Analysis report on CDE drug review in May 2017

Highlights: in May, there were 378 new acceptance numbers undertaken by CDE (excluding 13 reviews, counting by acceptance numbers, the same below) In this month, CDE accepted 36 acceptance numbers of chemical drugs of category 1, involving 14 varieties and 14 manufacturers This month, Jiangsu Hengrui received 3 kinds of class 1 chemicals, namely shr7280, shr9146 and shr0532 According to the statistics of pharmaceutical intelligence data, in May 2017, there were 378 new drug registration applications undertaken by CDE with acceptance number, up 109 from 269 in April 2017 In the first five months of 2017, the number of applications kept rising in the first three months, down in April, and peaked in May Up to now, 9 drug acceptance numbers declared in May are in the status of mailing, 314 are in the status of review and approval, and 14 are in the status of acceptance Among them, 75 cases were reported for clinical use and 33 cases for production (statistical time: June 1, 2017) Figure 1: CDE drug acceptance from January 2017 to may 2017 Figure 2: pharmacological classification of CDE drug acceptance in May 2017 picture source: automatic analysis of drug intelligence data visualization Figure 3: ranking of CDE drug acceptance enterprises in May 2017 picture source: automatic analysis of drug intelligence data visualization Next, we will analyze the application and acceptance of chemical medicine, traditional Chinese medicine and biological products I chemical medicine according to the statistics of pharmaceutical intelligence data, in May 2017, CDE undertook 289 new chemical medicine registration applications with the acceptance number It is 80 more than 209 last month Figure 4: acceptance of various application types of CDE chemical drugs in May 2017 1 Application of new chemical drugs of category 1 According to the statistics of pharmaceutical intelligence data, in May 2017, CDE accepted a total of 36 acceptance numbers of new chemical drugs of category 1, involving 14 varieties and 14 manufacturers This month, the number of chemical category 1 applications increased from April 23 Table 1 New chemical class 1 drugs newly undertaken in May 2017 note: as of June 1, 2017, Jiangsu Hengrui Pharmaceutical Co., Ltd applied for three chemical class 1 varieties with a total of 7 acceptance numbers Three varieties of shr7280, shr9146 and shr0532 were tablets In the past year, Jiangsu Hengrui has applied for 34 (18 independent products) and approved 4 Shr7280 is a gonadotropin releasing hormone (GnRH) antagonist developed for the treatment of endometriosis Shr9146 is an oral, powerful small molecule Ido inhibitor, which is an important small molecule regulatory target in tumor immunotherapy According to the data, there is no Ido inhibitor listed at home and abroad Epacadostat (incb024360) developed by Incyte company is in phase III clinical research stage in the United States; gdc-0919 jointly developed by newl ink company and Roche company is in phase I clinical trial stage in the United States; no similar drug in China is in clinical research stage or on the market 2 Declaration of chemical and generic drugs According to the statistics of pharmaceutical intelligence data, in May 2017, CDE undertook a total of 25 applications for chemical drug imitation with acceptance number (involving 17 varieties), including 14 applications for generic drugs according to the old 6 categories (involving 9 varieties), 7 applications for new 4 categories (involving 5 varieties), and 4 applications for generic drugs according to the new 3 categories (involving 4 varieties) Table II new chemical drugs accepted by CDE in May 2017 note 3 Declaration of imported chemical drugs as of June 1, 2017 According to the statistics of pharmaceutical intelligence data, in May 2017, CDE undertook 23 new chemical import registration applications with acceptance numbers, including 5 acceptance numbers (involving 3 varieties) for class 1 chemical drugs, 3 acceptance numbers (involving 2 varieties) for class 2.4 chemical drugs, 3 acceptance numbers (involving 3 varieties) for class 5.1 chemical drugs, and 7 acceptance numbers (involving 7 varieties) for class 5.2 chemical drugs Table 3 New chemical category 1 imported drugs undertaken in May 2017: by the end of June 1, 2017, Bayer pharmaceutical had applied for neladenson hydrochloride tablets of chemical category 1, with acceptance numbers of jxhl1700097, jxhl1700098 and jxhl1700099 Bay1067197, a new oral, highly selective partial agonist of adenosine A1 receptor, is intended to be used in the treatment of chronic heart failure (CHF) At present, phase II clinical research is underway, and it is in the recruitment state 2 Traditional Chinese medicine According to the statistics of intelligence of medicine, in May 2017, CDE undertook a total of 24 applications for new registration of traditional Chinese medicine, up from 16 in April, including 3 new drugs, 1 re registration for import and 20 supplementary applications (involving 20 varieties and 19 manufacturers) Table 4 New Chinese medicine new drugs undertaken in May 2017 note: queue number up to June 1, 2017 3 Biological products According to the statistics of pharmaceutical intelligence data, in May 2017, CDE undertook 64 new biological product registration application acceptance numbers, 15 new drugs (involving 15 varieties), 9 imports (involving 9 varieties), and 40 supplementary applications (involving 19 varieties) Table 5 new class 1 biological products in May 2017 note: queue No up to June 1, 2017