Comprehensive Report on Sintilimab (TYVYT®): A PD-1 Inhibitor

Executive Summary

Sintilimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody that functions as an immune checkpoint inhibitor by targeting the programmed cell death protein 1 (PD-1) receptor. Developed through a strategic collaboration between China-based Innovent Biologics and the global pharmaceutical firm Eli Lilly and Company, Sintilimab is engineered for high-affinity binding and sustained receptor occupancy. Its mechanism of action involves blocking the interaction between PD-1 on T-cells and its ligands (PD-L1 and PD-L2), thereby restoring the host's anti-tumor immune response.

Marketed in China as TYVYT®, Sintilimab has achieved significant clinical and commercial success, securing numerous approvals from the National Medical Products Administration (NMPA) for a wide range of high-incidence malignancies. These include classical Hodgkin's lymphoma, non-small cell lung cancer (both squamous and non-squamous subtypes), hepatocellular carcinoma, esophageal squamous cell carcinoma, gastric cancer, and endometrial cancer. Its inclusion in China's National Reimbursement Drug List (NRDL) for most of these indications has cemented its position as a cornerstone of immuno-oncology therapy in the country.