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HLX51 is a novel humanized agonistic anti-OX40 monoclonal antibody developed by Shanghai Henlius Biotech. It is designed to target and activate OX40 (tumor necrosis factor receptor superfamily member 4), an immune checkpoint molecule expressed on activated T cells. By competitively binding to OX40 and replacing its natural ligand OX40L, HLX51 activates the OX40 pathway without reducing downstream signaling. This activation promotes the proliferation of immune effector T cells and enhances their tumor-killing ability while inhibiting regulatory T cell (Treg) differentiation and function, thereby relieving immunosuppression in the tumor microenvironment. Preclinical studies have shown that HLX51 can inhibit tumor growth with good tolerance and safety profiles. The drug is being investigated for use in advanced/metastatic solid tumors, lymphomas, hepatocellular carcinoma, renal cell carcinoma (RCC), melanoma (including unresectable or metastatic forms), adjuvant treatment of melanoma, and microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer (mCRC)[1][2][3][4][5].
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