Fosun Pharma (02696): The biosimilar drug HLX14 (recombinant anti-RANKL human monoclonal antibody injection) for denosumab received positive review from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

Tencent Finance APP News, Fuhong Hanlin (02696) announced that recently, HLX14 received a positive evaluation opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending approval of the market authorization application for HLX14. The evaluation opinion of CHMP will be submitted to the European Commission (EC), and the EC will consider this opinion and make a final review decision in the next 2-3 months. Once approved by the EC, the centralized marketing authorization for HLX14 will take effect in all European Union Member States and European Economic Area (EEA) countries Iceland, Liechtenstein, and Norway.