NMPA Grants Breakthrough Status to CARsgen's Satri-cel Therapy

SHANGHAI, March 2, 2025 -- CARsgen Therapeutics Holdings Limited, under the stock code 2171.HK, has announced that its autologous CAR T-cell therapy, satricabtagene autoleucel ("satri-cel", CT041), has been awarded Breakthrough Therapy Designation by the Center for Drug Evaluation of China's National Medical Products Administration. This designation is for the treatment of Claudin18.2-positive advanced gastric and gastroesophageal junction cancer in patients who have not responded to at least two previous treatment lines.

CARsgen plans to submit a New Drug Application for satri-cel to Chinese authorities within the first six months of 2025. Dr. Zonghai Li, the founder, chairman, and chief executive officer of CARsgen, expressed enthusiasm about this regulatory milestone, highlighting how this designation could accelerate the approval process and make the therapy accessible to patients sooner.

Satri-cel is a pioneering autologous CAR T-cell product developed to target the protein Claudin18.2, which is prevalent in certain solid tumors. The therapy primarily focuses on treating gastric cancer and gastroesophageal junction cancer, with additional trials investigating its potential in pancreatic cancer treatment. Current research includes investigator-initiated trials and several clinical trials across different phases both within China and North America. In addition to its recent recognition in China, satri-cel has been honored with the Regenerative Medicine Advanced Therapy designation from the U.S. FDA for the treatment of advanced gastric and gastroesophageal junction cancers since January 2022, and received Orphan Drug status in the U.S. in 2020.

CARsgen Therapeutics is a biopharmaceutical entity operating in China and the United States, dedicated to developing innovative CAR T-cell therapies for both hematologic malignancies and solid tumors. The company has built a robust research and development infrastructure that spans from target discovery and innovative product development to clinical trials and production at a commercial scale. CARsgen's unique technologies and product pipeline, which include global rights, aim to tackle major challenges inherent in existing CAR T-cell therapies. These challenges include improving safety, enhancing efficacy for solid tumors, and reducing treatment costs. CARsgen's overarching mission is to emerge as a global leader in biopharmaceuticals, offering innovative cell therapies and striving to make cancer a curable disease for patients around the globe.