The Center for Drug Evaluation (CDE) website indicates that Hrain Biotechnology Co., Ltd’s BCMA – targeted chimeric antigen receptor (CAR) T cell therapy and Novartis’ Zolgensma (OAV101) have been awarded breakthrough therapy designations (BTDs). Hrain Bio’s BCMA CAR – T cell is indicated for relapsed / refractory multiple myeloma. The drug previously obtained tacit clinical trial approval from the National Medical Products Administration (NMPA) in December 2018. The study for the drug in this indication showed that, in 20 enrolled subjects, the overall objective response rate was 85%.
Novartis’s Zolgensma
Novartis’s OAV101 is indicated for spinal muscular atrophy (SMA). A global Phase III STEER study in 2 – 18 – year – old patients with type 2 spinal muscular atrophy was initiated in China in April, expected to enroll 20 and 125 subjects in China and the US respectively. The drug, approved in the US in May 2019 to treat type I SMA patients under two years of age, is undergoing clinical study in elderly patients.-Fineline Info & Tech
