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IBI319 is a bispecific monoclonal antibody designed for cancer immunotherapy. It targets both programmed cell death protein 1 (PD-1) and tumor necrosis factor receptor superfamily member 9 (CD137 or 4-1BB), functioning as an immune checkpoint inhibitor and T-cell co-stimulatory agonist. By binding to PD-1, it blocks the inhibitory PD-1 pathway, while its conditional agonism of 4-1BB enhances T-cell activation specifically in the tumor microenvironment. This dual mechanism aims to boost anti-tumor immune responses while minimizing systemic toxicity commonly associated with CD137-targeting agents. Preclinical and early clinical studies have shown promising tumor suppression effects and good tolerability, with ongoing phase I trials in patients with advanced solid tumors or hematological malignancies[1][2][3][4][5][7].
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