Key facts
- China approved the world's first CAR-T cell therapy for solid tumors in June.
- A New Zealander was the first international patient to receive this solid tumor CAR-T therapy.
- China approved three new CAR-T products between March 2025 and March 2026.
- China is a leader in clinical trials for solid tumor CAR-T therapies.
- CAR-T cell therapy involves collecting a patient's T cells, modifying them to target cancer cells, and reintroducing them.
China is emerging as a leader in CAR-T cell therapy, particularly for solid tumors, a frontier that has long challenged the treatment's efficacy. In June, Chinese regulators approved the world's first CAR-T therapy specifically for solid tumors, a significant advancement beyond its established use in blood cancers. This breakthrough treatment was administered to a New Zealander with advanced stomach and intestinal cancer in July, marking the first time an international patient received this therapy for a solid tumor.
China's National Medical Products Administration (NMPA) has been accelerating its approval process for CAR-T therapies. Between March 2025 and March 2026, three new CAR-T products were approved, a pace comparable to or exceeding the US Food and Drug Administration (FDA) in the same period. Notable approvals include a CD22-targeting CAR-T for specific B-cell relapse scenarios in late 2025, a dual-antigen targeting CAR-T for multiple myeloma in early 2026, and a GD2-targeting CAR-T for pediatric neuroblastoma. In June 2026, a specific CAR-T therapy for CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal-junction adenocarcinoma was also approved.
The extension of CAR-T therapy to solid tumors, which constitute 90% of cancer deaths, has been a major goal in oncology. China is at the forefront of this effort, leading in clinical trials for solid tumor CAR-T. Promising results have emerged from trials targeting mesothelin for pleural mesothelioma and lung cancer, with a 35% objective response rate reported in a Phase II trial. Trials for HER2-targeting CAR-T in gastric and breast cancer are also ongoing, with one Phase II trial showing a 28% objective response rate in HER2-positive gastric cancer patients. Furthermore, China is leading global trial activity for Claudin18.2-targeting CAR-T in gastric and pancreatic cancers.
For international patients, China's active clinical trial landscape offers a potential access pathway to novel CAR-T therapies for solid tumors, for which no commercial products are yet available globally. However, eligibility for these trials is strict and depends on specific disease characteristics, biomarkers, prior treatments, and overall health status. CAR-T cell therapy itself is a personalized treatment where a patient's T cells are modified to recognize and attack cancer cells, typically involving chemotherapy preparation and close post-infusion monitoring. Major risks include cytokine release syndrome, neurological toxicity, and infection.