China's National Medical Products Administration approved CARsgen Therapeutics Holdings Limited's Satri-cel (satricabtagene autoleucel) on June 22, making it the world's first CAR-T therapy approved for the treatment of solid tumors and offering a new option for patients with advanced gastric cancer.

CARsgen Pharmaceuticals. [Photo/WeChat ID: pdnews]

The NMPA granted approval through its priority review pathway to Kaixing Life Technology (Shanghai) Co Ltd, a subsidiary of CARsgen Therapeutics Holdings Limited, marking a significant regulatory milestone for cell and gene therapy in China.

Satri-cel is indicated for patients with CLDN18.2-positive, HER2-negative unresectable advanced gastric or gastroesophageal junction adenocarcinoma whose disease has progressed after at least two prior lines of treatment. The approval provides a breakthrough cellular therapy option for patients.

The therapy is the first CAR-T treatment in the world approved for a solid tumor, addressing a major unmet medical need. Most existing CAR-T therapies are used to treat blood cancers such as leukemia and lymphoma.

Clinical investigator-initiated studies published in Nature Medicine and presented at the European Society for Medical Oncology meeting demonstrated promising efficacy in gastric and pancreatic cancers, including high objective response rates and significant declines in disease biomarkers.

CARsgen has established an integrated CAR-T manufacturing system encompassing plasmid production, lentiviral vector production, and cell manufacturing. The platform enables end-to-end control of the production process, from upstream materials to final product supply and clinical application in China.

Pudong has developed one of China's leading cell and gene therapy clusters, home to more than 180 companies, and five approved CAR-T products, accounting for 25 percent of the global total. The ecosystem is supported by strong multinational participation and a robust clinical research network.