The National Medical Products Administration (NMPA) website indicates that China-based Innovent Biologics, Inc. (HKG: 1801) has received approval for a new indication of its PD-1 inhibitor Tyvyt (sintilimab) for the treatment of first-line esophageal squamous cell carcinoma (ESCC). This marks the fifth indication approval for the drug in China.
Drug Mechanism and Development
Sintilimab, jointly developed by Innovent and US major Eli Lilly & Co. (NYSE: LLY), is an immunoglobulin G4 monoclonal antibody that binds to PD-1 molecules on T-cells, blocking the PD-1/PD-L1 pathway and reactivating T-cells to kill cancer cells. Innovent is currently conducting over 20 clinical studies with Tyvyt to evaluate its safety and efficacy across various cancer indications, including more than 10 registrational or pivotal-stage trials.
Approved Indications
In China, Tyvyt has been approved for four indications:
- Third-line treatment for relapsed or refractory classic Hodgkin’s lymphoma (cHL).
- Combined with pemetrexed and platinum chemotherapy as a first-line treatment for nonsquamous non-small cell lung cancer (NSCLC).
- Combined with gemcitabine and platinum chemotherapy for the first-line treatment of squamous NSCLC.
- Combined with Byvasda (bevacizumab biosimilar injection) for the first-line treatment of hepatocellular carcinoma.
Regulatory Submissions
Innovent currently has two regulatory submissions under review by China’s NMPA for sintilimab, for the first-line treatment of gastric cancer and the first-line treatment of unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma combined with chemotherapy (oxaliplatin + capecitabine).
Market Recognition
Tyvyt was the first PD-1 inhibitor to be included in China’s National Reimbursement Drug List (NRDL) in 2019.-Fineline Info & Tech
