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CARsgen's satri-cel application accepted for gastric cancer treatment in China

June 26, 2025 at 05:05 PM UTCBy FilingReader AI

CARsgen Therapeutics Holdings Limited announced that the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for satricabtagene autoleucel ("satri-cel", CT041) for treating Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. The NDA submission relies primarily on results from a Phase II clinical trial (CT041-ST-01, NCT04581473). Satri-cel previously received Priority Review and Breakthrough Therapy Designation from the CDE of China's NMPA for the same indication, in May and March of 2025 respectively, plus Regenerative Medicine Advanced Therapy designation from U.S. FDA in January 2022. In addition to the gastric cancer application, CARsgen is expanding satri-cel's application, including for pancreatic cancer and consolidation treatment following adjuvant therapy in patients with resected G/GEJA.

This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com

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