Fosun Pharma's HLX22 receives FDA orphan drug designation

Shanghai Fosun Pharmaceutical Group (SSE:600196) announced today that its subsidiary, Henlius USA Inc., has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for HLX22 (recombinant humanized anti-HER2 monoclonal antibody injection) in the treatment of gastric cancer (GC). HLX22 is a novel anti-HER2 monoclonal antibody being developed for gastric and breast cancers. Clinical trials for HLX22 are ongoing in China and internationally. The Orphan Drug Designation grants several benefits, including tax credits for clinical trial costs, exemption from new drug application fees, and seven years of market exclusivity upon approval. As of February 2025, Fosun Pharma has invested approximately RMB 304 million in the research and development of HLX22 (monotherapy). The market for anti-HER2 monoclonal antibody products was approximately $9.029 billion globally in 2024.