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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 18:00

Summary by Futu 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。
Fosun Pharma, a subsidiary of Fosun Pharmaceutical, recently received approval from the National Medical Products Administration to conduct a Phase II clinical trial of HLX22 combined with trastuzumab and chemotherapy. HLX22 is a targeted monoclonal antibody for HER2, planned for the treatment of solid tumors such as gastric cancer and breast cancer. This new drug has completed Phase I clinical research in China and is conducting Phase III clinical trials internationally. By October 2024, Fosun Pharma's research and development investment in this treatment plan is approximately 105 million yuan. According to IQVIA CHPA data, the sales of HER2-targeted monoclonal antibody products in China were about 9.5 billion yuan in 2023. Fosun Pharma plans to conduct the Phase II clinical trial of this new drug in China...Show More
Fosun Pharma, a subsidiary of Fosun Pharmaceutical, recently received approval from the National Medical Products Administration to conduct a Phase II clinical trial of HLX22 combined with trastuzumab and chemotherapy. HLX22 is a targeted monoclonal antibody for HER2, planned for the treatment of solid tumors such as gastric cancer and breast cancer. This new drug has completed Phase I clinical research in China and is conducting Phase III clinical trials internationally. By October 2024, Fosun Pharma's research and development investment in this treatment plan is approximately 105 million yuan. According to IQVIA CHPA data, the sales of HER2-targeted monoclonal antibody products in China were about 9.5 billion yuan in 2023. Fosun Pharma plans to conduct the Phase II clinical trial of this new drug in China once conditions are met. However, due to the risks inherent in new drug research and development, clinical trials may be terminated due to safety or efficacy issues. The market launch of new drugs requires a series of clinical studies and approvals, which involves uncertainty. Investors need to pay attention to related risks.

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