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    Home > Medical News > Medical Research Articles > Application for clinical acceptance of recombinant anti HER2 humanized monoclonal antibody for injection in uniform pharmaceutical

    Application for clinical acceptance of recombinant anti HER2 humanized monoclonal antibody for injection in uniform pharmaceutical

    • Last Update: 2020-04-03
    • Source: Internet
    • Author: User
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    The company and all directors guarantee that the content of information disclosure is true, accurate and complete without any false record, misleading statement or major omission

    Sinopharm group united Pharmaceutical Co., Ltd

    (hereinafter referred to as "The company") holds 35.19% of shares in Shenzhen Wanle Pharmaceutical Co., Ltd

    (hereinafter referred to as "Wanle pharmaceutical") and develops a new drug, recombinant anti HER2 humanized monoclonal antibody for injection

    After submitting materials to Guangdong food and Drug Administration and completing on-site verification, its clinical application has been officially accepted by the State Food and drug administration

    Recombinant anti HER2 humanized monoclonal antibody for injection is a kind of recombinant DNA humanized monoclonal antibody, which is one of the targeted drugs for clinical treatment of breast cancer at present "Herceptin" of Taike company was listed in China in 2002

    So far, no domestic similar drugs have been listed

    Whether the above new drug application of Wanle pharmaceutical can pass the clinical review and obtain the approval document is uncertain, and there is great uncertainty in the approval progress and results

    Even if the above-mentioned new drugs have obtained clinical approval documents, they only show that clinical research can be started

    However, the clinical trials of new drugs are generally divided into three stages, with different periods

    It will take several years to conservatively estimate the whole clinical stage, so investors should pay attention to the investment risks

    The company will timely perform information disclosure obligations according to its subsequent progress

    The board of directors of Guoyao group united Pharmaceutical Co., Ltd

    July 29, 2014
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