On March 19, 2025, Shanghai Henlius Biotech announced that the FDA has granted Orphan Drug Designation for HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer. HLX22 binds to HER2 extracellular subdomain IV at a different binding site than trastuzumab, another anti-HER2 antibody. According to Henlius, “[i]n addition…