China-based chimeric antigen receptor T-cell (CAR-T) specialist Immunotech Biopharm Ltd (HKG: 6978) has announced receiving Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its CAR-T-19 injection. This designation is awarded for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) patients aged 25 and under, marking a significant milestone in the advancement of CAR-T therapies in China.
CAR-T-19 Injection: A Second-Generation CD19 Targeted CAR-T Therapy
CAR-T-19 injection is a second-generation CD19 targeted CAR-T therapy that has been widely recognized for its safety and efficacy. First approved for clinical trials in China in 2020, the drug’s study has demonstrated a smooth progression, with data as of December 2024 showing good overall safety and controllable risks. This positive profile positions CAR-T-19 as a promising candidate for treating B-ALL patients in the specified age group.
Potential Impact on B-ALL Treatment in China
There is currently no CAR-T therapy approved in China for the treatment of relapsed/refractory B-ALL, although there is one such product registered outside of China. The NMPA’s Breakthrough Therapy Designation for ImmunoTech Biopharm’s CAR-T-19 injection highlights the potential of this therapy to fill an unmet medical need and improve treatment outcomes for young patients suffering from B-ALL.-Fineline Info & Tech
