China NMPA Approves TYVYT (sintilimab) – Big Molecule Watch

On June 24, 2022, Innovent Biologics, Inc. and Eli Lilly and Company announced that the National Medical Products Administration (NMPA) of China approved the supplemental New Drug Application (sNDA) for TYVYT (sintilimab)—a monoclonal antibody that targets and binds to PD-1 molecules resulting in the death of cancer cells—in combination with fluorouracil and platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. This marks the sixth NMPA-approved cancer indication for TYVYT, following its first approval in December 2018 for the treatment of relapsed or refractory classical Hodgkin’s lymphoma and subsequent approvals for nonsquamous and squamous non-small cell lung cancer (NSCLC), hepatocellular carcinoma, and esophageal squamous cell carcinoma.

According to the press release, Innovent has submitted an application seeking NMPA approval for sintilimab in combination with a bevacizumab biosimilar and chemotherapy for EGFR-mutated non-squamous NSCLC following EGFR-TKI treatment. The application is currently under review. Additionally, two clinical studies investigating sintilimab as a second-line treatment have met their primary endpoints—a phase II study in patients with esophageal squamous cell carcinoma and a phase III study in patients with squamous NSCLC with disease progression following platinum-based chemotherapy.