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

Highlight: this month, the total number of drug examination centers accepted is 568 (excluding reexamination) This month, 19 new chemical class 1 drugs have been accepted by CDE, and one of them has applied for listing This month, 73 new acceptance numbers were applied for according to the quality and efficacy consistency evaluation varieties of generic drugs According to the latest statistics of drug intelligence data, in February 2019, CDE undertook 568 new drug registration applications with acceptance number (excluding reexamination, the same below) Figure 1: the total acceptance of CDE drugs in February 2019 is 2 more than that in February 2018 Affected by the Spring Festival, it decreased by 37.2% compared with January, including 458 chemical drugs, 29 traditional Chinese medicines and 79 biological products Let's briefly analyze the registration acceptance and review of chemical drugs, traditional Chinese medicine and biological products (Note: the full PDF version of the report is attached at the end of the paper.) 1 In February, CDE undertook 458 new chemical registration applications with the acceptance number Figure 2 acceptance of CDE chemical drugs in January and February 2019 from the perspective of chemical drugs declaration, the undertaking data of this month is lower than that of January 1 Application of new chemical medicine category 1 CDE accepted 35 acceptance numbers of new chemical medicine category 1 this month, involving 11 varieties and 11 enterprises The figure below shows the newly undertaken class 1 new drugs in February Table 1 new chemical class 1 drugs newly undertaken in February 2019 note: the queue number is up to March 1, 2019 GST-HG151 Through the specific combination with the corresponding target, it can prevent the activation of JNK (c-Jun amino terminal kinase) and p38MAPK (mitogen activated protein kinase) pathways downstream of the target, so as to reduce the occurrence of apoptosis and fibrosis It has the characteristics of good target selectivity, strong drug-making, significant efficacy and high safety It is used to evaluate Nash or liver fibrosis animal models before clinical It shows the effect of improving liver function and statistically significant anti fibrosis effect At present, there is no effective treatment for NASH The development of gst-hg151 project is expected to fill the gap in the field of global liver fibrosis and overcome the world's irreversible problems of liver fibrosis and cirrhosis Acc010 can inhibit the growth rate of all solid tumors Such as lung cancer, liver cancer, breast cancer, colorectal cancer and so on Compared with azd2281 (olaparib), imp4297 has higher activity, stronger antitumor effect and better safety 2 The application of class 1 imported chemicals this month, a total of 10 class 1 acceptance numbers of imported chemicals have been undertaken, including one class 1 new drug of a variety of chemicals applied for listing Table II notes to newly undertaken imported chemical drugs of category 1 in February 2019: queue No up to March 1, 2019 2、 In February, CDE undertook 29 new applications for registration of traditional Chinese medicine, including 1 new drug and 28 supplementary applications Figure 3: CDE acceptance of traditional Chinese medicine in January and February 2019 3 Review of biological products In February, CDE undertook 108 new biological product registration application acceptance numbers, 18 new drugs, 75 supplementary applications and 11 imports Figure 4 acceptance of CDE biological products in January and February 2019 eight class 1 biological products for treatment were accepted this month, and all of them have entered the corresponding queue for approval Table 3 notes to class 1 new drugs of therapeutic biological products newly undertaken in February 2019: the queue number is up to March 1, 2019 4、 Compared with 207 in January, the number of acceptance numbers declared according to the consistency evaluation in this month is also affected by the Spring Festival However, compared with 6 in February 2018, the number of acceptance numbers declared according to the consistency evaluation has greatly improved, reaching a new record, and 73 acceptance numbers declared according to the requirements of the consistency evaluation have been added Figure 5 quantity of acceptance of consistency assessment in January and February 2019 Table 4 data source of acceptance number of new consistency assessment in February 2019: drug intelligence data annex: analysis report of CDE drug review in February 2019 PDF statement: this point of view only represents the author, not the position of drug intelligence network, 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.