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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批准的公告

FOSUN PHARMA: Overseas Regulatory Announcement - Announcement regarding the pharmaceutical registration approval obtained by a subsidiary.

HKEX ·  Dec 3 10:53

Summary by Moomoo AI

2024年12月3日，复星医药宣布其控股子公司复宏汉霖自主研发的汉斯状®（斯鲁利单抗注射液）获得国家药监局批准，用于治疗EGFR基因突变阴性和ALK阴性的不可手术切除的局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）。此次批准将增强该药品的市场竞争力，为患者提供更多治疗选择。汉斯状®是复星医药自主研发的创新型抗PD-1单抗，已在中国获批多种适应症，并在欧盟获得积极审评意见。至2024年10月，复星医药在该药品的研发投入约为人民币28.68亿元。根据IQVIA数据，2023年全球PD-1单抗药品销售额约为399亿美元，中国市场销售额约为81亿元。尽管新适应症的获批提升了市场竞争力，但药品上市后的销售情况仍存在不确定性，受市场需求、竞争环境等因素影响。投资者需注意相关风险。
2024年12月3日，复星医药宣布其控股子公司复宏汉霖自主研发的汉斯状®（斯鲁利单抗注射液）获得国家药监局批准，用于治疗EGFR基因突变阴性和ALK阴性的不可手术切除的局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）。此次批准将增强该药品的市场竞争力，为患者提供更多治疗选择。汉斯状®是复星医药自主研发的创新型抗PD-1单抗，已在中国获批多种适应症，并在欧盟获得积极审评意见。至2024年10月，复星医药在该药品的研发投入约为人民币28.68亿元。根据IQVIA数据，2023年全球PD-1单抗药品销售额约为399亿美元，中国市场销售额约为81亿元。尽管新适应症的获批提升了市场竞争力，但药品上市后的销售情况仍存在不确定性，受市场需求、竞争环境等因素影响。投资者需注意相关风险。
On December 3, 2024, Fosun Pharma announced that its controlling subsidiary Fuhong Hanlin's independently developed Hansify® (Sulilumab Injection) has been approved by the National Medical Products Administration for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that is not surgically resectable and is negative for EGFR gene mutations and ALK. This approval will enhance the market competitiveness of the drug and provide more treatment options for patients. Hansify® is an innovative anti-PD-1 monoclonal antibody independently developed by Fosun Pharma, with multiple indications approved in China and receiving positive opinions for review in the European Union. By October 2024, Fosun Pharma's research and development investment in the drug was approximately RMB 2.868 billion. According to...Show More
On December 3, 2024, Fosun Pharma announced that its controlling subsidiary Fuhong Hanlin's independently developed Hansify® (Sulilumab Injection) has been approved by the National Medical Products Administration for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that is not surgically resectable and is negative for EGFR gene mutations and ALK. This approval will enhance the market competitiveness of the drug and provide more treatment options for patients. Hansify® is an innovative anti-PD-1 monoclonal antibody independently developed by Fosun Pharma, with multiple indications approved in China and receiving positive opinions for review in the European Union. By October 2024, Fosun Pharma's research and development investment in the drug was approximately RMB 2.868 billion. According to IQVIA data, the global sales of PD-1 monoclonal antibody drugs were approximately USD 39.9 billion in 2023, with sales in the Chinese market around RMB 8.1 billion. Despite the enhanced market competitiveness from the approval of new indications, there is still uncertainty in sales performance after the drug is launched, influenced by factors such as market demand and competitive environment. Investors should be aware of relevant risks.

This announcement is a separate document:

Doc 1

Disclaimer: This content is for informational and educational purposes only and does not constitute a recommendation or endorsement of any specific investment or investment strategy. Read more
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