China’s National Medical Products Administration approved Carsgen’s satricabtagene autoleucel (satri-cel, CT-041), positioning it as the first CAR-T therapy globally approved for solid tumors. The autologous, Claudin18.2-targeted therapy is indicated for patients with Claudin18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma after at least two prior lines. Carsgen said the approval follows phase 2 data where the therapy demonstrated progression-free survival benefits versus physician’s choice treatment and included a preconditioning regimen combining low-dose nab-paclitaxel with lymphodepletion chemotherapy. The decision highlights how solid-tumor CAR-T is moving into a more regulated, label-driven adoption pathway in China.