国家药监局批准我国原研首款双适应症CAR-T

Group 1 - The National Medical Products Administration has approved the CAR-T cell therapy product, Nakiolunase injection, for the treatment of relapsed or refractory large B-cell lymphoma after second-line or higher systemic therapy, making it the only CAR-T product in China that covers both leukemia and lymphoma indications [1] - Lymphoma is one of the most common malignant hematological tumors, with large B-cell lymphoma being the most prevalent type of adult non-Hodgkin lymphoma. Approximately 40% of patients experience progression or relapse after first-line treatment, indicating a poor prognosis and significant clinical challenges [1] - Nakiolunase injection is China's first CD19 CAR-T cell therapy product with full independent intellectual property rights, developed from the long-term technological innovations of the Chinese Academy of Medical Sciences Hematology Hospital, featuring a unique global CD19scFv (HI19a) structure and internationally leading production processes [1] Group 2 - In November 2023, Nakiolunase injection was approved for the treatment of adult relapsed or refractory B-cell acute lymphoblastic leukemia, based on results from a pivotal phase II clinical study that evaluated its use in treating refractory large B-cell lymphoma [2] - The key clinical study was led by the Chinese Academy of Medical Sciences Hematology Hospital and Ruijin Hospital affiliated with Shanghai Jiao Tong University, conducted across more than ten clinical centers nationwide [2] - Clinical research data indicate that Nakiolunase injection provides durable remission and long-term survival benefits for lymphoma patients, demonstrating safety and offering a potential cure for patients facing significant treatment challenges [2]