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    Home > Medical News > Medical Research Articles > New products will be produced on R & D platform of single anti drug of Fosun Pharmaceutical banner

    New products will be produced on R & D platform of single anti drug of Fosun Pharmaceutical banner

    • Last Update: 2020-04-03
    • Source: Internet
    • Author: User
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    According to the website of the State Food and Drug Administration (CFDA) on June 30, Fuhong Hanlin, a subsidiary of Fosun Pharmaceutical holding company, applied for the clinical application of class 2 biological products "recombinant anti VEGF humanized monoclonal antibody injection", which was accepted as the fourth monoclonal antibody declared by the company

    "Recombinant anti VEGF humanized monoclonal antibody injection" is mainly used for the treatment of neovascular (wet) age-related macular degeneration (wet AMD), and is the only complete antibody drug to be used for AMD indications in the world

    The results of preclinical pharmacodynamic study showed that the McAb could significantly inhibit the proliferation of human umbilical vein endothelial cells, and the single administration lasted for more than 28 days, supporting a month or even longer clinical administration cycle

    CFDA shows that at present, there are no domestic enterprises and foreign-funded enterprises to produce the product

    In addition to Fuhong Hanlin, the enterprises applying for clinical approval of the product, there are also two enterprises, Jiangsu Taikang biomedical (accepted in October 2012) and Qilu Pharmaceutical (accepted in May 2013)

    Fuhong Hanlin is a joint venture company established by Fosun Pharmaceutical and Hanlin biopharmaceutical company in December 2009, which is dedicated to the research and development of monoclonal antibody drugs

    The company has previously applied for clinical approval documents of three monoclonal antibody generic drugs, namely, recombinant human mouse chimeric anti-CD20 monoclonal antibody injection, recombinant anti HER2 humanized monoclonal antibody for injection, and recombinant anti TNF α all human monoclonal antibody injection

    The original drugs of the three products are all heavy bomb grade products

    Among them, the first reported monoclonal antibody (CD20) has been approved for clinical use

    A senior executive of Fosun Pharmaceutical has previously said that the company has become one of the largest companies applying for class 2 new drugs of biological products in the country, and has invested hundreds of millions of yuan in the research and development of monoclonal antibodies

    In the future, he will increase his investment and strive to develop 6 or 7 monoclonal antibodies.
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