Shanghai Henlius Biotech Inc. has announced that the first patient in the United States has been dosed in an international multi-center Phase 3 clinical study of HLX22. This study, which combines HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) with Trastuzumab and Chemotherapy (XELOX), is being conducted to assess its efficacy for the first-line treatment of HER2-positive, locally advanced or metastatic gastroesophageal junction and gastric cancer. Additionally, the Phase 2 clinical trial application for HLX22 in combination with standard therapy for HER2-positive advanced gastric cancer has been approved in mainland China. As of this announcement, no marketing approval has been obtained for this combination therapy worldwide. The company advises shareholders and potential investors to exercise caution, as the successful development and commercialization of HLX22 cannot be guaranteed.
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