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帕妥珠单抗注射液(HLX11)
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复星医药:控股子公司获欧盟药品GMP证书
news flash· 2025-07-02 08:24
Core Viewpoint - Fosun Pharma's subsidiary has received EU GMP certification for two injectable drugs, which may enhance its market position but has uncertain sales impacts [1] Group 1: Company Announcement - Fosun Pharma announced that its subsidiary, Shanghai Fuhong Hanlin Biopharmaceutical Co., Ltd., received the GMP certificate from the Belgian Federal Agency for Medicines and Health Products [1] - The certified products are Pertuzumab injection (HLX11) and Dexamethasone injection (HLX14) [1] Group 2: Financial Implications - The total investment in the production facilities related to this GMP certification is approximately RMB 235.82 million [1] - The projected global sales for Pertuzumab injection in 2024 are about USD 3.322 billion, while for Dexamethasone injection, it is approximately USD 7.462 billion [1] - The GMP certification is not expected to have a significant impact on the company's current performance, and the sales of the drugs may be influenced by various uncertain factors [1]