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Inaticabtagene autoleucel - Juventas Cell Therapy/CASI Pharmaceuticals

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Drug Profile

Inaticabtagene autoleucel - Juventas Cell Therapy/CASI Pharmaceuticals

Alternative Names: Anti-CD19 CAR-T cell therapy - Juventas Cell Therapy; CNCT-19; CNTC-19; HI19α-4-1BB-ζ CAR; HY 001; HY-001-Juventas Cell Therapy; HY-001N; Ina-cel; YORWIDATM

Latest Information Update: 22 Dec 2025

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At a glance

  • Originator Chinese Academy of Medical Sciences
  • Developer CASI Pharmaceuticals; Juventas Cell Therapy
  • Class Antineoplastics; CAR-T cell therapies; Gene therapies; Immunotherapies
  • Mechanism of Action Immunologic cytotoxicity; T lymphocyte replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Precursor B-cell lymphoblastic leukaemia-lymphoma
  • New Molecular Entity No

Highest Development Phases

  • Marketed Precursor B-cell lymphoblastic leukaemia-lymphoma
  • Registered Non-Hodgkin's lymphoma
  • Phase I/II Diffuse large B cell lymphoma
  • Phase I Acute biphenotypic leukaemia; Autoimmune haemolytic anaemia; Idiopathic thrombocytopenic purpura
  • Preclinical Systemic lupus erythematosus
  • No development reported B-cell lymphoma

Most Recent Events

  • 22 Dec 2025 Launched for Precursor B-cell lymphoblastic leukaemia-lymphoma (Second-line therapy or greater, In adults) in China (IV)
  • 22 Dec 2025 Preclinical trials in Systemic lupus erythematosus in China (IV) (Juventas Cell Therapy pipeline, December 2025)
  • 22 Dec 2025 Juventas Cell Therapy plans to submit BLA application for Acute biphenotypic leukaemia (In children, In infants, In neonates) (Juventas Cell Therapy pipeline, December 2025)

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