Ge Long Hui A P P·2025-09-01 11:32Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., received FDA approval for its biosimilar HLX14, which is intended for the treatment of osteoporosis in postmenopausal women at high risk of fractures [1] Group 1: Product Approval and Specifications - HLX14 is a biosimilar of denosumab, with two specifications: 60mg/mL and 120mg/1.7mL [1] - The FDA approval allows HLX14 to be used for treating osteoporosis in postmenopausal women and other indications consistent with the reference drug's label [1] Group 2: Regulatory Progress in Other Regions - In May 2024, HLX14's marketing authorization application (MAA) will be accepted by the European Medicines Agency (EMA), with a positive review opinion expected by July 2025 [1] - In September 2024, HLX14's new drug submission (NDS) will be accepted by Health Canada [1]