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    Home > Medical News > Medicines Company News > Good News|Boji Biomedical Bifunctional Fusion Protein Receives FDA Approval to Enter Clinical Trials

    Good News|Boji Biomedical Bifunctional Fusion Protein Receives FDA Approval to Enter Clinical Trials

    • Last Update: 2021-07-06
    • Source: Internet
    • Author: User
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           Boji Biomedical Technology (Hangzhou) Co.
    , Ltd.
    recently announced that the US FDA has completed the review of the PD-L1/TGFβ bifunctional fusion protein (product code BJ-005) IND independently developed by the company and has a global patent.
    The project can carry out clinical trials in the United States

    This is after Boji Biomedicine obtained the IND approval of the US FDA for its first tumor-targeting IL-15 fusion protein (BJ-001) in 2019, another independently developed product obtained the US FDA's clinical trial approval

    BJ-005 is a humanized anti-programmed death ligand 1 (PD-L1) IgG1 monoclonal antibody (mAb) and human transforming growth factor β (TGF-β) receptor II (TGF-βRII) extracellular domain Part of the fusion is a recombinant bifunctional fusion protein

    The design of BJ-005 allows it to target human PD-L1 and TGF-β at the same time, and inhibit tumor growth by targeting immune checkpoints and regulating tumor cell growth cytokine pathways for the treatment of cancer patients

    The product was approved on time in a single application in the United States, which once again demonstrated the US FDA's recognition of the quality and safety of Boji Biomedical's innovative products


    Zhang Haizhou

           Regarding the approval of the US FDA for BJ-005, Dr.
    Haizhou Zhang, co-founder and CEO of Boji Biomedicine, said: "Our second self-developed product was approved for clinical trials in the United States, which once again proved Boji Biomedical The continuous innovation ability and efficient execution power of

    the company.
    This greatly enhances the company’s confidence in fulfilling the established goal of pushing a completely independent innovation product into clinical research every 1-2 years

    " "Although the field of tumor immunotherapy is fiercely competitive, it is currently at home and abroad.
    There are also many PD-(L)1/TGFβ bifunctional antibodies in the clinical development stage, but considering that combined therapy in this field is a development trend, and BJ-005 and BJ-001 have better anti-tumor properties.
    With synergy, we are confident that BJ's BJ-005 can stand out clinically and benefit more patients at home and abroad

    " Dr.
    Zhang added


           Although it has only been in operation for more than 3 years, but adhering to the concept of only making global independent innovative drugs, Boji Biopharmaceuticals has begun to conduct research on tumors and infectious diseases using its biological drug research and development platform protected by trade secrets and its self-developed dual antibody platform.

    The BJ-005, which was approved to enter the clinic this time, is one of many innovative products in its R&D pipeline

    The first bispecific antibody developed on its own proprietary dual antibody platform is also expected to enter the preclinical development stage this year, and will enter the IND application stage at the end of next year


           About Boji Biomedicine

           Boji Biomedicine is a biotechnology company in the clinical stage dedicated to the research and development of innovative drugs.
    It was founded by returned experts with many years of experience in innovative drug research and development at home and abroad, including review experts for major scientific and technological projects of the country’s “Major New Drug Development” , Possesses an antibody discovery platform protected by trade secrets and advanced technologies at home and abroad.
    Currently, it mainly develops biological drugs for tumors and infectious diseases

    The company's main scientific research and management team has many years of experience in the development and management of macromolecular drugs in national key scientific research institutions and domestic and foreign pharmaceutical companies, especially European and American multinational companies

    Focusing on a global view of R&D and based on strong capital support, Boji Biomedicine has made a global layout for R&D from a global perspective at the beginning of its founding.
    At the same time, it has two R&D laboratories in San Francisco and Hangzhou, China, making the company in the early stage of entrepreneurship.
    It can realize the all-round integration of talents, technology, management and capital market, laying a solid foundation for the company's global positioning and development


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