Solid tumors are emerging as the next frontier for CAR-T innovation, with China expected to introduce the world’s first approved CAR-T therapy for gastric cancer, according to GlobalData.

The anticipated approval is expected to expand CAR-T therapies beyond hematological malignancies and accelerate competition in the rapidly evolving solid tumor oncology market.

CARsgen Therapeutics’ satricabtagene autoleucel (satri-cel, CT041), a Claudin 18.2-targeting CAR-T therapy for advanced gastric and gastroesophageal cancers, is currently under review by China’s National Medical Products Administration (NMPA). The therapy is expected to become commercially available in China during the first half of 2026.

If approved, satri-cel would become the world’s first CAR-T therapy for solid tumors and China’s ninth CAR-T therapy overall.

According to the World Journal of Gastroenterology, China accounts for nearly 44% of global gastric cancer cases, highlighting the significant unmet need for advanced treatment options. While surgery, chemotherapy, and immunotherapy remain standard approaches, CAR-T therapy is now emerging as a promising new modality for solid tumors.

Abhishake Peyyeti, Pharma Analyst at GlobalData, states: “CARsgen is poised to become the first CAR-T company to gain approval beyond hematological malignancies. Through a strategic partnership with Jiahui Cancer Center, the Shanghai-based biopharma company aims to make Satri-cel therapy accessible following NMPA approval, offering new hope to patients with advanced gastric cancer.”

According to GlobalData Pharma Intelligence Center, 15 Chinese companies are currently developing CAR-T therapies for gastric cancer, with 22 drugs in clinical development across various stages in China. The pipeline includes one Phase III candidate, five Phase II therapies, 15 Phase I programs, and one pre-registration asset.