Shanghai Fosun Pharmaceutical (Group) Co., Ltd.: Production facilities related to HLX11 and HLX14 successfully pass GMP certification in an EU member state for the first time

Fosun Pharma (600196.SH) announced that its subsidiary, Shanghai Henlius Biologics Co., Ltd., recently received the "Certificate of GMP Compliance of a Manufacturer" from the Belgian Federal Agency for Medicines and Health Products for the manufacturing facilities related to HLX11 (recombinant anti-HER2 domain II humanized monoclonal antibody injection, i.e., pertuzumab injection) and HLX14 (recombinant anti-RANKL fully human monoclonal antibody injection, i.e., denosumab biosimilar injection).

This marks the first time that the manufacturing facilities related to HLX11 and HLX14 have passed GMP certification from an EU member state. Under the mutual recognition system for GMP among EU member states, passing GMP certification in Belgium indicates that these manufacturing facilities now comply with EU GMP standards.