Shanghai Fosun Pharmaceutical (Group) Co.,Ltd. (600196.SH) announced that its controlling subsidiary Shanghai Henlius Biotech Co., Ltd. ("Henlius") and its subsidiary have recently received approval from the European Commission for the Marketing Authorization Applications (MAAs) of two self-developed denosumab injection products: BILDYOS® (60 mg/mL) and BILPREVDA® (120 mg/1.7mL), under project code HLX14.

Following this approval, BILDYOS® and BILPREVDA® have obtained centralized marketing authorization across all European Union member states, as well as in Iceland, Liechtenstein, and Norway (European Economic Area countries).

HLX14 is a self-developed denosumab biosimilar drug by the Group, intended for the treatment of osteoporosis in postmenopausal women at high risk of fractures and/or other indications consistent with the reference drug's labeling.