Solid tumors are emerging as the next frontier for CAR-T innovation, with China poised to deliver the world’s first approved CAR-T therapy for gastric cancer. The anticipated approval signals a pivotal shift in oncology treatment, expanding CAR-T beyond hematological malignancies and intensifying competition in the rapidly evolving solid tumor landscape, where early clinical success, regulatory momentum, and market access strategies will define long-term leadership, according to GlobalData,, a leading intelligence and productivity platform.

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

Following NMPA approval, this development marks a significant milestone as the world’s first CAR-T therapy for solid tumors and China’s ninth CAR-T therapy.

According to the World Journal of Gastroenterology, gastric cancer poses a major health challenge in China, accounting for 44% of global cases. Beyond traditional surgical resection and chemotherapy, the current therapeutic landscape includes immunotherapy.

However, the emergence of CAR-T therapy introduces a new treatment option for solid tumors.  Satri-cel is China’s first autologous CAR-T cell product for gastric and gastroesophageal cancers. Phase II trial results demonstrated an objective response rate (ORR) of 41%, with progression-free survival extended to approximately 4.7 months.

Satri-cel received priority review from NMPA in May 2025 for third-line treatment of gastric and gastroesophageal cancers. Additionally, it is being investigated as an adjuvant therapy for gastric and pancreatic cancers in a Phase I study. CARsgen is also expanding its presence in the North American CAR-T market with ongoing Phase II/III studies for gastric and pancreatic cancers in the US and Canada.

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 the GlobalData Pharma Intelligence Center, 15 Chinese companies are involved in the clinical development of CAR-T therapies for gastric cancer, with 22 drugs currently in clinical development in China. There is one drug in Phase III, five drugs in Phase II, 15 drugs in Phase I, and one drug in pre-registration.

Suzhou Immunofoco Biotechnology’s IMC-002 is emerging as a strong competitor in the gastric cancer market. Currently in Phase III trials as a third-line CAR-T therapy, the company is already looking to expand into earlier-line treatment settings.

Peyyeti concludes: “With Satri-cel expected to receive NMPA approval, CARsgen is positioned to lead China’s CAR-T landscape in solid tumors, cementing its first-mover advantage through aggressive adjuvant and first-line clinical trials while staying ahead of emerging Phase III competitors like Suzhou Immunofoco.”