[exclusive] analysis report on CDE drug review in March 2018

Highlights: 1 The total number of drug audit centers accepted this month is 682 (excluding reexamination) 2 This month, 11 class 1 Chemicals submitted new drug clinical trial applications 3 This month, 2 class 1 Chemicals submitted new drug listing applications According to the latest statistics of drug intelligence database, in March 2018, CDE undertook 682 new drug registration applications with acceptance number (excluding reexamination, the same below) Figure 1 in the first quarter of 2018, the total acceptance of CDE drugs this month reached a new high, 19.6% higher than that in January, including 532 chemical drugs, 43 traditional Chinese medicine and 99 biological products Let's analyze the registration, acceptance and evaluation of chemical drugs, traditional Chinese medicine and biological products 1、 Chemical evaluation in March 2018, CDE undertook 532 new chemical registration applications with acceptance number Figure 2 acceptance of CDE chemicals in the first quarter of 2018 from the perspective of chemicals declaration, the number of supplementary applications increased significantly this month, and new drugs, imports and imitations all decreased to varying degrees 1 Application of chemical medicine class 1 new drugs CDE accepted 31 Acceptance numbers of chemical medicine class 1 new drugs this month, involving 12 varieties and 16 enterprises The figure below shows the newly undertaken class 1 new drugs in March Table I notes to newly undertaken new chemical drugs of category 1 in March 2018: 1 The queue number is up to April 8, 2018; 2 "*" is a special approved variety S086 and tablet, a new class 1 drug declared by Shenzhen xinlitai Pharmaceutical Co., Ltd., with the Chinese name of sacubatralisartan sodium tablet Xinlitai has applied for core patent protection for s086 with the patent publication number of cn105963296a Alisartan ester is a new type of AT1 inhibitor for the treatment of hypertension It is a derivative of losartan metabolite ex3174 It is hydrolyzed into exp3174 in human body to achieve the antihypertensive effect This product was listed by Shenzhen xinlitai in 2014, with the trade name of "xinlitan" The s086 declared this time is a compound preparation of salkubaqu and alisartan ester, which is the same kind of drug of lcz696 (Novartis, entresto, Chinese name salkubaqu valsartan sodium tablets) Lcz696 was officially approved by CFDA for listing in July 2017, which is used for adult chronic heart failure patients with reduced ejection fraction, so as to reduce the risk of cardiovascular death and hospitalization of heart failure Zsp1241 is an innovative drug with clear mechanism and independent intellectual property jointly developed by Guangdong Zhongsheng Pharmaceutical Co., Ltd and Wuxi apptec It is mainly used to treat liver cancer, gastric cancer and other malignant tumors Related compounds have applied for domestic patents and international PCT patents The results of preclinical study showed that zsp1241 was effective in vitro and in vivo, and showed significant antitumor effect on various liver cancer, gastric cancer CDX or PDX models Therefore, for example, zsp1241 is approved to be listed after clinical research, which can make up for the deficiency of the existing standard treatment plan for cancer of liver and stomach, and provide a new and effective treatment method for cancer of liver and stomach (source of its listing announcement) yzj-0673 maleate and its tablets, a class 1 Chemical drug declared by Shanghai Haiyan Pharmaceutical Technology Co., Ltd and Jiangsu Haici biopharmaceutical Co., Ltd of Yangtze River Pharmaceutical Group, belong to small molecule oral anti-tumor drug PI3K inhibitor, which has been undertaken by CDE, with acceptance numbers of cxhl1700271, cxhl1700272 and cxhl1700273 Qhrd107 is an oral targeted anticancer drug developed by Changzhou Qianhong Biochemical Pharmaceutical Co., Ltd the first indication of this application is acute myelogenous leukemia, AML) can inhibit the growth of tumor cells by inhibiting the phosphorylation of RNA polymerase Ⅱ at the transcription level Compared with the existing AML drugs, qhrd107 has new structure, new mechanism of action, clear target, better efficacy and safety, and has independent intellectual property rights (Patent No.: zl2009801123665 and zl2013101360033) Ramtazolam mesylate for injection is a short acting GABAA receptor agonist, which is suitable for general anesthesia in selective surgery The rimazolomesulfonates developed by paion AG are currently in phase III clinical trials Hengrui pharmaceutical and Shanghai Hengrui Pharmaceutical Co., Ltd have developed the toluene sulfonate of remazolam through a lot of preliminary screening and research work In 2013, it was approved for clinical application At present, only Hengrui medicine has submitted the listing application of rimazolum toluenesulfonate and its preparations in China In addition, rimazolum toluenesulfonate and its injection developed by humanwell Pharmaceutical Co., Ltd are in clinical trials (from its listing announcement) the application for listing of class I chemical utidelon and injection jointly submitted by Chengdu Huahao Zhongtian Pharmaceutical Co., Ltd and Beijing Huahao Zhongtian Biotechnology Co., Ltd has been undertaken by CDE with acceptance No cxhs1800004 and cxhs1800005 Utidelon (utd1) is a genetically engineered ebomycin analogue and a new class of non Taxus antitubulin polymeric antitumor drugs In the phase I and phase II clinical studies, the therapeutic potential of breast cancer has been shown Table 2 Declaration of imported chemicals of category 1: two imported chemicals of category 1 were undertaken this month Table 4 notes to newly undertaken imported chemical drugs of category 1 in March 2018: 1 The queue number is up to April 8, 2018; 2 "*" is a special approved variety 2、 In March, CDE undertook 43 new applications for registration of traditional Chinese medicine, including 8 new drugs and 33 supplementary applications Fig 3 acceptance of CDE traditional Chinese medicine in the first quarter of 2018 Shandong Academy of Pharmaceutical Sciences submitted two applications for listing of five categories of traditional Chinese medicine new drugs, namely, side Calendula oral ulcer patch and total flavonoids extract of huangshusunflower 3、 Review of biological products in March CDE undertook 99 new biological product registration application acceptance numbers, 47 new drugs, 44 supplementary applications, 3 imports and 5 re imports Fig 4 acceptance of CDE biological products from January to March 2018 IV varieties declared according to consistency evaluation 11 varieties were declared according to the requirements of consistency evaluation this month Table 5 data source of new undertaking consistency evaluation varieties in March 2018: 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.