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Juventas Cell Therapy’s CAR-T Therapy Clears for SLE-ITP Study in China
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The China Center for Drug Evaluation (CDE) has given the green light for a study on inaticabtagene autoleucel (CNCT 19), a chimeric antigen receptor (CAR)-T cell therapy developed by Juventas Cell Therapy Ltd, a Chinese firm. This therapy is now approved for research in refractory systemic lupus erythematosus-associated immune thrombocytopenia…
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China’s NMPA Grants Conditional Approval for Juventas’ CAR-T Therapy Inaticabtagene Autoleucel
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The National Medical Products Administration (NMPA) has conditionally approved the marketing of inaticabtagene autoleucel (CNCT 19), a chimeric antigen receptor (CAR)-T cell therapy developed by Chinese firm Juventas Cell Therapy Ltd. The drug is indicated for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in China. Inaticabtagene Autoleucel’s…
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Juventas Cell Therapy’s CNCT19 Receives FDA IND Approval for r/r B-ALL Treatment
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China-based Juventas Cell Therapy Ltd’s chimeric antigen receptor (CAR) T-cell therapy, CNCT19 (Inaticabtagene Autoleucel), has obtained Investigational New Drug (IND) approval from the US FDA for the treatment of recurrent or refractory B-cell acute lymphocytic leukemia (r/r B-ALL). Previous Approvals and StatusCNCT19, a CD19-targeted CAR-T therapy, has previously earned IND…
