China’s NMPA approved Carsgen Therapeutics’ satricabtagene autoleucel (satri-cel, CT-041), positioned as the first global CAR-T approval for solid tumors. The Claudin18.2-targeted, autologous therapy is approved for Claudin18.2-positive, HER2-negative advanced gastric and gastroesophageal junction adenocarcinoma after at least two prior lines of therapy. The approval supports a class-defining narrative for CAR-T in solid tumors, which have historically faced major clinical barriers. Carsgen highlighted its preconditioning regimen and previously reported efficacy metrics as part of the submission rationale.