China’s National Medical Products Administration (NMPA) approved Carsgen Therapeutics’ satricabtagene autoleucel (satri-cel, CT-041), marking the first global approval of a CAR T therapy for solid tumors. The autologous Claudin18.2-targeted therapy is for patients with Claudin18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma who have failed at least two prior lines of therapy. Carsgen’s approval follows a phase 2 study reported as meeting its primary progression-free survival endpoint versus physician’s choice chemotherapies. Company-reported efficacy included a median progression-free survival of 3.25 months versus 1.77 months, alongside median overall survival of 7.92 months versus 5.49 months. The approval also adds to the growing case that solid-tumor CAR T can move beyond clinical experimentation toward registrational pathways—though execution details such as eligibility, manufacturing logistics, and safety remain central issues for payer and provider adoption.