Analysis report on CDE drug review in April 2019

Highlights: 1 The total number of drug audit centers accepted this month is 527 (excluding reexamination) 2 This month, 25 new chemical drugs of category 1 were accepted by CDE 3 This month, 52 acceptance numbers of application according to the quality and efficacy consistency evaluation varieties of generic drugs were added According to the latest statistics of drug intelligence data, in April 2019, CDE undertook 527 new drug registration applications with acceptance number (excluding reexamination, the same below) Figure 1: the total acceptance of CDE drugs in January April 2019 is 14.45% less than that in March Among them, there are 46 chemical drugs, 41 traditional Chinese medicine and 70 biological products Let's take a look at the registration, acceptance and evaluation of chemical drugs, traditional Chinese medicine and biological products 1、 In April, CDE undertook 416 new chemical registration applications with acceptance number Fig 2 acceptance of CDE chemical drugs in various application types from January to April 2019 from the perspective of chemical drugs declaration, the undertaking data of this month is lower than that in March 1 The CDE has accepted 14 acceptance numbers of domestic class 1 new drugs of chemical drugs this month, involving 6 varieties and 5 enterprises The following table shows the new class 1 drugs in April Table 1 new chemical class 1 drugs newly undertaken in April 2019 note: the queue number is up to April 29, 2019 Ast-3424: ast-3424 is a new anticancer drug initiated and developed by Dr Duan Jianxin, chairman of aixindawei It has the characteristics of targeting a variety of tumors, especially the high expression of akr1c3 in the drug-resistant tumor microenvironment, accurately and highly selective release of strong DNA alkylating agent to kill tumor cells Ast-3424 can also be used to measure akr1c3 expression by immunostaining, so as to select patients with high akr1c3 expression 2 The declaration of class 1 imported chemicals was undertaken this month with 12 acceptance numbers of class 1 imported chemicals Table II notes to newly undertaken imported chemical drugs of category 1 in April 2019: the queue number is up to April 29, 2019 2、 In April, CDE undertook 41 new TCM registration application acceptance numbers, 39 for supplementary applications and 2 for new drugs Figure 3: CDE's acceptance of traditional Chinese medicine from January to April 2019 3 Review of biological products In April, CDE undertook 70 new biological product registration application acceptance numbers, 17 new drugs, 29 supplementary applications and 18 imports Figure 4 acceptance of CDE biological products from January to April 2019 10 biological products for treatment of category 1 were accepted this month, and now they have entered the corresponding queue for review Table 3 new class 1 drugs of therapeutic biological products newly undertaken in April 2019 note: the queue number is up to April 29, 2019 4、 The acceptance numbers of varieties declared according to conformity assessment in this month are 23.5% less than those of 68 in April, and 52 acceptance numbers declared according to conformity assessment are added Figure V acceptance quantity of consistency assessment from January to April 2019 Table IV acceptance number of new consistency assessment in April 2019 data source: drug intelligence data