Kaili Pharma Submits NDA for Satri-cel (CT041), the World’s First CAR-T Therapy for Solid Tumors

On June 25, 2025, CARsgen Therapeutics announced that the New Drug Application (NDA) for surzebicabtagene autoleucel injection (product code: CT041, an autologous CAR-T cell product targeting Claudin 18.2) had been formally submitted to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). The application is for the treatment of patients with advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) who are Claudin 18.2-positive and have failed at least two prior lines of therapy.

According to reports, Shu Rui Ji Ao Lun Sai Injection is the world’s first and only CAR-T cell product submitted for New Drug Application (NDA) for the treatment of solid tumors.

This NDA submission is based on the results of a confirmatory Phase II clinical trial (CT041-ST-01, NCT04581473), which was an open-label, multicenter, randomized controlled study conducted in China. The clinical trial results have been officially published in The Lancet and presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

The study results demonstrated that, in patients with Claudin18.2-positive gastric/gastroesophageal junction adenocarcinoma who had failed at least two prior lines of therapy, surucabtagene autoleucel significantly improved progression-free survival (PFS) compared with standard of care, showed a clinically meaningful benefit in overall survival (OS), and exhibited a manageable safety profile.

Previously, the CDE had granted Breakthrough Therapy Drug designation to shuairuijioluncai injection in March 2025, and included it in the Priority Review pathway in May 2025.