Insight: CDE drug review report in January 2017

In December, the number of hot spots declared in January 2017 was basically the same as that in the second half of 2016, and the acceptance of CDE review tended to be stable In the first month of 2017, the acceptance of innovative new drugs reached twice that of the same period of last year, and the number of hepatitis C drug danorevir declared for listing in January decreased by about half, only 582 In 2017, 1 The monthly declaration volume is basically the same as that in the second half of 2016, and the acceptance volume of CDE review tends to be stable According to the latest statistics of Insight China Pharma data database of DXY, there were 251 new drug registration applications undertaken by CDE in January 2017 The acceptance volume in the first month of this year is basically the same as that after last year's stabilization, about 260 It can be seen that the acceptance of CDE drug review has been basically stable Next, we will analyze the application acceptance, review and approval of chemical drugs, traditional Chinese medicine and biological products in January 2017 Application acceptance 1 According to insight database statistics, in January 2017, CDE undertook 196 new chemical registration applications with acceptance number, which is not much different from last month The acceptance of each sequence of chemical drug applications is shown in Table 1 In the first month of 2017, the acceptance of innovative new drugs reached twice of the same period of last year According to the statistics of insight database, in January 2017, CDE undertook a total of 20 chemical drug class 1 new drug applications with acceptance numbers, involving 11 varieties In the first month of 2017, 11 varieties of innovative drugs were accepted, significantly higher than only 4 varieties in the same period of 2016 The highest month of innovative drugs in 2016 is August, and only 10 varieties are accepted It is predicted that the application acceptance of innovative drugs in 2017 will increase significantly Let's take a look at the specific varieties of hepatitis C drugs declared and accepted in the first month of 2017 Danorevir, the hepatitis C drug of Geli pharmaceutical, is declared to be on the market Danorevir sodium tablets (asc08) and its APIs are innovative oral drugs for the treatment of hepatitis C danorevir's clinical triple plan for the treatment of hepatitis C patients with genotype I in China 12 Week, the cure rate was over 95% According to insight database query, danorevir was first applied for clinical application by Geli pharmaceutical in April 2014 and approved for clinical application in September of the next year; then it started phase I clinical application in October 2015, phase II clinical application in January 2016 and phase III clinical application in June 2016; and it started in January 2017 The drug is expected to become the first approved hepatitis C treatment drug in China Kl07002, declared by Sichuan Kelun Botai biomedical Co., Ltd., is a new chemical small molecule drug with a new structure, which is intended to be used in the field of anti-tumor In addition to the drug, the company also applied for recombinant anti VEGFR2 all human monoclonal antibody injection for therapeutic biological products, which is also a drug in the field of anti-tumor It can be seen that the holding subsidiary of the Kelun pharmaceutical industry mainly focuses on the research and development of related drugs in the field of tumor Yabao pharmaceutical declared that sy-008 capsule and its API are new oral drugs for the treatment of type 2 diabetes developed in cooperation with Lilly pharmaceutical At present, there is no drug with the same target as the drug on the market There is no news about other drugs 2 In January 2017, CDE undertook 32 applications for generic drugs with acceptance number, involving 23 varieties Among them, there are 14 generic drugs declared according to the old 6 categories with acceptance number, involving 11 varieties; there are 8 generic drugs declared according to the new 4 categories with acceptance number, involving 6 varieties There are 10 generic drugs declared according to the new 3 categories with acceptance number, involving 6 varieties They are respectively 3 In January 2017, CDE undertook 17 new chemical import registration applications with acceptance number, involving 13 varieties in total Among them, there are 9 applications with acceptance number in category 5.1, involving 6 varieties There are 4 types of applications with acceptance number, involving 4 varieties This month, only one imported chemical drug was declared to be imported in China for the first time It is the cabotegravir tablet and cabotegravir suspension injection declared by GlaxoSmithKline At present, the drug has carried out phase III clinical trials (nct02720094) in Thailand and the United States to treat HIV 2 In January 2017, CDE undertook 19 new applications of traditional Chinese medicine with acceptance number, including 1 new drug application (involving 1 variety), 12 supplementary applications (involving 12 varieties) and 6 import re registration (involving 6 varieties) III in January 2017, CDE undertook 36 new applications for biological products with acceptance number Among them, 5 new drug applications (involving 5 varieties), 7 import applications (involving 5 varieties) and 24 supplementary applications (involving 17 varieties) This month, there are two new biological products of category 1, which are review and approval status 1 Overall review and approval status In January, the number of completed reviews decreased by about half, only 582 According to the advanced screening of insight database, in January 2017, a total of 582 acceptance numbers completed the review The total number of completed reviews was nearly half of that of last December's 963; the number of completed reviews of chemicals, traditional Chinese medicine and biological products was all down compared with last month It can be seen that the Spring Festival holiday has a great impact on the evaluation efficiency of CDE 2 Review and approval of each review sequence of chemical drugs: in January 2017, 498 chemical drug acceptance numbers completed the review As shown in Figure 8, compared with the previous two months, the number of completed reviews of each sequence in January decreased by nearly half, while that of ind, NDA and confirmatory clinic increased slightly Supplementary applications are down from last month The overall review volume has declined significantly It depends on whether the chemical drug review can keep up with the pace after the beginning of February 3 Class 1.1 and new class 1 new drugs according to insight database statistics, there were 15 old class 1.1 and new class 1 new drugs approved in January 2017, involving 40 acceptance numbers In the first month of this year, the number of old 1.1 and new 1 drugs increased significantly, compared with about 30 drugs per month at the end of last year The details are as follows: 4 Review and approval of class 1 biological products According to insight database, there was one class 1 biological product approved in January 2017, involving two acceptance numbers Specifically, the kh906 eye drops declared by Chengdu Kanghong Biotechnology Co., Ltd are intended to be used for the treatment of ocular surface neovascularization.