新开源参股公司永泰生物产品获CDE突破性疗法认定

Core Viewpoint - The China National Medical Products Administration (NMPA) has included the CAR-T-19 cell injection developed by Yongtai Biotech, a subsidiary of New Open Source, in its list of breakthrough therapies, targeting relapsed/refractory B-cell acute lymphoblastic leukemia in patients aged 25 and under [1] Group 1 - The CAR-T-19 cell injection is a chimeric antigen receptor T-cell therapy targeting CD19 [1] - The inclusion in the breakthrough therapy list signifies a potential acceleration in the development and approval process for this treatment [1] - The targeted patient population is specifically those aged 25 years and younger, indicating a focus on pediatric and young adult oncology [1]