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復星醫藥：海外監管公告 - 關於控股子公司獲藥品臨床試驗批准的公告

FOSUN PHARMA: Overseas Regulatory Announcement - Announcement Regarding Subsidiary's Approval for Pharmaceutical Clinical Trials

HKEX ·  Dec 4, 2024 05:00

Summary by Moomoo AI

上海复星医药控股子公司复宏汉霖近日获得国家药品监督管理局批准，开展HLX22联合曲妥珠单抗和化疗的II期临床试验。HLX22是一种靶向HER2的单克隆抗体，计划用于治疗胃癌和乳腺癌等实体瘤。该新药已在中国完成I期临床研究，并在国际上开展III期临床试验。截至2024年10月，复星医药在该治疗方案上的研发投入约为人民币1.05亿元。根据IQVIA CHPA数据，2023年靶向HER2的单抗产品在中国的销售额约为人民币95亿元。复宏汉霖计划在条件具备后于中国境内开展该新药的II期临床试验。然而，因為新药研发存在风险，临床试验可能因安全性或有效性问题而终止。新药上市需经过一系列临床研究和审批，存在不确定性。投资者需注意相关风险。
上海复星医药控股子公司复宏汉霖近日获得国家药品监督管理局批准，开展HLX22联合曲妥珠单抗和化疗的II期临床试验。HLX22是一种靶向HER2的单克隆抗体，计划用于治疗胃癌和乳腺癌等实体瘤。该新药已在中国完成I期临床研究，并在国际上开展III期临床试验。截至2024年10月，复星医药在该治疗方案上的研发投入约为人民币1.05亿元。根据IQVIA CHPA数据，2023年靶向HER2的单抗产品在中国的销售额约为人民币95亿元。复宏汉霖计划在条件具备后于中国境内开展该新药的II期临床试验。然而，因為新药研发存在风险，临床试验可能因安全性或有效性问题而终止。新药上市需经过一系列临床研究和审批，存在不确定性。投资者需注意相关风险。
Shanghai Foshan Lin, a subsidiary of Fujian Pharmaceutical Holdings, recently received approval from the National Drug Administration for Drug Administration to conduct phase II clinical trials of HLX22 combined anticonvulsant and chemotherapy. HLX22 is a monoclonal antibody targeting HER2 and is being used to treat somatomas such as gastric cancer and breast cancer. The new drug has completed Phase I clinical trials in China and a Phase III clinical trial has been launched internationally.As of October 2024, Foshan Pharmaceuticals invested about RMB 1.05 yuan in the research and development of this treatment program. According to IQVIA CHPA data, sales of a single anti-HER2-targeted product in China in 2023 are estimated to be RMB 95 yuan. Fu Hung Hanlin plans to conduct phase II clinical trials...Show More
Shanghai Foshan Lin, a subsidiary of Fujian Pharmaceutical Holdings, recently received approval from the National Drug Administration for Drug Administration to conduct phase II clinical trials of HLX22 combined anticonvulsant and chemotherapy. HLX22 is a monoclonal antibody targeting HER2 and is being used to treat somatomas such as gastric cancer and breast cancer. The new drug has completed Phase I clinical trials in China and a Phase III clinical trial has been launched internationally.As of October 2024, Foshan Pharmaceuticals invested about RMB 1.05 yuan in the research and development of this treatment program. According to IQVIA CHPA data, sales of a single anti-HER2-targeted product in China in 2023 are estimated to be RMB 95 yuan. Fu Hung Hanlin plans to conduct phase II clinical trials of the new drug in China after conditions are met.However, due to risks of new drug development, clinical trials may be terminated due to safety or efficacy issues. The introduction of a new drug is subject to a series of clinical studies and approvals, and there is uncertainty. Investors should be aware of the risks involved.

This announcement is a separate document:

Doc 1

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