复星医药:控股子公司地舒单抗生物类似药HLX14获国家药监局受理
Hua Er Jie Jian Wen·2025-12-02 15:17

Core Points - The subsidiary of Fosun Pharma, Fuhong Hanlin, has received acceptance for the drug registration application of the biosimilar HLX14, a drug similar to Dexamethasone, by the National Medical Products Administration [1] - The application is classified as a Class 3.3 therapeutic biological product, with indications based on all approved indications of the reference drug Prolia in China [1] Product Information - HLX14 has been approved for marketing in the United States, European Union, and the United Kingdom, covering all indications of the original product [1] - The application for marketing registration was accepted by Health Canada in September 2024 [1] - Cumulative R&D investment is approximately 320 million yuan (unaudited) as of October 2025 [1] Market Outlook - According to IQVIA data, the global sales of Dexamethasone products are projected to be approximately 7.463 billion USD in 2024 [1]

FOSUNPHARMA-复星医药:控股子公司地舒单抗生物类似药HLX14获国家药监局受理 - Reportify