格隆汇12月2日丨复星医药(02196.HK)近日，上海复星医药(集团)股份有限公司控股子公司上海复宏汉 霖生物技术股份有限公司及其控股子公司自主研发的地舒单抗生物类似药HLX14(即重组抗RANKL全人 单克隆抗体注射液，申请注册分类：治疗用生物制品3.3类；以下简称"HLX14")的药品注册申请获国家 药品监督管理局受理。本次申报适应症为其参照药普罗力®(英文商品名：Prolia®)于中国境内已获批上 市的所有适应症。 ...

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]