Analysis report of CDE drug review in May 2016 - drug intelligence registration and acceptance database

Highlights: 1 On May 27, 2016, the General Administration issued a notice on 15 enterprises withdrawing 22 drug registration applications 2 Nine new chemical drugs of category 1.1 (by variety) were added this month According to the latest statistics of drug intelligence database, in May 2016, CDE undertook 286 new drug registration applications with acceptance number (excluding reexamination, the same below) Figure 1 the acceptance of CDE drugs from January to may 2016 In May 2016, the total acceptance reached a "low period", which was continuously reduced compared with April According to the CDE examination, there are 231 chemical drugs, 17 traditional Chinese medicine, 29 biological products and 9 pharmaceutical excipients Let's analyze the registration, acceptance and evaluation of chemical drugs, traditional Chinese medicine and biological products In May, CDE undertook 231 new chemical registration applications with acceptance number Figure II Acceptance of various application types of CDE chemicals from January to may 2016 on the whole, compared with April, the registration and application of new drugs and generic drugs continued to decline, especially the original 3.1 new drugs decreased sharply, only 28 acceptance numbers 1 At the same time that all indicators of the application of new drugs of category 1 are reduced by a small margin, new drugs of category 1 are developing steadily This month, CDE accepted chemical drugs of category 1.1 with a total of 27 acceptance numbers, involving 9 varieties and 8 enterprises The figure below shows the new class 1.1 drugs in May Table 1: in May 2016, Hubei Biomedical Industry Technology Research Institute Co., Ltd., a new class 1.1 chemical drug, entered the drug examination center Wxfl10230486 API and capsule (0.5mg / 5mg) are jointly applied by humanwell Pharmaceutical Group Co., Ltd (securities code: 600079) and Hubei Biomedical Industry Technology Research Institute Co., Ltd (a wholly-owned subsidiary of Wuhan Guanggu humanwell biomedical Co., Ltd.) It is understood that wxfl10230486 is a Btk inhibitor, which can be used in the clinical treatment of rheumatoid arthritis The drug has a novel compound structure and has completed pre clinical research The company has submitted related compound Chinese patent applications (201410251204.2, 201510018849.6) and compound PCT international patent applications (PCT / cn2014 / 080887, PCT / cn2015 / 081686) Btk inhibitor is a new chemical 1.1 drug There is no similar drug with the structure of BTK inhibitor in clinical or on the market at home and abroad Another class 1.1 new drug is wxfl10040340 and capsule, which is jointly declared by Hubei Biomedical Industry Technology Research Institute Co., Ltd and Wuhan kemelide biomedical Co., Ltd 2 others - clinical self examination on May 27, 2016, the General Administration issued a notice on 15 enterprises withdrawing 22 drug registration applications After the announcement on self inspection and verification of drug clinical trial data (Announcement No 117, 2015 of the State Food and Drug Administration) was issued on July 22, 2015, the State Food and drug administration has received 256 new drug registration applications that have completed the clinical trial application for production or import (as of April 1, 2016, the drug registration applicant has voluntarily withdrawn one of the 75 registration applications), a total of 1878 registration applications (calculated by acceptance number) entered the clinical self-examination list As of June 1, 2016, the results of clinical self-examination are as follows Table 2 on site verification results of clinical trial data in May, CDE undertook a total of 17 new TCM registration application acceptance numbers, including 2 new drugs, all of which were 6 categories and 13 supplementary applications Figure 3 acceptance of CDE traditional Chinese medicine from January to may 2016 In May, CDE undertook 29 applications for registration of new biological products, 11 new drugs, 12 supplementary applications and 2 imports Figure 4 acceptance of CDE biological products from January to may 2016 three acceptance numbers of class 1 biological products were accepted this month, including three biological products for treatment, involving three enterprises, which have entered the clinical trial application sequence and are waiting for approval Table 3 new class 1 drugs of biological products newly undertaken in May 2016 note: queue No up to June 1, 2016 The class 1 preventive biological products declared by Wuhan bowo Biotechnology Co., Ltd have also been undertaken by the drug Audit Center, and have now entered the clinical trial application sequence to wait for audit Wuhan bowo Biotechnology Co., Ltd is a holding subsidiary of Renfu Pharmaceutical Group Co., Ltd According to the announcement of humanwell Pharmaceutical Group, oral rotavirus vaccine for infants can stimulate the body to produce immunity against rotavirus, which is used to prevent diarrhea of infants caused by rotavirus According to the domestic database of yaozhi.com, at present, the oral rotavirus live vaccine of Lanzhou Institute of Biological Products Co., Ltd., a domestic enterprise, has obtained the production approval In 2014, the number of rotavirus vaccines issued in batches was about 7.6 million According to the annual immunization program of one dose, the number of rotavirus vaccines issued in batches could only cover about 22% of the newborns in the country Based on the ex factory price of 95 yuan for a single vaccine, the annual sales volume was about 730 million yuan (information source: website of State Food and Drug Administration and relevant documents published by CFDA) Data source: drug intelligence registration and acceptance database note: the intellectual property rights of the above articles are owned by drug intelligence If you need to reprint, please indicate the source and the link of this article.