China’s NMPA approved Carsgen Therapeutics’ satricabtagene autoleucel (satri-cel, CT-041), marking the first global approval of a CAR T therapy for solid tumors. The Claudin18.2-targeted, autologous cell therapy received approval for patients with Claudin18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma after at least two prior lines. Carsgen positioned the approval as a class milestone because solid-tumor CAR T has historically struggled to reach approval endpoints. Company-reported trial outcomes showed a median progression-free survival of 3.25 months versus 1.77 months in a physician’s choice arm, alongside overall survival improvements. The approval is paired with a preconditioning regimen combining low-dose nab-paclitaxel with lymphodepletion chemotherapy. The regulatory decision also highlights how target selection and patient selection are becoming decisive differentiators in cellular therapy for solid tumors. For the CAR T field, the approval expands the commercialization pathway for solid-tumor cell therapies, potentially reshaping how sponsors design next programs around feasibility, safety, and efficacy measures.