Business
CARsgen Therapeutics Announces NDA Acceptance of Satri-cel by China's NMPA
CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for 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
About this update from Carsgen Therapeutics Holdings Ltd.
[{"type":"text","content":"SHANGHAI, June 25, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for 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. The NDA submission is mainly based on the results of an open-label, multicenter, randomized controlled confirmatory Phase II clinical trial (CT041-ST-01, NCT04581473) conducted in China. The data have been presented in The Lancet and at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.","length":900,"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":"In addition, the company is actively expanding satri-cel application in early-line treatment and perioperative treatment of cancer, including an ongoing Phase Ib registrational trial for pancreatic cancer adjuvant treatment and an ongoing investigator-initiated trial for consolidation treatment following adjuvant therapy in patients with resected G/GEJA.","length":356,"tagName":"p"},{"type":"text","content":"Professor Lin Shen from Beijing Cancer Hospital, the principal investigator of the CT041-ST-01 clinical trial, said, "Gastric cancer is a malignancy with a substantial global disease burden and significant treatment challenges. For patients with advanced gastric cancer, in particular, existing therapeutic options and their efficacy remain severely limited...