China Approves World's First CAR-T Therapy for Solid Tumors, Targeting Gastric Cancer

China's National Medical Products Administration (NMPA) has approved a gastric cancer treatment developed by CARsgen Therapeutics, marking the world's first approval of a chimeric antigen receptor T-cell (CAR-T) therapy for solid tumors. The therapy, marketed as Kailimei and scientifically known as satricabtagene autoleucel (satri-cel), is an autologous CAR-T product designed to target Claudin18.2 (CLDN18.2)-expressing tumors. It is cleared for patients with advanced, CLDN18.2-positive and HER2-negative gastric cancer or gastroesophageal junction adenocarcinoma who have failed at least two prior lines of treatment. CARsgen priced the therapy at 990,000 yuan ($146,491) per infusion during a Tuesday investor call. The approval represents a significant milestone for the CAR-T industry, as no CAR-T therapy for solid tumors has previously received marketing authorization anywhere in the world. Over the past decade, CAR-T therapies have primarily been used to treat hematological malignancies, while their effectiveness against solid tumors has remained under evaluation. Industry participants estimate that successful commercialization in solid tumors could expand the addressable market for CAR-T therapies by nearly 10 times. The approval process was supported by Shanghai regulators, who pledged to accelerate the review. The Shanghai Municipal Drug Administration, led by Deputy Director Guo Shuting, said it had strengthened pre-approval support services and prioritized good manufacturing practice (GMP) compliance inspections for innovative products under the principle of "early intervention and full-process guidance." Industry leaders have expressed optimism about the broader implications of this approval. An executive at another CAR-T developer called it "positive for the entire industry" and predicted it could accelerate the clinical application of CAR-T therapies across a broader range of cancers. Yu Xuejun, founder and chairman of immunotherapy company Huadao Biotech, noted that CAR-T cells can actively target tumor cells that express specific antigens on their surface, describing the approach as a "broad-spectrum anti-cancer therapy" that may provide long-term benefits after a single administration. Hungary at this moment steps up:

The global cell and gene therapy market is expected to reach $26.2 billion in 2026, according to Research and Markets, underscoring the growing interest in advanced therapies. CARsgen's approval in China may pave the way for similar therapies to treat other solid tumors, potentially transforming cancer care.