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復星醫藥:海外監管公告 - 關於控股子公司獲藥品註冊申請受理的公告

FOSUN PHARMA: Overseas Regulatory Announcement - Announcement on the acceptance of pharmaceutical registration applications by subsidiary companies.

HKEX ·  Dec 4 17:56

Summary by Futu AI

2024年12月4日,复星医药宣布其控股子公司复宏汉霖自主研发的帕妥珠单抗生物类似药HLX11的药品注册申请已获国家药品监督管理局受理。该新药拟用于HER2阳性乳腺癌患者的辅助治疗和转移性乳腺癌患者的治疗。2024年9月,该新药在国际多中心III期临床研究中达到了主要研究终点。截至2024年10月,复星医药在该新药的研发上累计投入约人民币18,377万元。根据IQVIA CHPA数据,2023年帕妥珠单抗注射液在中国的销售额约为人民币34亿元。尽管注册申请已获受理,但新药在商业化生产前仍需通过GMP符合性检查和获得药品注册批准。复星医药提醒投资者,由于医药产品的行业特点,药品上市后的销售情况可能受到用药需求、市场竞争和销售渠道等因素影响,具有较大不确定性。因此,本次注册申请受理不会对公司现阶段业绩产生重大影响。
2024年12月4日,复星医药宣布其控股子公司复宏汉霖自主研发的帕妥珠单抗生物类似药HLX11的药品注册申请已获国家药品监督管理局受理。该新药拟用于HER2阳性乳腺癌患者的辅助治疗和转移性乳腺癌患者的治疗。2024年9月,该新药在国际多中心III期临床研究中达到了主要研究终点。截至2024年10月,复星医药在该新药的研发上累计投入约人民币18,377万元。根据IQVIA CHPA数据,2023年帕妥珠单抗注射液在中国的销售额约为人民币34亿元。尽管注册申请已获受理,但新药在商业化生产前仍需通过GMP符合性检查和获得药品注册批准。复星医药提醒投资者,由于医药产品的行业特点,药品上市后的销售情况可能受到用药需求、市场竞争和销售渠道等因素影响,具有较大不确定性。因此,本次注册申请受理不会对公司现阶段业绩产生重大影响。
On December 4, 2024, Fosun Pharma announced that its controlling subsidiary, Henlius, had its independently developed biosimilar HLX11 monoclonal antibody drug registration application accepted by the National Medical Products Administration. The new drug is intended for the adjuvant treatment of HER2-positive breast cancer patients and the treatment of metastatic breast cancer patients. In September 2024, the new drug achieved the primary endpoint in an international multicenter Phase III clinical trial. As of October 2024, Fosun Pharma has accumulated approximately RMB 183.77 million in research and development of this new drug. According to IQVIA CHPA data, in 2023, the sales of Pertuzumab injection in China amounted to approximately RMB 3.4 billion. Despite the acceptance of the registration application, the new drug still needs to pass Good Manufacturing Practice (GMP...Show More
On December 4, 2024, Fosun Pharma announced that its controlling subsidiary, Henlius, had its independently developed biosimilar HLX11 monoclonal antibody drug registration application accepted by the National Medical Products Administration. The new drug is intended for the adjuvant treatment of HER2-positive breast cancer patients and the treatment of metastatic breast cancer patients. In September 2024, the new drug achieved the primary endpoint in an international multicenter Phase III clinical trial. As of October 2024, Fosun Pharma has accumulated approximately RMB 183.77 million in research and development of this new drug. According to IQVIA CHPA data, in 2023, the sales of Pertuzumab injection in China amounted to approximately RMB 3.4 billion. Despite the acceptance of the registration application, the new drug still needs to pass Good Manufacturing Practice (GMP) compliance checks and obtain drug registration approval before commercial production. Fosun Pharma reminds investors that due to the industry characteristics of pharmaceutical products, the sales performance after the drug's market launch may be affected by factors such as medication demand, market competition, and sales channels, with significant uncertainty. Therefore, the acceptance of this registration application will not have a significant impact on the company's current performance.

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