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BioWorld - Friday, December 19, 2025
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Home » China’s NMPA accepts Carsgen’s NDA for Claudin18.2-targeted CAR T
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China’s NMPA accepts Carsgen’s NDA for Claudin18.2-targeted CAR T

June 27, 2025
By Tamra Sami
No Comments
China’s National Medical Products Administration (NMPA) has accepted for review Carsgen Therapeutics Holdings Ltd.’s NDA for satricabtagene autoleucel (satri-cel, CT-041), an autologous CAR T candidate targeting Claudin18.2 for treating Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. Just one day earlier, Carsgen announced that it had submitted the satri-cel NDA to the NMPA.
BioWorld Regulatory Cancer CAR T Asia-Pacific China U.S. NMPA

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