China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that it has received orphan drug designation (ODD) from the European Commission (EC) for HLX22, an HER2-targeted monoclonal antibody (mAb) licensed from AbClon, Inc. This designation is for the treatment of gastric cancer (GC). Earlier this year in March, HLX22 was also granted ODD for the same indication in the US.

Clinical Trial Progress
HLX22 is currently undergoing multiple Phase II and global multi-center Phase III clinical trials. The Phase I study in China has been completed, marking a significant step in the drug’s development.-Fineline Info & Tech