Henlius' HLX22 receives European orphan-drug designation for gastric cancer

Shanghai Henlius Biotech, Inc. (HKEX: 2696) announced that its controlling subsidiary, Henlius Europe GmbH, has received Orphan-Drug Designation from the European Commission (EC) for HLX22, a recombinant humanized anti-HER2 monoclonal antibody injection, in the treatment of gastric cancer (GC). The designation follows a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA). HLX22, which is already designated as an orphan drug in the US, now stands to benefit from policy supports in the European Union, including protocol assistance for clinical studies, access to a centralized authorization procedure, and ten years of market exclusivity post-approval. The announcement emphasized that the company cannot guarantee successful development and commercialization of HLX22 and advised caution when dealing in the company's shares.