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Enlonesutamab (SG001) is a humanized IgG4 monoclonal antibody targeting the programmed cell death protein 1 (PD-1) receptor, developed by CSPC Megalith Biopharmaceutical. As an immune checkpoint inhibitor, it functions by blocking the interaction between PD-1 on T-cells and its ligands, PD-L1 and PD-L2, which are frequently exploited by tumor cells to suppress immune surveillance. By disrupting this inhibitory signaling pathway, enlonesutamab reactivates tumor-specific T-cells and enhances the body's anti-tumor immune response. It is currently being evaluated in various clinical trials for solid tumors, including recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), where it is being studied both as a monotherapy and in combination with other novel agents such as the Nectin-4-directed antibody-drug conjugate SYS6010.
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