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Casi and Juventas Cell Therapy's CNCT19 (CD19 CAR-T) Receives China NMPA's BT Designation for Relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL)

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Casi and Juventas Cell Therapy's CNCT19 (CD19 CAR-T) Receives China NMPA's BT Designation for Relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL)

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  • The BT (breakthrough therapy) Designation was based on initial data for ongoing single-arm- open-label- non-randomized- dose-escalation- P-I study for safety and efficacy in B-ALL
  • The BT Designation procedure is under NMPA's revised Drug Registration Regulation with effect from Jul 1- 2020. It is designed to expedite the development of treatment of diseases with no existing treatment and evidence indicates the benefit of the therapy vs available treatment
  • CNCT19 targets CD19 is a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CNCT19 is currently being developed by Casi and Juventas Cell Therapy

 ­ Ref: Casi Pharmaceuticals  | Image: Casi Pharmaceuticals

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