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    Home > Active Ingredient News > Drugs Articles > In 2019, priority review, review and approval of a large inventory of chemical drugs, biological drugs...

    In 2019, priority review, review and approval of a large inventory of chemical drugs, biological drugs...

    • Last Update: 2019-12-17
    • Source: Internet
    • Author: User
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    At the end of 2019, nearly 100 varieties of national CDE have been put into the priority review and approval channel, of which the number of chemical drugs is significantly higher than that of biological drugs, and the proportion of innovative and imported varieties is nearly 50%, and most of the included varieties are in the production reporting status, covering many large varieties in the field of tumor and rare diseases, with a relatively high degree of attention! In February 2013, the former CFDA (now nmpa) issued the opinions on deepening the reform of drug review and approval to further encourage drug innovation, which proposed to speed up the review of innovative drugs and children's drugs, and to review the priority of generic drugs urgently needed in clinical and in short market This is the first time that the priority review was put forward in the document In November 2015, the former CFDA issued the announcement on several policies of drug registration review and approval, which clearly proposed to formulate and issue the relevant policies of priority review and approval, encourage the research and development and production of drugs with market shortage and innovation, and put the priority review system construction on the agenda In February 2016, the former CFDA officially issued and implemented the opinions on priority review and approval for solving the backlog of drug registration applications, clearly proposing to accelerate the research and development of new drugs with clinical value and clinical urgent need of generic drugs in the current situation of review backlog By the end of the year 2019, 8 new chemical drugs (including imported ones) have been included in the priority review Currently, 8 new chemical drugs (including imported ones) have been included in the priority review, and they are all in the NDA stage In chronological order, they are ensatinib, hazemab, sinamode, ometinib, rimazolen toluene sulfonate, hsk3486, l-ornidazole ester and imitavir Among them, Guan The varieties with relatively high degree of injection were ometinib and ensatinib The application enterprises involve large domestic pharmaceutical enterprises such as Beida, Haizheng, hausen, Hengrui, hisic, Yangzi River, dongyangguang, etc In 2019, there are 4 new chemical drugs (2.2 & 2.4) included in the priority review, all of which are in the NDA stage In chronological order, they are entecavir granules, maxitan tablets, chloral hydrate / syrup combination packaging, nedanib ethanesulfonate soft capsule Among them, although entecavir belongs to a large variety in China, its profit space has been greatly reduced after "4 + 7" In 2019, there are 7 imported chemical drugs (5.1) which are currently included in the priority review, in chronological order: pratraxar injection, apalumide tablet, avatrappa tablet, edaravone sodium chloride injection, trimetinib tablet, dalafeni capsule and radium chloride [223ra] injection Among them, aparumide has been approved for import Table 1: by the time of publication, the "chemical drugs category 1, 2 and 5.1" varieties included in the priority review and approval in 2019 have been included in the priority review and approval In 2019, there are 24 chemical drugs category 3 generic varieties currently included in the priority review and 28 chemical drugs category 4 generic varieties currently included in the priority review, all of which are domestic pharmaceutical enterprises Among them, the number of imitated varieties of humanwell pharmaceutical included in the priority review was the largest, including 4: norvenlafaxine succinate sustained-release tablets, midazolam oral solution, bupropion hydrochloride sustained-release tablets, metformin hydrochloride sustained-release tablets Other enterprises, such as Shiqiao biology, Yiling biology, Chengdu Yuandong biology, Lizhu group, Shanghai xuantai Haimen Pharmaceutical Co., Ltd., Sichuan Huiyu Pharmaceutical Co., Ltd., have two varieties included in the priority review Table 2: "chemical drugs of Category 3 and 4" included in the priority review in 2019 were included in the priority review and approval of biological drugs by the time of publication The biological drugs currently included in the priority review in 2019 are mainly biological products for treatment, and most of them are anti-tumor monoclonal antibodies Among them, the main varieties declared as "imported biological products for treatment" are navulizumab, pabolizumab, patozumab, scuchiumab, cetuximab, etc "Therapeutic biological products of class 1, class 2 and class 15" mainly include tirellizumab, carrellizumab, recombinant human Newland green, Adamu mAb, bevacizumab, rituximab, trastuzumab, etc In terms of enterprises, Xinda biology, Fuhong Hanlin and Roche (China) have a relatively large number of varieties included in the priority review and approval of biological drugs Table 3: data sources of biological drug varieties included in the priority review in 2019: 1 Nmpa official website 2 CDE official website 3 Yaozh data 4 Official website information of major companies
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