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Puputelimab (HX008) is a humanized IgG4 monoclonal antibody targeting the programmed cell death protein 1 (PD-1) receptor. Developed by Lepu Biopharma, it functions as a checkpoint inhibitor by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade prevents the inhibitory signaling that typically suppresses T-cell activation, thereby restoring and enhancing the immune system's ability to identify and destroy tumor cells. In China, puputelimab has received conditional marketing approval from the NMPA for the treatment of patients with unresectable or metastatic melanoma who have failed previous systemic therapy, as well as for patients with advanced solid tumors that are microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) who have progressed after standard treatments.
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