Annual CAR-TCR Summit, in Boston, Massachusetts, the Company gave an oral presentation on the North America Phase 2 clinical trial of zevorcabtagene autoleucel (“zevor-cel”, R&D code: CT053), an autologous CAR T-cell product candidate against BCMA. This multi-center, open-label, Phase 1b/2 study (NCT03915184) is being conducted to evaluate the safety and efficacy in North American patients with relapsed and/or refractory multiple myeloma (R/R MM).

    Read More
  • CARsgen Releases the First Clinical Batch of CAR T Cells from its RTP GMP Manufacturing Facility in North Carolina

    SHANGHAI, September 2, 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 company’s Current Good Manufacturing Practice (CGMP) manufacturing facility located at the Research Triangle Park (RTP) in North Carolina, the United States of America (“The RTP GMP Manufacturing Facility”) has started GMP production of autologous CAR T-cell products and successfully released the first GMP batch for the clinical trials.

    Read More
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