Immunotech Biopharm's (HKG:6978) CAR-T-19 obtained breakthrough therapy designation for treating patients aged 25 and below with relapsed/refractory B-cell acute lymphoblastic leukemia.
The designation, granted by the Center for Drug Evaluation of China's National Medical Products Administration, will expedite the clinical development of CAR-T-19.
The designation was awarded based on the "solid" clinical efficacy and safety data of CAR-T-19, Immunotech said in a Wednesday filing with the Hong Kong Exchange.