On 30 July China's National Medical Products Administration (NMPA) approved local company Hrain Biotechnology's Hengkailai for relapsed/refractory large B-cell lymphoma, making it the fourth CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy cleared in China. The approval was based on Phase II trial data showing 74.1% objective response rate (ORR) and 49.4% complete response rate (CRR) in 81 patients, with median duration of response (mDOR) reaching 339 days.

Safety data indicated 95.1% cytokine release syndrome incidence (3.7% grade ≥3) and 8.6% immune effector cell-associated neurotoxicity syndrome (no grade ≥3 cases). Hrain's product joins three existing CD19 CAR-T therapies from Fosun Kairos, JW Therapeutics and Juventas in China's competitive lymphoma treatment market, among a total of seven approved CAR-T therapies in the country, according to PharmCube's NextBiopharm® database. Click here to request a free trial for NextBiopharm®.