The first new drug "pegabin" of Tebo biology was approved for marketing
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Last Update: 2016-10-05
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Source: Internet
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Author: User
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According to the Fujian food and drug administration, the new biological product "pegabin" (pegylated interferon 2B injection) developed by Xiamen Tebao biological Co., Ltd has recently been officially approved by the State Food and drug administration, and has obtained the drug registration approval and new drug certificate It is reported that this is the first domestic innovative biological product approved by the State Food and Drug Administration this year "Pegobin" is a typical successful example of independent innovation of new drugs in Fujian Province It has completely independent intellectual property rights, and its exclusive 40kdy polyethylene glycol modification technology has global patents The clinical indication of this product is viral hepatitis with huge clinical demand It is the first long-acting interferon approved for marketing in China, breaking the monopoly of similar products abroad and filling the domestic gap On September 13, the "pegabin" GMP certification was publicized on the Internet It is expected that the GMP certificate will be obtained and put into production in October, and the drug sales will be realized within the year It is reported that the variety was approved in 2002, clinical application was submitted in 2007, clinical approval was obtained in 2009, listing application was submitted in 2013, and it was approved in 2016, with a development history of 14 years.
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