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    Home > Active Ingredient News > Drugs Articles > Tenofovir's market competitiveness of hepatitis B in China has been greatly improved

    Tenofovir's market competitiveness of hepatitis B in China has been greatly improved

    • Last Update: 2017-05-25
    • Source: Internet
    • Author: User
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    [China Pharmaceutical network enterprise news] tenofovir is an oral nucleoside antiviral drug developed by Gilead, which was listed in the United States in 2001 In 2011, guangshengtang and other enterprises challenged Gilead, the holder of tenofovir, and in 2016, the core preparation of Gilead tenofovir On May 24, 2017, guangshengtang received the upload registration approval of tenofovir maleate capsules issued by the State Food and drug administration (tenofovir's first domestic imitation of the approved GST hepatitis B market competitiveness has been greatly improved picture source: Baidu picture) On May 22, the website of the State Food and Drug Administration updated the approval status of tenofovir fumarate dipivoxil capsule of guangshengtang, with the drug approval number of h20170005, which represents the approval of domestic tenofovir, which is used to treat hepatitis B as the first imitation Guangshengtang announced in the afternoon on the 24th that the company has received the registration approval for the production of tenofovir fumarate and tenofovir fumarate capsules issued by the State Food and drug administration Since obtaining the clinical approval document on October 11, 2011, guangshengtang has successively carried out the human pharmacokinetic test, multicenter randomized controlled double-blind test and open-ended test of the drug As the project management and supervision partner of the three clinical trials, Boji pharmaceutical, together with the application enterprises, 14 clinical units and testing institutions, has been active and rigorous in three years Right time completed the first two trials mentioned above, and obtained the "head-to-head" test data of tenofovir and entecavir in the world The clinical research results are consistent with the original research results of tenofovir, which provides strong data support for the clinical medication of Chinese patients, and accepted the strict field verification of CFDA clinical trial data in 2016 and passed smoothly Tenofovir, an oral nucleoside antiviral drug developed by Gilead, was marketed in the United States in 2001 (trade name Viread) With the advantages of good curative effect, low drug resistance and convenient administration, it has become the first-line long-term drug for hepatitis B recommended by major clinical treatment guidelines, with a peak annual sales volume of more than US $1 billion In 2008, the drug entered China as an AIDS drug, and in 2014, it expanded the indications of hepatitis B However, under the original research protection and market monopoly, the price of Viread is as high as 1500 yuan / month (300mg × 30 tablets / bottle), and it is not within the scope of medical insurance reimbursement, so it is hard for ordinary families of hepatitis B patients in China to bear Guangshengtang and other enterprises have challenged Gilead, the holder of tenofovir, since 2011, and successfully challenged Gilead tenofovir core preparation (application No.: 2007101962653) in 2016 As a domestic tenofovir approved for treatment of hepatitis B, guangshengtang has become a domestic pharmaceutical company which has two major first-line drugs for hepatitis B, entecavir and tenofovir Its competitiveness in the domestic hepatitis B market has been greatly improved.
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