复星医药HLX14药品注册申请获受理

Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has had its drug registration application for the biosimilar HLX14 accepted by the National Medical Products Administration of China, targeting all indications approved for the reference drug Prolia in mainland China [1] Group 1 - The drug HLX14 is a biosimilar to Prolia, which has already been approved for marketing in the US, EU, and UK [1] - The application for HLX14 covers all indications that Prolia has been approved for in China, excluding Hong Kong, Macau, and Taiwan [1] - Two products under HLX14, BILDYOS and BILPREVDA, have received approval in the aforementioned regions, aligning with the indications of their reference products Prolia and XGEVA [1]