China NMPA accepts Juventas’ NDA for leukaemia treatment

The China National Medical Products Administration (NMPA) has accepted CASI Pharmaceuticals’ partner Juventas Cell Therapy’s new drug application (NDA) of CNCT19 (Inaticabtagene Autoleucel) to treat relapsed/refractory B-cell acute lymphoblastic leukaemia (r/r B-ALL) in adults.


This submission comprises preliminary findings from a Phase II open-label, single-arm, single-dose, multicentre clinical trial of CNCT19.


According to the findings, CNCT19 offered increased efficacy levels, lasting remissions and significantly lowered reduced CAR-T-associated toxicity in r/r B-ALL patients. 


CNCT19 attained exceptional objective response rates (ORRs) with increased MRD-negative complete remission rates in trial subjects within three months and by the end of the third month, respectively. 


In the trial, 82.1% of the subjects attained complete remission with incomplete count recovery (CR/Cri) within three months, and 25 subjects were reported to be CR/CRi by the end of the third month. 


Cytokine release syndrome and neurotoxicity were reported to be the most prevalent adverse events (AEs) linked to CNCT19.


CNCT19 is an investigational CAR-T cell therapy targeting CD-19.


In the registrational trial, the therapy showed a complete success rate of drug production in r/r B-ALL patients.


The CAR-T cell therapy received Orphan Drug Designation from the Food and Drug Administration (FDA) and a Breakthrough Designation from the China Center of Drug Evaluation (CDE).


CASI chairman and CEO Dr Wei-Wu He said: “CNCT19 NDA acceptance by NMPA represents a significant milestone. 


“We are in preparation for the anticipated CNCT-19 commercial launch. This product is truly exciting as it proved to have significant clinical benefits for unmet medical needs. 


“CASI and Juventas will work side-by-side to deliver CNCT19 to patients in China and eventually worldwide.”

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.


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