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CARsgen's Satri-cel Granted Priority Review by the NMPA
CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces 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)(an autologous CAR T-cell product candidate against protein Claudin18.2), for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in
About this update from Carsgen Therapeutics Holdings Ltd.
[{"type":"text","content":"SHANGHAI, May 28, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces 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)(an autologous CAR T-cell product candidate against protein Claudin18.2), 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.","length":614,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/科济药业)","displaySize":"","headline":null,"caption":"(PRNewsfoto/科济药业)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":400,"url":"https://media.zenfs.com/en/prnewswire.com/5526ae7fcec6d3697a745ab2d0333d4b"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/pxBnvmJ9CDgFxmtruRHsdQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTcwNTtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/5526ae7fcec6d3697a745ab2d0333d4b","width":400,"height":400}},"href":"https://mma.prnewswire.com/media/1722549/Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"About Satri-cel","length":15,"tagName":"p"},{"type":"text","content":"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. Satri-cel targets the treatment of Claudin18.2-positive solid tumors with a primary focus on G/GEJA and pancreatic cancer (PC). Initiated trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced G/GEJA in China (CT041-ST-01, NCT04581473), a Phase Ib clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), an investigator-initiated trial for satri-cel be used as consolidation treatment following adjuvant therapy in patients with resected G/GEJA (CT041-CG4010, NCT06857786), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595). 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 ...