Shanghai Fosun Pharmaceutical (600196.SH): Two injectable products of Denosumab have received approval for registration in the European Union.

Shanghai Fosun Pharmaceutical (600196.SH) announced that its controlling subsidiary, Shanghai HENLIUS Biotech Co., Ltd. (hereinafter referred to as "HENLIUS") and its controlling subsidiary have obtained approval from the European Commission for the marketing authorization applications (MAAs) of BILDYOS (60 mg/mL) and BILPREVDA (120 mg/1.7mL), two denosumab injection products independently developed by the company (project code: HLX14). As a result, BILDYOS and BILPREVDA have obtained centralized marketing authorization in all European Union member states as well as Iceland, Liechtenstein, and Norway (respectively European Economic Area countries). HLX14 is a denosumab biosimilar drug developed independently by the group, intended for the treatment of postmenopausal women at high risk of fractures with osteoporosis and/or other indications consistent with the reference drug label.