Precision Biotech has received a conditional approval from China's National Medical Products Administration (NMPA) for CD19 CAR-T therapy pCAR-19B in patients aged 3 to 21 years with relapsed or refractory CD19-positive acute lymphoblastic leukaemia (ALL) following a priority review. The autologous cell therapy features an optimised chimeric antigen receptor structure and enhanced safety profile through an improved gene transduction vector system, demonstrating 100% complete response rate (CRR) in a Phase I trial involving nine paediatric patients, with minimal residual disease (MRD) negativity achieved in all responders. No dose-limiting toxicities or treatment-related mortality events were reported, with a favourable overall safety and tolerability profile supporting commercial launch.

The approval represents the fifth CD19 CAR-T therapy available in China following earlier approvals for axicabtagene ciloleucel from Fosun Kairos, relmacabtagene autoleucel from JW Therapeutics, inaticabtagene autoleucel from Juventas and HR001 from Hrain Biotechnology. Precision Bio's candidate addresses a significant unmet need in paediatric oncology where relapsed ALL carries poor prognosis with limited treatment options following chemotherapy and immunotherapy failure.

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