复星医药(600196.SH)控股子公司获美国FDA药品注册批准

Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received FDA approval for its biosimilar drug HLX14, which is intended for the treatment of osteoporosis in postmenopausal women at high risk of fractures [1] Group 1 - The FDA approved the biologics license application (BLA) for HLX14, which comes in two specifications: 60mg/mL and 120mg/1.7mL [1] - HLX14 is a biosimilar of denosumab, developed by the company and its subsidiaries [1] - The drug is aimed at treating osteoporosis and other indications consistent with the reference drug's label [1]