CARsgen's Claudin18.2 CAR-T Therapy Satri-cel Granted Breakthrough Therapy Designation by the NMPA

Core Insights - CARsgen Therapeutics Holdings Limited has received Breakthrough Therapy Designation for its CAR T-cell therapy, satricabtagene autoleucel ("satri-cel"), targeting Claudin18.2-positive advanced gastric/gastroesophageal junction cancer [1][3] - The company plans to submit a New Drug Application (NDA) for satri-cel to the National Medical Products Administration (NMPA) in the first half of 2025 [2] - Satri-cel is positioned to be a first-in-class therapy, with ongoing clinical trials in both China and North America [4] Company Overview - CARsgen is a biopharmaceutical company focused on innovative CAR T-cell therapies for hematologic malignancies and solid tumors, with operations in China and the U.S. [5] - The company has developed a comprehensive CAR T-cell research and development platform, addressing challenges in safety, efficacy, and cost of existing therapies [5] - CARsgen aims to become a global leader in biopharmaceuticals, providing innovative cell therapies for cancer patients worldwide [5]