[exclusive] analysis report on CDE drug review in May 2019

Highlight: the total number of drug examination centers accepted this month is 607 (excluding reexamination) This month, 19 new chemical drugs of class 1 were accepted by CDE This month, 76 acceptance numbers were added according to the quality and efficacy consistency evaluation varieties of generic drugs According to the latest statistics of drug intelligence data, in May 2019, CDE undertook 607 new drug registration applications with acceptance number (excluding reexamination, the same below) (Note: the appendix of the report is attached at the end of the article, which can be downloaded and read.) Figure 1: the total acceptance of CDE drugs in January may 2019 increased by 15.18% compared with April Among them, 509 are chemical drugs, 26 are traditional Chinese medicine and 72 are biological products Let's take a look at the registration, acceptance and evaluation of chemical drugs, traditional Chinese medicine and biological products 1、 In May, CDE undertook 509 new chemical registration applications with acceptance number Fig 2 acceptance of CDE chemical drugs in various application types from January to may 2019 from the perspective of chemical drugs declaration, the undertaking data of this month is higher than that in April, except for one-time import 1 The CDE has accepted 32 acceptance numbers of domestic class 1 new drugs of chemical drugs this month, involving 11 varieties and 11 enterprises The following table shows the new class 1 drugs in May Table 1 new chemical class 1 drugs newly undertaken in May 2019 note: the queue number is up to May 31, 2019 Apg-115 capsule: apg-115 is the first clinical MDM2-p53 inhibitor in China P53 gene is the most widely studied tumor suppressor gene The inactivation of p53 gene plays an important role in tumor formation, and MDM2 is the most important inhibitor of p53 When the two are combined, it will degrade the p53 protein, reduce the activity, and weaken the anti-cancer effect It is one of the hotspots and emphases in the field of tumor drug research and development in the world to design and develop new mechanisms of antitumor drugs with MDM2-p53 as the target However, due to the particularity of MDM2-p53 protein interaction, it is very difficult to develop small molecule inhibitors, which leads to a small number of drugs in research in this field in the world There are no drugs on the market for this target in the world, but there are no other reports in this field except apg-115 in China Act001 capsule: act001 won the status of "orphan drug" in the United States, and won the status of "orphan drug" in the European Union without defense Indications include: glioblastoma of brain (GBM) and autoimmune diseases (including rheumatoid arthritis / lupus erythematosus / optic neuromyelitis, etc.) 2 The declaration of class 1 imported chemical drugs 16 acceptance numbers of class 1 imported chemical drugs were undertaken this month Table II notes to newly undertaken imported chemical drugs of category 1 in May 2019: the queue number is up to May 31, 2019 2、 In May, CDE undertook 26 new applications for registration of traditional Chinese medicine, all of which were supplementary applications Figure 3: CDE acceptance of traditional Chinese medicine from January to may 2019 3 Review of biological products In May, CDE undertook 72 new biological product registration application acceptance numbers, 13 new drugs, 35 supplementary applications and 10 imports Figure 4 acceptance of CDE biological products from January to may 2019 10 biological products for class 1 treatment were accepted this month, and all of them have entered the corresponding queue for approval Table 3 new class 1 drugs of therapeutic biological products newly undertaken in May 2019 note: the queue number is up to May 31, 2019 4、 The number of acceptance numbers declared according to conformity assessment in this month increased by 46.15% compared with 52 in April, and 76 acceptance numbers declared according to conformity assessment requirements Figure V acceptance quantity of consistency evaluation from January to may 2019 Table IV acceptance number of new consistency evaluation in May 2019 data source: drug intelligence data annex: (1) analysis report on CDE drug review in may 2019.pdf 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.