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Dulpatatug (HLX22, AC-101) is a humanized monoclonal IgG1 antibody developed by Shanghai Henlius Biotech, originally licensed from AbClon. It targets a novel epitope on the human epidermal growth factor receptor 2 (HER2), which is distinct from the binding domains of established anti-HER2 therapies like trastuzumab and pertuzumab. This unique binding profile allows dulpatatug to potentially act synergistically with other HER2-targeted agents. The drug's mechanism of action involves the inhibition of HER2-mediated signaling pathways and the induction of antibody-dependent cellular cytotoxicity (ADCC) to eliminate tumor cells. Dulpatatug is currently in Phase 3 clinical development for the first-line treatment of HER2-positive gastric and gastroesophageal junction cancers in combination with trastuzumab and chemotherapy, and is also being investigated for HER2-positive breast cancer.
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