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

Highlights: 1 Six new chemical drugs of category 1 (by variety) were added this month 2 This month, new chemical drug registration category 5 registration applications are added 3 Albuvirtide, a long-acting new anti AIDS drug independently developed by frontier biology, has been applied for production and undertaken by the drug examination center According to the latest statistics of drug intelligence database, in July 2016, CDE undertook 261 new drug registration applications with acceptance number (the same below except for reexamination) Figure 1 acceptance of CDE drugs from January to July 2016 In July 2016, the total amount of acceptance continued to be low According to the CDE examination, there are 210 chemical drugs, 21 traditional Chinese medicine, 26 biological products and 4 pharmaceutical excipients Let's analyze the registration, acceptance and evaluation of chemical drugs, traditional Chinese medicine and biological products In July, CDE undertook 210 new chemical registration applications with acceptance number Figure 2 acceptance of CDE chemical drug application types from April to July 2016 in the field of chemical drugs, new drug registration and application declined In this month's chemical declaration, the new registration classification and the old registration classification coexist 1 Application of class 1 and class 1 new drugs: this month, CDE accepted 5 acceptance numbers of class 1.1 chemical drugs and 9 acceptance numbers of class 1 new drugs, involving 8 varieties and 7 enterprises The figure below shows the new class 1.1 and class 1 drugs in July Table I the new chemical 1.1 and class 1 new drug, fg-4592 capsule declared by fabozin (China) Pharmaceutical Technology Development Co., Ltd in July 2016, respectively, obtained CDE on July 11 and 14, 2016 The drug was declared for import in July 2009 In April 2014, Beijing fabojin applied for clinical application for the first time according to category 1.1, and was approved for clinical application in August of the next year Table 2 data sources of relevant clinical trials of Kemei in China: brvanib (BMS-540215), developed by BMS company, is a selective dual inhibitor of vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR) kinase with oral biological activity, which is used to treat advanced liver cancer (China new drug journal, Vol 21, No 17, 2012) in March 2015, Bristol Myers Squibb Company zaiding Pharmaceutical Co., Ltd jointly announced that the two sides had signed an agreement: in the Greater China region, including Hong Kong and Macao, zaiding Pharmaceutical Co., Ltd would have the exclusive right to develop, produce and commercial promotion of brivanib Albuvirtide is a new long-term anti AIDS drug independently developed by leading biology It is the first long-term HIV fusion inhibitor in the world It has obtained patent authorization from China and the United States, and has registered a world patent within the patent priority period (Pharmaceutical progress, Vol 38, No 3, March 2014) In March 2007, Chongqing frontier biology applied for clinical application and obtained approval Led by Beijing You'an Hospital Affiliated to Capital Medical University, it has carried out the largest confirmatory phase III clinical trial in China's AIDS field in 12 clinical centers nationwide, and has achieved encouraging phased results The preliminary results show that the new treatment plan including "ibowetai" drug has good safety and effectiveness If the research and development is successful, it will meet the major clinical needs and improve the current situation of drug shortage in China (2015 12 "National AIDS treatment clinical demand and Innovation Research Symposium" of China AIDS STD) table 3 data source of domestic relevant clinical trials of ibowetai: China clinical trials database of drug intelligence network 2 Application of new version of registered classified drugs 5 categories also increased 2 this month There are five new categories of drug declaration, namely, the application for listing of drugs on overseas market in China, which makes a clear distinction between the original research and the non original research They are divided into 5.1 and 5.2 categories: 5.1 the original research drugs (including APIs and their preparations) on overseas market apply for listing in China; 5.2 the non original research drugs (including APIs and their preparations) on overseas market apply for listing in China Table 4: in July 2016, CDE undertook 21 new applications for registration of traditional Chinese medicine, including 3 new drugs, 15 supplementary applications and 3 import re registration Figure 3 acceptance of CDE traditional Chinese medicine from April to July 2016 In July, CDE undertook 26 applications for registration of new biological products, 7 new drugs, 10 supplementary applications and 9 imports Figure 4 acceptance of CDE biological products from April to July 2016 one acceptance number of class 1 biological products was accepted this month, and now it has entered the clinical trial application sequence to wait for approval Table V new class 1 biological products in July 2016 note: queue No up to August 2, 2016 Tianshili chuangshijie (Tianjin) biopharmaceutical Co., Ltd is a Sino French joint venture established by Tianjin Tianshili Pharmaceutical Co., Ltd and French trangene Co., Ltd in 2010, which is committed to the research and development of biopharmaceutical 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.