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    Home > Active Ingredient News > Drugs Articles > Analysis of drug registration in the first half of 2015

    Analysis of drug registration in the first half of 2015

    • Last Update: 2015-07-09
    • Source: Internet
    • Author: User
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    Source: from July 9, 2015, the first half of 2015 passed, and the notice mainly affecting drug registration is the announcement of the State Food and Drug Administration on Issuing the charging standards for registration of drugs and medical devices (No 53, 2015) Whether the number of drug registration declaration will be affected by the charges will be reduced I'm afraid there will be a more obvious data trend in the second half of the year According to the data of Xianda data v3.1 as of July 6, 2015, in the first half of 2015, there were 270 registration (excluding re registration) applications for imported drugs, including 200 clinical applications and 70 production applications The special evaluation of imported drugs is mainly focused on the clinic, with 31 related clinical acceptance numbers, and mainly focused on tumor drugs, such as seretinib capsule, afatinib tablet, lovatinib capsule, etc There are 938 acceptance numbers of new drug applications in China, including 871 chemical drugs, 17 traditional Chinese medicine and all oral drugs, and 32 biological products for treatment In contrast, fewer and fewer Chinese medicine dare to report new drugs 886 out of 938 new drug application acceptance numbers applied for clinical application In the first half of 2015, a total of 12 new drugs were declared as major special projects, including 10 chemicals and 1 biological product for treatment, corresponding to the common names of salvianolic acid A, sph3127, brozopine sodium, furetinib succinate, noratrix hydrochloride and benalutide Among them, benalutide injection and noratrix hydrochloride are approved for production, and the rest are approved for clinical use In terms of special examination and approval, there are 55 acceptance numbers, all of which belong to chemical drugs, of which 51 are applied for clinical application, and the production of Hengrui's retagliptin phosphate tablets and Beijing Kangchen's Nolatrexed hydrochloride are reported There are 286 acceptance numbers for generic drugs, all of which are chemical drugs More imitated products are atorvastatin calcium tablets, esomeprazole sodium for injection, moxifloxacin hydrochloride sodium chloride injection, levetiracetam tablets, tegrilol tablets and rivaroxaban tablets In 2015, the products declared to be approved for production in 2015 are not available One of the approved clinical products is the recombinant Ebola virus vaccine, which has been approved by the military special drug last year In the first half of 2015, a total of 580 clinical acceptance numbers were approved Jiangsu Hengrui is the first in China in terms of obtaining clinical approval documents, with 24 clinical approval documents M6G, shr0302 and shr4640 are all 1.1 types Secondly, Jinan benoxol has obtained 12 clinical approval documents, most of which are 3.1 categories Guanfacine hydrochloride sustained-release tablets are the first approved clinical products in China Shandong new era, Jiangsu Haosen and Sinopharm, etc are following closely The S-metoprolol succinate sustained-release tablets and prasugrel hydrobromide tablets declared by Shandong new era in 2010 and 2011 are the first approved clinical enterprises in China Among them, the three acceptance numbers cxhl1000260 of S-metoprolol succinate sustained-release tablets of Shandong new era were approved for production several days ago, and two were approved for clinical use In 2012, the preparation and certification of everolimus tablets were completed in June In the first half of 2015, Hengrui Pharmaceutical (sh600276), Fosun Pharmaceutical (sh600196) and Kelun Pharmaceutical (sz002422) ranked the top three in terms of the number of drug acceptance numbers declared by listed companies, as shown in the table below If we rank the listed companies by the number of approved clinical approvals in the first half of 2015, as mentioned above, the first is Hengrui Pharmaceutical (sh600276), the second is Hualan Biology (sz002007) and Haizheng Pharmaceutical (sh600267) Ramazolam besylate, a new class 1.1 drug of humanwell Pharmaceutical (sh600079), has been approved for clinical application In 2013, ramazolam toluenesulfonate, a new class 1.1 drug of Hengrui, and its injection were approved for clinical use According to anecdotal reports, this product was also purchased from humanwell medicine Table the three largest domestic listed pharmaceutical manufacturing companies applying for drugs in the first half of 2015 data source: Xianda data v3.1, July 6 Summary: in terms of the number of approved clinical acceptance numbers, 436 were approved in the first half of 2012, 387 in the first half of 2013, 323 in the first half of 2014, 580 in the first half of 2015 This year, the number of approvals reached a new high of nearly four years Is this the beginning of three years to solve the backlog of drug review? Can the new registration fee effectively reduce the repeated declaration? There is still time to prove the above problems In the second half of the year, according to the medical insurance payment price and the price management measures related to generic drugs of the health and Family Planning Commission, the price difference of generic drugs is determined according to the time before and after the approval For example, the price of the first generic drug approved is 80% of the original research drug, the price of the second generic drug approved is 70%, and the price of the fifth generic drug approved is reduced to 50% of the original research drug It is expected that the competition of generic drug declaration will be more fierce, some small and medium-sized enterprises will choose product declaration more carefully, and the total number of declaration will decrease.
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