Inaticabtagene Autoleucel (CNCT19 Injection) is the first core product candidate of Juventas Cell Therapy, it is also the first CD19-directde CAR-T product with Chinese independent intellectual property rights. CD19 scFv (HI19a) structure and CMC technique. It has obtained three IND approval from the NMPA, for the treatment of adult relapsed and refractory acute lymphoblastic leukemia, relapsed and refractory aggressive B-cell non-Hodgkin lymphoma, and pediatric and adolescent B-cell acute lymphoblastic leukemia. It was granted Breakthrough Therapy Designation by Center for Drug Evaluation, National Medical Products Administration (CDE, NMPA) and Orphan Drug Designation (ODD) by the U.S. FDA. Nov 2023, China’s National Medical Product Administration (NMPA) has formally approved its New Drug Application (NDA) for Inaticabtagene Autoleucel (CNCT19 Injection), for the treatment of adult relapsed and refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).

• 2023-11-07
  Juventas Cell Therapy Announces Approval of Its New Drug Application (NDA) for Inaticabtagene Autoleucel in China
• 2023-03-09
  Juventas Announces FDA Clearance of the IND Application for Clinical Trial of Inaticabtagene Autoleucel
• 2022-12-22
  Juventas’ Inaticabtagene Autoleucel (CNCT19 Injection) Granted Priority Review by CDE, NMPA

Clinical development abilities and scalable pipeline layout demonstrate the vitality of an excellent biomedical company. Juventas develops by technological innovation covering blood and solid tumors to meet clinical demands and accelerate industrialization.