Anti-PD-1 (Sintilimab), Human IgG4 Antibody

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The research-grade biosimilar is a fully human IgG4 monoclonal antibody that targets the human cell surface receptor programmed cell death-1 (PD-1), an immune checkpoint protein with neoplastic functions. The antibody binds to PD-1 and prevents the association with its ligands PD-L1 and PD-L2. This results in inhibition of PD-1 and its downstream signaling, leading to the activation of T-cells and T-cell mediated immune response to inhibit tumor growth. The original drug is approved in China to treat relapsed or refractory patients with classic Hodgkin’s lymphoma, after the second-line of chemotherapy. Currently, this drug is in the process of FDA approval for use in the United States. The drug is undergoing clinical trials to test for safety and efficacy in the treatment of cancers such as non-small cell lung cancer and esophageal cancer