China’s National Medical Products Administration (NMPA) has approved CT041 (satri-cel) from CARsgen Therapeutics. The drug is indicated for patients with advanced gastric or gastroesophageal junction adenocarcinoma that is CLDN18.2-positive and HER2-negative, who have failed at least two prior lines of therapy. The company claims the therapy is the world’s first CAR-T cell treatment for solid tumours to receive regulatory approval.
The registration application was submitted to China’s Center for Drug Evaluation (CDE) as early as June 2025. Shanghai regulators promised to expedite the process by providing priority support during reviews and inspections. The Chinese regulator’s decision marks a significant milestone in the development of cell-based immunotherapy.
CT041 targets the CLDN18.2 protein, which is found in 80% of patients with gastric and pancreatic cancers. In trials, the drug demonstrated high efficacy: tumours shrank in 55% of patients, and overall survival doubled compared with standard therapy. The company called the regulator’s decision a “turning point” for patients with no other treatment options.
The approval is based on results from the CT041-ST-01 trial led by Professor Shen Lin of Peking University Cancer Hospital. The risk of progression fell by 70%, and median overall survival increased by nearly six months.
CAR-T therapy is a form of immunotherapy in which a patient’s immune cells are modified to recognise and destroy cancer cells. Until now, such approaches have been used mainly for haematological malignancies. The approval of a drug for gastric cancer opens a new frontier in oncology. According to Research and Markets, the global cell and gene therapy market is expected to reach $26.2 billion in 2026 and grow to $60.6 billion by 2030, representing a compound annual growth rate of 23.3%.
As Reuters reported earlier, scientists achieved long-term control of HIV infection for the first time using a single infusion of modified immune cells in a small human clinical trial. According to the agency, CAR-T therapy – already proven effective against some blood cancers – could become the basis for a “functional cure” for HIV.