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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, 2024 17:53

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, Fossil Pharmaceuticals announced that Hansel® (Srulline anti-injection solution), independently developed by its holding subsidiary, Fauhong Hanlin, has received approval from the National Drug Administration for the treatment of local late or metastatic non-small cell lung cancer with non-surgical removal of EGFR gene mutations in genital and ALK vaginal (NSF) CLC). This approval will increase market competition for the drug and provide patients with more treatment options.HANS® IS AN INNOVATIVE ANTI-PD-1 MONOANTIDOTE DEVELOPED BY APOSTAR PHARMACEUTICALS. IT HAS RECEIVED MULTIPLE PRESCRIPTIONS IN CHINA AND RECEIVED CRITICAL REVIEWS IN THE EUROPEAN UNION. By October 2024, Foshan Pharmaceutical invested about RMB 28.68 yuan in the research and development of the drug. According to IQVIA data, global sales of...Show More
On December 3, 2024, Fossil Pharmaceuticals announced that Hansel® (Srulline anti-injection solution), independently developed by its holding subsidiary, Fauhong Hanlin, has received approval from the National Drug Administration for the treatment of local late or metastatic non-small cell lung cancer with non-surgical removal of EGFR gene mutations in genital and ALK vaginal (NSF) CLC). This approval will increase market competition for the drug and provide patients with more treatment options.HANS® IS AN INNOVATIVE ANTI-PD-1 MONOANTIDOTE DEVELOPED BY APOSTAR PHARMACEUTICALS. IT HAS RECEIVED MULTIPLE PRESCRIPTIONS IN CHINA AND RECEIVED CRITICAL REVIEWS IN THE EUROPEAN UNION. By October 2024, Foshan Pharmaceutical invested about RMB 28.68 yuan in the research and development of the drug. According to IQVIA data, global sales of the PD-1 single antidote in 2023 are estimated at US$399, and the Chinese market is about US$81.Although the approval of the new prescription has increased market competitiveness, there are still uncertainties in the post-market sales of the drug, influenced by market demand, competition and other factors. Investors should be aware of the risks involved.

This announcement is a separate document:

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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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