May 2016 CDE drug review report

In May, the hot spot was declared again in May, reaching a new low for nearly six months Zaiding pharmaceutical cooperated with South Korea and the United States Zl-2303 applied for acceptance of Lilly anti-tumor drug merestinib applied for import of approved clinical class 1.1 new drugs According to the latest statistics of Insight China Pharma data database of DXY, may 2016 CDE has undertaken 298 new drug registration applications with acceptance number, reaching a new low of nearly six months The following is an analysis of the application acceptance, review and approval of chemical drugs, traditional Chinese medicine and biological products in May 2016 Application acceptance situation 1 Chemical application in may hit a new low of nearly six months again According to the statistics of insight database, in May 2016, CDE undertook 242 new chemical registration applications with acceptance number, down from last month 1 New drug (1) 1.1 new drug zaiding Pharmaceutical Co., Ltd cooperates with Korean and American pharmaceutical According to the statistics of insight database, in May, CDE undertook a total of 27 chemical drug 1.1 new drug applications with acceptance number, involving 9 varieties, all of which are clinical applications In May, Hubei Biomedical Industry Technology Research Institute Co., Ltd applied for two new drugs, wxfl10040340 and wxfl10230486, class 1.1 Wxfl10230486 is a Btk inhibitor, which is mainly used in the treatment of rheumatoid arthritis, but wxfl10040340 has no information Hmpl-689 was declared by Hutchison Whampoa Pharmaceutical Co., Ltd., which has carried out phase I clinical trials in Australia, mainly for the treatment of malignant hematopathy Zl-2303 declared by zaiding pharmaceutical was introduced from South Korea and the United States to hm61713 for lung cancer treatment, which has been listed in South Korea Based on the results of phase I / II clinical trials of hm61713, FDA awarded its breakthrough drug qualification at the end of 2015 Earlier, South Korea and the United States licensed hm61713's commercial rights outside South Korea and China to German pharmaceutical company bringer Ingelheim Cbp-307, developed by Conrad biomedical, has completed phase I clinical trials in Australia It is mainly used for the treatment of autoimmune diseases Suzhou Zejing is a biomedical company that provides technical services, technical development and technical consultation in the field of biotechnology The reported antineoplastic agent is also the second class 1.1 new drug after the antineoplastic agent donafinil toluene sulfonate declared by the company in December 2011 At present, there is no information about wx-0593 of Qilu pharmaceutical, hy-021068 of Hefei medical industry pharmaceutical and yzj-1139 of Yangzi pharmaceutical (2) In May 2016, CDE undertook a total of 28 applications for new chemical drugs of category 3.1, including 24 clinical applications and 4 listing applications 2 In May 2016, CDE undertook 56 applications for new generic drugs with acceptance number, down from last month 3 Merestinib, an anti-tumor drug imported from Lilly, declared for import in May 2016 CDE undertook 15 new chemical import registration applications with acceptance number, down from last month All applications involved 11 varieties This month, only one imported chemical was declared in China for the first time Merestinib, an anti-tumor drug of Eli Lilly, is a small molecule multi kinase inhibitor, which can selectively block the signal transmission of met, mst1r (RON), Axl and mknk1 / 2 in vitro Combined with imcgp100 and galunisertib, the treatment of metastatic cutaneous melanoma has been carried out to phase II clinical trials in the United States 2、 In May 2016, CDE undertook 18 new applications of traditional Chinese medicine with acceptance number, including 2 re registration of imports, 2 new drug applications, 1 review application and 13 supplementary applications 3、 In May 2016, CDE undertook 29 new applications for biological products with acceptance number Among them, there are 11 new drug applications, 2 import applications, 12 supplementary applications and 4 import re registration applications There are three class 1 new drugs in the new drug application: review and approval 1 The overall review and approval are based on the advanced screening of insight database In May 2016, a total of 1022 acceptance numbers completed the review (including acceptance numbers entering the approval stage and existing review conclusions) The total number of completed reviews was basically the same as that of last month, but it was more than three times the number of applications accepted The proportion of completed reviews of traditional Chinese medicine and biological products decreased 2 In May 2016, 964 chemical acceptance numbers completed the review As shown in Figure 4, the number of completed reviews of Anda sequences and supplementary applications increased in May, while the number of reviews of confirmatory clinical applications decreased by nearly half 3 Review and approval of class 1.1 new drugs the number of class 1.1 new drugs in the approved clinic decreased according to insight database statistics In May, there were 3 class 1.1 new drugs in the approved clinic, involving 5 acceptance numbers 4 Review and approval of class 1 biological products in May, a class 1 biological product was approved for clinical use The recombinant human urokinase for injection from Shanghai Tianshili Pharmaceutical Co., Ltd was mainly used for the treatment of myocardial infarction Tianshili's recombinant human urokinase for injection was first approved for production in 2011 and is the exclusive production and sales