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    Yikaida CAR-T Cell Therapy Approved as a Second-line Therapy for New Indication

    Details:

    YIKAIDA (axicabtagene ciloleucel injection) is an autologous CD19-targeted CAR T-cell therapy that was authorized to be locally produced in China using Yescarta® technology from Kite Pharma, Inc.


    Lead Product(s): Axicabtagene Ciloleucel

    Therapeutic Area: Oncology Product Name: Yikaida

    Highest Development Status: ApprovedProduct Type: Cell and Gene therapy

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 18, 2023

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    NDA for New Second-Line Indication of CAR T-Cell Therapy Product YIKAIDA (axicabtagene ciloleucel injection) Approved for CDE Review

    Details:

    YIKAIDA (axicabtagene ciloleucel injection) is an autologous CD19-targeted CAR T-cell therapy that was authorized to be locally produced in China using Yescarta® technology from Kite Pharma, Inc.


    Lead Product(s): Axicabtagene Ciloleucel

    Therapeutic Area: Oncology Product Name: Yikaida

    Highest Development Status: ApprovedProduct Type: Cell and Gene therapy

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 27, 2022

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    China's First CAR-T Cell Therapy Approved-Fosun Kite Axicabtagene Ciloleucel (FKC876)

    Details:

    NDA approval is based on results of a single-arm, open label, multi-center bridging trial which has evaluated and proven the efficacy and safety of Axicabtagene Ciloleucel (FKC876) in the treatment of Chinese patients with refractory intermediate invasive DLBCL.


    Lead Product(s): Axicabtagene Ciloleucel

    Therapeutic Area: Oncology Product Name: Yescarta

    Highest Development Status: ApprovedProduct Type: Cell and Gene therapy

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable June 24, 2021

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    Fosun Kite’s New Drug Application (NDA) Filing For Axicabtagene Ciloleucel Accepted For Review By China NMPA

    Details:

    The NDA filing is based on results of a single-arm, open label, multi-center bridging trial (FKC876-2018-001) which has evaluated the efficacy and safety of FKC876.


    Lead Product(s): Axicabtagene Ciloleucel,Cyclophosphamide,Fludarabine Phosphate

    Therapeutic Area: Oncology Product Name: Undisclosed

    Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 24, 2020

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