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    Home > Medical News > Medical World News > Anda of Zhengda Tianqing fluvistrone injection was approved and approved for listing in Germany

    Anda of Zhengda Tianqing fluvistrone injection was approved and approved for listing in Germany

    • Last Update: 2020-02-12
    • Source: Internet
    • Author: User
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    On February 11, China biopharmaceutical announced that its subsidiary company Zhengda Tianqing's anti breast cancer drug "fluvectin injection" has been approved by the FDA of the United States and approved by the federal drug and medical device administration of Germany (bfarm) respectively The drug is in the stage of applying for listing in China and is regarded as the application conformity evaluation Fluvastatin is a new type of estrogen receptor antagonist, which can block the nutritional effect of estrogen It is clinically used in postmenopausal breast cancer with estrogen receptor positive, including locally advanced or metastatic breast cancer, which relapses after the adjuvant treatment of anti estrogen or progresses in the treatment of anti estrogen Fluvecan is an ER degradation agent The original manufacturer is AstraZeneca, which was approved for marketing in China in 2010 It is mainly used for locally advanced or metastatic breast cancer of ER + In 2017, fluvastatin injection entered the national medical insurance category B directory through negotiation, and the payment standard of medical insurance was 2400 yuan (5ml: 0.25g / piece), but the renewal failed in the negotiation in 2019 On April 25, 2002, fluvastatin injection was approved by FDA and was used to treat postmenopausal breast cancer patients with worsening condition after treatment with anti estrogen drugs (such as tamoxifen) The global sales volume of the drug in 2018 is US $1.028 billion, which is an important cancer drug of AstraZeneca Sales volume of fluvastatin injection It is difficult to manufacture fluvistrone injection Not only the production process of API is complex, but also the preparation is a complex product of combination of drugs and devices The requirements of R & D process, quality control, production and manufacturing are higher than those of ordinary drugs Zhengda Tianqing's product has been approved in the United States and Germany one after another, and has the qualification to sell the product in the United States and Germany, which will have a positive impact on the group's market expansion in the United States and the European Union In October 2019, fluvistrane injection was listed in one of the 33 varieties of the first batch of encouraged generic drugs.
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