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中國生物製藥：自願公告 - KRAS G12C抑制劑「GARSORASIB（D-1553片）」II期臨床研究數據將在2024 AACR公佈

SINO BIOPHARM: VOLUNTARY ANNOUNCEMENT - DATA OF PHASE II CLINICAL STUDY OF KRAS G12C INHIBITOR "GARSORASIB TABLET (D-1553)" WILL BE PRESENTED AT 2024 AACR

香港交易所 ·  Mar 13 16:34
Summary by Futu AI
中國生物製藥有限公司宣佈，其聯合開發的KRAS G12C抑制劑「Garsorasib（D-1553片）」的II期臨床研究數據將於2024年在美國癌症協會年會（AACR）公佈。該藥物用於治療KRAS G12C突變的非小細胞肺癌患者，並已於2022年6月被中國國家藥品監督管理局藥品審評中心納入突破性治療藥物程序。2024年1月，Garsorasib向CDE遞交上市申請並獲得受理。目前，Garsorasib正在進行單藥和聯合用藥在非小細胞肺癌一線治療以及結直腸癌等其他實體腫瘤中的國際多中心臨床研究。2023年8月，中國生物製藥的附屬公司正大天晴藥業集團與益方生物科技簽署獨家許可與合作協議，正大天晴獲得Garsorasib在中國大陸地區的獨家開發、註冊、生產和商業化權限。
中國生物製藥有限公司宣佈，其聯合開發的KRAS G12C抑制劑「Garsorasib（D-1553片）」的II期臨床研究數據將於2024年在美國癌症協會年會（AACR）公佈。該藥物用於治療KRAS G12C突變的非小細胞肺癌患者，並已於2022年6月被中國國家藥品監督管理局藥品審評中心納入突破性治療藥物程序。2024年1月，Garsorasib向CDE遞交上市申請並獲得受理。目前，Garsorasib正在進行單藥和聯合用藥在非小細胞肺癌一線治療以及結直腸癌等其他實體腫瘤中的國際多中心臨床研究。2023年8月，中國生物製藥的附屬公司正大天晴藥業集團與益方生物科技簽署獨家許可與合作協議，正大天晴獲得Garsorasib在中國大陸地區的獨家開發、註冊、生產和商業化權限。
China Biopharmaceuticals Limited announced that Phase II clinical trial data of its jointly developed KRAS G12C inhibitor “Garsorasib (D-1553 tablets)” will be announced at the American Cancer Society Annual Meeting (AACR) in 2024. The drug is used to treat patients with non-small cell lung cancer with KRAS G12C mutation and was included in the breakthrough therapeutic drug program by the Drug Review Center of the China National Drug Administration in June 2022. In January 2024, Garsorasib submitted a listing application to the CDE and was accepted. Currently, Garsorasib is undergoing an international multi-center clinical trial in single-drug and combination therapy in first-line treatment of non-small cell lung cancer and other solid tumors such as colorectal cancer. In August 2023, a subsidiary of China Biopharmaceuticals, Cheng Daitanqing Pharmaceutical Group, signed an exclusive license and cooperation agreement with Benefactor Biotechnology, and Zheng Dai Tian Ching obtained exclusive development, registration, production and commercialization rights for Garsorasib in mainland China.
China Biopharmaceuticals Limited announced that Phase II clinical trial data of its jointly developed KRAS G12C inhibitor “Garsorasib (D-1553 tablets)” will be announced at the American Cancer Society Annual Meeting (AACR) in 2024. The drug is used to treat patients with non-small cell lung cancer with KRAS G12C mutation and was included in the breakthrough therapeutic drug program by the Drug Review Center of the China National Drug Administration in June 2022. In January 2024, Garsorasib submitted a listing application to the CDE and was accepted. Currently, Garsorasib is undergoing an international multi-center clinical trial in single-drug and combination therapy in first-line treatment of non-small cell lung cancer and other solid tumors such as colorectal cancer. In August 2023, a subsidiary of China Biopharmaceuticals, Cheng Daitanqing Pharmaceutical Group, signed an exclusive license and cooperation agreement with Benefactor Biotechnology, and Zheng Dai Tian Ching obtained exclusive development, registration, production and commercialization rights for Garsorasib in mainland China.
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