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    Home > Active Ingredient News > Drugs Articles > Accreditation of optune innovative medical devices granted by the State Drug Administration

    Accreditation of optune innovative medical devices granted by the State Drug Administration

    • Last Update: 2019-08-13
    • Source: Internet
    • Author: User
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    Zaiding pharmaceutical and novocure announced today that China's National Drug Administration has awarded the qualification of optune innovative medical device, a tumor electric field treatment product Tumor electric field therapy is a new treatment method which can interfere with tumor cell division, inhibit tumor growth and make cancer cells affected by electric field die After obtaining the qualification of innovative medical devices, zaiding pharmaceutical will be able to obtain the consultation and suggestions from the technical evaluation center of medical devices under the State Drug Administration in the optune approval process, thus shortening the approval time and accelerating the approval process In September 2018, zaiding pharmaceutical and novocure company reached an exclusive license agreement for tumor electric field treatment in Greater China; later in the same year, optune was successfully listed in Hong Kong for the treatment of glioblastoma; Novocure has been listed in the United States, the European Union, Japan and other countries and regions for the treatment of glioblastoma, and another tumor electric field treatment product novottf-100l is listed in the United States for the treatment of malignant pleural mesothelioma At present, the research of tumor electric field therapy for four solid tumor indications has entered the late stage of clinical development, including non-small cell lung cancer, brain metastasis, pancreatic cancer and ovarian cancer The treatment of tumor electric field has been included in the first "diagnosis and treatment specification for glioma (2018)", and recommended for the treatment of new GBM (Level 1 evidence) and recurrent high-grade glioma (Level 2 evidence).
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