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CARsgen's Claudin18.2 CAR-T Therapy Satri-cel Granted Breakthrough Therapy Designation by the NMPA
CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to satricabtagene autoleucel ("satri-cel", CT041) for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction cancer (G/GEJ) in patient
About this update from Carsgen Therapeutics Holdings Ltd.
[{"type":"text","content":"SHANGHAI, March 2, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to satricabtagene autoleucel ("satri-cel", CT041) for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction cancer (G/GEJ) in patients who have failed at least two prior lines of therapy.","length":608,"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":"The company plans to submit a New Drug Application (NDA) for satri-cel to the NMPA in the first half of 2025.","length":109,"tagName":"p"},{"type":"text","content":""We are fully committed to advancing the preparation work for the NDA submission of satri-cel. We are delighted that satri-cel has received Breakthrough Therapy Designation, which is expected to expedite its approval process and bring this therapy to patients as soon as possible," said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics.","length":423,"tagName":"p"},{"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 gastric cancer/gastroesophageal junction cancer (GC/GEJ) and pancreatic cancer (PC). Ongoing trials include inves...