China's Pioneering CAR-T Therapy for Solid Tumors Seeks Domestic Market Approval
2 week ago / Read about 0 minute
Author:小编   

Chi-Med Pharmaceuticals has announced that the National Medical Products Administration (NMPA) has formally accepted its application for marketing approval of Suriqiolunsai Injection, a groundbreaking CAR-T therapy. This innovative treatment is specifically designed for patients with advanced gastric or gastroesophageal junction adenocarcinoma that expresses Claudin18.2 and has not responded to at least two lines of prior therapy. As the world's first CAR-T cell therapy product for solid tumors to file for market approval, Suriqiolunsai Injection has previously garnered numerous breakthrough therapy designations and priority review qualifications. The application is supported by the outcomes of a Phase II clinical trial, which demonstrated superior progression-free survival and overall survival rates compared to standard treatments, while maintaining a manageable safety profile. Currently, while China has approved six CAR-T therapies, all of them are indicated for the treatment of hematological malignancies. The development of CAR-T therapies for solid tumors presents significant challenges, primarily due to the complexities of the tumor microenvironment and the high antigen heterogeneity present in these types of cancers.