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 to treating HER2-positive gastric cancer, the therapeutic scope of HLX22 has been further expanded to the field of breast cancer, potentially providing new treatment options for more patients.” According to the FDA, orphan drug designation qualifies sponsors for incentives, including tax credits for qualified clinical trials, exemption from user fees, and potential seven years of market exclusivity after FDA approval.
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