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    Home > Medical News > Latest Medical News > Boshengji Pharma's CAR-T therapy for neuroblastoma has been granted orphan drug designation by the FDA

    Boshengji Pharma's CAR-T therapy for neuroblastoma has been granted orphan drug designation by the FDA

    • Last Update: 2022-04-25
    • Source: Internet
    • Author: User
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    Transfer from | Medicine Guanlan

    On March 20, Boshengji Pharmaceutical Technology (Suzhou) Co.
    , Ltd.
    (hereinafter referred to as "Boshengji Medicine") announced that the company developed a chimeric antigen receptor (CAR)-T cell injection targeting B7-H3.
    (R&D code: TAA06 injection) has recently been granted orphan drug status by the US FDA for the treatment of neuroblastoma


    The advent of CAR-T cell therapy is an important breakthrough in the field of cancer
    Several CAR-T cell therapy products have been approved worldwide, bringing new options to many blood cancer patients

    However, in the field of solid tumor treatment, CAR-T cell therapy products have not yet achieved breakthroughs

    According to a press release from Boshengji Pharmaceuticals, the main reasons for the poor efficacy of CAR-T products in the field of solid tumors are that the heterogeneity of solid tumors easily leads to treatment escape, and the tumor immunosuppressive microenvironment hinders T cell homing and infiltration.


    Neuroblastoma is one of the most common extracranial solid tumors in children with insidious onset and strong heterogeneity
    Among them, high-risk neuroblastoma is called "the king of childhood tumors" because of its low cure rate

    Because neuroblastoma is a low-immunogenic tumor, the effect of immunotherapy has been poor, and new treatment methods are urgently needed in clinical practice


    In order to solve the above challenges, the R&D team of Boshengji Pharmaceuticals has developed TAA06 injection in a targeted manner
    This is a CAR-T cell injection targeting B7-H3

    B7-H3, a transmembrane protein of the B7 family, is frequently overexpressed in a variety of cancers including lung cancer, prostate cancer, breast cancer, etc.
    , and its overexpression is associated with poor prognosis of patients, which makes B7-H3 a an interesting anticancer target


    According to the press release, Boshengji Medicine intends to develop TAA06 injection for the treatment of neuroblastoma
    In preclinical studies, the drug candidate has achieved good pharmacodynamic and safety data

    In addition, Boshengji Pharmaceutical also stated in the press release that the company has successfully developed a highly optimized fully automatic preparation process, which can effectively control the cost of the product, and improve the access of ordinary children to innovative CAR-T cell drugs.
    Accessibility creates the conditions

    The orphan drug designation granted by the FDA this time is an important research progress for TAA06 injection


    Note: Content has been deleted

    Original title: Boshengji CAR-T product obtained FDA orphan drug designation, targeting neuroblastoma!

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