CARsgen's Satri-cel Granted Priority Review by the NMPA

Company Overview - CARsgen Therapeutics Holdings Limited is focused on developing innovative CAR T-cell therapies to address unmet clinical needs in hematologic malignancies, solid tumors, and autoimmune diseases [3] - The company has established end-to-end capabilities for CAR T-cell research and development, including target discovery, preclinical research, clinical development, and commercial-scale production [3] - CARsgen aims to improve the safety profile, enhance efficacy in treating solid tumors, and reduce treatment costs of CAR T-cell therapies [3] Product Development - Satri-cel is an autologous CAR T-cell product candidate targeting Claudin18.2, with a primary focus on treating Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) and pancreatic cancer [2] - The product has received Priority Review from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for patients who have failed at least two prior lines of therapy [1] - Satri-cel has been granted Breakthrough Therapy Designation by the CDE in March 2025 and has received Orphan Drug designation from the U.S. FDA in September 2020 [2] Clinical Trials - Ongoing clinical trials for Satri-cel include a confirmatory Phase II trial for advanced G/GEJA in China, a Phase Ib trial for pancreatic cancer adjuvant therapy, and a Phase 1b/2 trial for advanced gastric or pancreatic adenocarcinoma in North America [2] - The company is also conducting investigator-initiated trials to explore the use of Satri-cel as a consolidation treatment following adjuvant therapy in patients with resected G/GEJA [2]