CARsgen Therapeutics Holdings Limited (HK2171), a China-based company involved in developing innovative CAR T-cell therapies, announced on Wednesday that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Priority Review to satricabtagene autoleucel (satri-cel, CT041) for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy.

Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. It targets the treatment of Claudin18.2-positive solid tumours with a primary focus on G/GEJA and pancreatic cancer (PC). Studies include investigator-initiated trials, a confirmatory Phase II clinical trial for advanced G/GEJA in China, a Phase Ib clinical trial for PC adjuvant therapy in China, an investigator-initiated trial for satri-cel be used as consolidation treatment following adjuvant therapy in patients with resected G/GEJA, and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America.

Satri-cel has been granted Breakthrough Therapy Designation by the CDE of China's NMPA for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in March 2025. Satri-cel was granted Regenerative Medicine Advanced Therapy designation by US FDA for the treatment of advanced G/GEJA with Claudin18.2-positive tumours in January 2022, and in September 2020 Satri-cel received Orphan Drug designation from the FDA for the treatment of G/GEJA.