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    Home > Medical News > Medical Research Articles > Guilin Sanjin Pharmaceutical Co., Ltd. obtained approval for clinical trial on recombinant anti EGFR human mouse chimeric monoclonal antibody injection

    Guilin Sanjin Pharmaceutical Co., Ltd. obtained approval for clinical trial on recombinant anti EGFR human mouse chimeric monoclonal antibody injection

    • Last Update: 2020-04-03
    • Source: Internet
    • Author: User
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    Guilin Sanjin (SZ: 002275): Recently, it was announced that the recombinant anti EGFR human mouse chimeric monoclonal antibody injection was approved for clinical trial, Guilin Sanjin Pharmaceutical Co., Ltd

    (hereinafter referred to as "the company") has received the approval of the State Food and Drug Administration (hereinafter referred to as "the State Food and Drug Administration") for the clinical trial of the recombinant anti EGFR human mouse chimeric monoclonal antibody injection

    We hereby announce the following information: 1

    Main contents of clinical trial approval document: drug name: recombinant anti EGFR human mouse chimeric monoclonal antibody injection approval document No.: 2016l06884 dosage form: injection specification: 100mg (20ml) / bottle application items: new drug applicant: Guilin Sanjin Pharmaceutical Co., Ltd., Baoshan biomedical technology (Shanghai) Co., Ltd

    Acceptance Number: cxsl15000090 GUI Registration classification: examination and approval conclusion of biological products for treatment: according to the drug administration law of the people's Republic of China and relevant regulations, after examination, the product meets the relevant requirements of drug registration and is approved for clinical trial

    2、 The drug development and related information recombinant anti EGFR human mouse chimeric monoclonal antibody injection is an antibody drug targeting epidermal growth factor receptor, which is used for the treatment of patients with metastatic colorectal cancer and head and neck cancer

    The product has been developed jointly by ImClone systems, Merck KGaA and Bristol Myers, It was listed in the United States in 2004 and entered the Chinese market in 2005

    In 2015, its global sales exceeded 1.5 billion US dollars

    In China, no similar products have been approved for listing

    On September 1, 2015, the company submitted the application for clinical registration to the State Food and Drug Administration and was accepted

    Next, the company will carry out the clinical trial study of recombinant anti EGFR human mouse chimeric monoclonal antibody injection as soon as possible in accordance with the requirements of the above-mentioned drug clinical approval documents

    In the future, the company will continue to accelerate the research and development of other varieties under research of Baosteel bio, laying a solid foundation for the company to further deepen the strategic layout of biopharmaceutical and improve its overall competitiveness

    New drug research and development is a long-term work, affected by technology, approval, policy and other factors

    There are many uncertainties in the progress and results of clinical trials, and the market competition situation of future products

    Please pay attention to the investment risks.
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