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    Home > Medical News > Latest Medical News > [inventory] Q3, 2018: 20 new drugs approved by FDA, 17 andas added by Chinese pharmaceutical companies

    [inventory] Q3, 2018: 20 new drugs approved by FDA, 17 andas added by Chinese pharmaceutical companies

    • Last Update: 2018-10-08
    • Source: Internet
    • Author: User
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    In the third quarter of 2018, 20 new drugs were approved by FDA In the third quarter of 2018, 20 new drugs were approved by FDA drug review and Research Center (CDER), which is the same as the number of new drugs approved in the first half of 2018 These new drugs include new molecular entities (NME) and biological products licensing applications (BLA) in new drug application NDA Table 1: 20 new drugs approved in the third quarter of 2018 (rareor "orphan" diseases) 13 of the 20 new drugs approved in the third quarter of 2018 obtained orphan drug qualification (o), accounting for 65% of new drugs approved by CDER There are two characteristics of rare diseases, one is the small number of patients The United States has fewer than 200000 diseases; the European Union has 5 in 10000 The second is serious diseases endangering life and health Priority review if the CDER determines that the drug has the potential to make a substantial contribution to health care, the drug will be given priority review The drug is reviewed within 6 months instead of the standard 10 months In the third quarter of 2018, 12 of the approved new drugs were identified as priority review (P), accounting for 60% of the approved new drugs CDER uses a variety of regulatory methods to accelerate the development and approval of new drugs In addition to the priority review, these methods include: fast track, breakthrough and accelerated approval In the field of treatment, in the third quarter of 2018, there were relatively few antineoplastic drugs, only 5 On the whole, the US FDA is also the first choice for drug companies to list new drugs 15 of the 20 new drugs are the first batch in the world, and most of the rest are in the first batch in the EU and Japan The figure below shows the number of new drugs approved by CDER every year in the past 10 years A total of 6 Blas and 14 NMES were approved by CDER in the third quarter of 2018 As a result, the number of new drugs approved by CDER reached as many as 40 in the first three quarters of 2018 According to the current approval rate, it is expected to exceed 2017 in the whole year, setting a new record In the third quarter of 2018, the Anda approved by Chinese pharmaceutical companies in the third quarter of 2018, the Anda approved by the FDA added 17 application numbers, a total of 14 active ingredients, from 12 Chinese pharmaceutical companies In terms of enterprises, Huahai Pharmaceutical Co., Ltd won the most anda in the third quarter, totaling 5 Table 2: in the third quarter, the Anda with red icon on the Anda approved by the FDA of Chinese pharmaceutical enterprises is provisional approval, and there are only four in the third quarter of 2018 FDA's provisional approval means that it cannot be listed in the U.S due to patent rights and / or exclusivity, but it meets FDA quality, safety, and effectiveness standards for listing in the U.S By the end of the third quarter, the total number of andas approved by the FDA by Chinese enterprises in 2018 has reached 49, which has exceeded 44 in 2017, a record high In addition, the dividend of China and the United States is more and more obvious and the pace of internationalization of Chinese pharmaceutical enterprises is more and more firm In the future, more enterprises may go to the United States to apply Statement: this opinion only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.
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