Analysis report on CDE drug review in May 2015

On May 27, 2015, the 20-year drug registration fee standard ushered in a significant change, shocking the entire drug circle Let's take a look at the last month before the price rise What did pharmaceutical companies do? According to the latest statistics of drug intelligence registration and acceptance database, in May 2015, CDE undertook 794 new drug registration applications with acceptance number (excluding reexamination, the same below) Figure 1 the total acceptance of CDE drugs from January to may 2015 decreased by 5.1% month on month in May 2015 Figure 2: CDE drug acceptance from January to may 2015, including 694 chemical drugs, 31 traditional Chinese medicine, 46 biological products, 19 pharmaceutical excipients and 1 in vitro diagnostic reagent The number of chemical medicine, traditional Chinese medicine and biological products has decreased Let's analyze the registration, acceptance and evaluation of chemical medicine, traditional Chinese medicine and biological products 1、 In May, CDE undertook 694 new chemical registration applications with acceptance number, down 3.6% month on month Figure 3: the acceptance of CDE chemical drugs in February to may 2015 was reduced by 40 acceptance numbers in May after the acceptance of new chemical drugs reached a high value in April In addition to the decline in the number of new drugs and generic drugs, import, re registration and supplementary applications have increased slightly The following is a detailed analysis of the acceptance of CDE chemicals in May 2015 1 New drug Figure 4: registration and distribution of new chemical drugs in May 2015 the number of new chemical drugs declared in May was 269, accounting for 38.8% of the total number of chemical drugs declared 73.6% of them were new drugs of class 3.1 1.1 new drug was 3.7% 1) There are 10 acceptance numbers of 1.1 new drugs of CDE acceptance chemical drugs of this month, involving 4 varieties The figure below shows the new class 1.1 drugs in May Table 1 the new drug of 1.1 class applied by Guangzhou Shunjian Biomedical Technology Co., Ltd in May 2015 The new drug of 1.1 class applied for the treatment of CML has entered the clinical application stage Nike tinib can overcome the clinical resistance of Gleevec The DINK group of Guangzhou Institute of biology and health, Chinese Academy of Sciences successfully designed and synthesized an effective BCR ABL T315I kinase inhibitor Nike tinib Relevant patent rights have been transferred to Guangzhou Shunjian pharmaceutical company for later development According to statistics, by the end of May 2015, CDE had undertaken 121 TiNi related acceptance numbers In May 2015, the approval of class 1.1 new chemical drugs was completed Table 2 In May 2015, the approval of class 1.1 new chemical drugs was completed The beretinib enteric coated capsule declared by Beijing puruno Biotechnology Co., Ltd is a c-met inhibitor, which is used to treat tumors The specific indications need to wait and see in the later clinical stage Beretinib declared in April 2014 that the raw materials and two specifications of the capsule are special approved varieties, which have not been supplemented in the middle and are approved for clinical use once 2) Class 3.1 new drug Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd applied for class 3.1 anti gastric acid drug vonolazan fumarate and entered the evaluation center on May 5, 2015 Vonoprazan (tak-438) is a new oral anti gastric acid drug jointly launched by Takeda and Otsuka On March 3, 2014, Takeda pharmaceutical submitted a new drug application (NDA) of vonolazan fumarate (tak-438) to the Ministry of labor, health and welfare of Japan (MHLW), which was approved for listing on December 26, 2014 Clinical application was submitted in China in 2012, which was undertaken by CDE on December 22, 2012, and no listing application has been submitted at present Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd applied first, and Jiangsu Haosen Pharmaceutical Co., Ltd applied for the variety, which was also undertaken by CDE on May 15, 2015 2 Figure 5 acceptance of generic drugs from January 2015 to may 2015: the new drug registration charging standard has been implemented since May 27 I wonder whether the acceptance of CDE will be greatly changed after the new drug registration charging standard is formally implemented? In fact, in the announcement of charging standards for registration of drugs and medical devices (No.53 in 2015) A few days ago, the price list was circulated in the circle, including the small editors and the relevant personnel of drug registration When people were still questioning, the General Administration of Drug Supervision issued a notice in a flash, and the enterprise didn't even have a chance to breathe The new drug registration has increased from the original 35000 yuan to the next 624000 yuan This time, the increase in the registration fee is so large that it is stable, accurate and ruthless that a big move has been made to directly attack the pharmaceutical enterprises The drug R & D circle has exploded If the price increase means reducing the review congestion and improving the review speed, it will undoubtedly be a good thing for large pharmaceutical enterprises in the long term, but the announcement does not give relevant plans and measures; for small pharmaceutical enterprises, it is necessary to consider to re formulate the development plan, although the document mentioned that Small and micro enterprises have corresponding preferential policies, but we can only wait to see what the final situation will be 2、 In May, CDE undertook 31 new TCM registration application acceptance numbers There are 2 new drugs and 27 supplementary applications Figure 6 acceptance of CDE traditional Chinese medicine from February to may 2015 3 In May, biological products, CDE undertook 46 new biological product registration application acceptance numbers Figure 7 Acceptance of CDE biological products from February to may 2015 4 FDA new molecular entities and therapeutic biological products on May 27, 2015 Two new diarrhea IBS-D drugs, viberzi (elugadoline) and Xifaxan (rifaximin, rifaximin), from Swiss imitator Actavis and Canadian drugmaker Valeant pharma Recently, both of them have been approved by FDA The launch of these two new products will help alleviate the two important symptoms (diarrhea and abdominal pain) of IBS-D patients, and at the same time solve the huge unmet medical needs in this field Data source: drug intelligence registration and acceptance database