CDE drug evaluation: 845 757 chemicals in total

On July 22, the State Food and Drug Administration (CFDA) issued a notice requiring 1622 registrants with acceptance number to carry out self inspection and verification of drug clinical trial data If the authenticity, reliability and integrity of clinical trial data cannot be ensured, the registration application shall be withdrawn independently In July, CDE undertook 757 new chemical registration applications with acceptance number On July 31, CFDA issued a notice again to solicit opinions from the society to solve the backlog problem of drug registration applications, to improve the approval mark of generic drugs, to optimize and change the bioequivalence test review procedures, and to solve the backlog of the same varieties, registration application fraud and other problems CFDA has continuously issued policies and is determined to rectify the drug registration review, but the current effect is not known We will review the drug review in next July before the results of the clinical trial self-examination and consultation are found According to the latest statistics of the database, in July 2015, there were 845 new drug registration applications undertaken by CDE (calculated by acceptance number, the same below), an increase compared with that in June (783), with the growth mainly from chemical drugs Below, respectively, to analyze the application, acceptance, review and approval of chemical medicine, traditional Chinese medicine and biological products 1、 Acceptance of chemical application: in July, CDE undertook 757 new chemical registration applications with acceptance number 1 New drugs (1) 7 new drugs (1.1) 7 new drugs (1.1) applied for clinical database statistics In July, CDE undertook 23 applications for chemical drugs (1.1) with acceptance number, involving 7 varieties, all of which were clinical applications Agratine hydrochloride is a hypoglycemic drug jointly developed by Yabao Pharmaceutical Group and Lilly pharmaceutical, and also the first new drug of 1.1 class declared by Yabao Pharmaceutical Group Agratin can promote the secretion of insulin and reduce the output of glucose in the liver, so as to achieve the effect of hypoglycemic Naridine is a Wnt pathway inhibitor declared by Guangzhou Yuansheng, which is used to treat major tumor and fibrosis diseases The drug belongs to a special review channel and is currently listed in the ind sequence 434 Hutchison Whampoa is a new drug R & D enterprise focusing on the field of inflammation and anti-tumor Since 2009, it has applied for 7 new drugs of category 1.1 The declared hmpl-523 is a selective Syk inhibitor for the treatment of rheumatoid arthritis, multiple sclerosis, lupus erythematosus and other diseases Xinkai's current product line is in the field of kidney disease, metabolic disease and blood disease Xinkai creates the field of anti infection with tenofovir octadecanoxyethyl ester However, tenofovir esters have been on the market for many years, and its 1.1 and 3.1 declaration enterprises have reached more than 10 Guangzhou Nanxin panamivir trihydrate was approved to be listed in the period of bird flu two years ago, which attracted the attention of the industry In July this year, Guangzhou Nanxin Pharmaceutical (a new plant in Nanxin city) applied for a new class 1.1 anti-tumor drug metoclopramide tablet The major shareholder of Nanxin pharmaceutical is Hunan Nonferrous Kaibai biopharmaceutical Co., Ltd in addition, Guangzhou Baiyunshan also holds 13% shares Zhejiang Daoming Pharmaceutical Co., Ltd is a holding subsidiary of Haizheng Pharmaceutical Co., Ltd currently holds two open patents, cn103896946a and cn104059054a Therefore, the dtrmwxhs-12 declared by it may be JAK inhibitor or ALK inhibitor At the end of July, Dalian Dean bioengineering declared a new class 1.1 drug, stg-1 and its injection Before that, Dalian Dean had not declared any medicine The drug is a "11th five year plan major project" co operated by Dalian Dean biology and the school of bioengineering of Dalian University Dalian Dean also holds two related patents of stg-1, with the public numbers of cn1927888b and cn100374462c (2) In July, CDE undertook 228 applications for new chemical drugs in the field of central nervous system Among them, there are 213 clinical applications, involving 83 varieties; 15 listing applications, involving 9 varieties According to the potential variety screening system of the database, we have screened out the varieties for clinical application and marketing of new drugs of category 3.1 for the first time in China, and they may become the first imitations in China in the future Suvorexant (trade name belsomra) is a insomnia drug approved by the FDA by Merck in August 2014 It is the first orexin receptor antagonist approved for the treatment of difficult to fall asleep or maintain sleep Suvorexant has also been rejected by the FDA due to dose and safety issues Dongguan Changan East Sunshine in this drug was approved a year later, ahead of the domestic declaration Safinamide (trade name xadago) is newron's adjuvant treatment drug for Parkinson's disease, which is used in other early and middle late PD patients with ineffective treatment This MAO-B and dopamine reuptake inhibitor was approved for market in the European Union in February 2015 Within six months after the drug was launched, Guizhou Hengshun has submitted its application in China Efinaconazole (trade name jublia) was first developed by Canadian Dow pharmaceutical company and approved by FDA in June 2014 It is used to treat hand, foot and grey nails caused by Trichophyton rubrum and Trichophyton gymnoides which are difficult to cure Cro Nanjing Huawei pharmaceutical first imitated the drug in China The application of valproic acid hemisodium by Peking University Pharmaceutical is mainly used to treat epilepsy and bi-directional affective disorder The clinical approval of the drug was obtained by founder Pharmaceutical Research Institute of Founder group Sodium valproate is developed by Abbott pharmaceutical and has been on the market for more than ten years, but has not entered China, so Founder group is expected to obtain the first approval for listing in China 2 In July, the number of generic drug applications fell CDE undertook 166 new generic drug applications with acceptance number, involving 99 varieties and 101 enterprises (the same group's subsidiaries are not consolidated) According to database statistics, in the past year, the number of new application acceptance numbers of generic drugs per month averaged 172 In July this year, the number of generic applications declined, but the overall trend of repeated generic applications has not weakened 3 For the first time, 7 imported chemicals were applied for clinical application in China In July, CDE undertook a total of 55 new chemical import registration applications with acceptance number, involving 30 varieties Among them, there are 41 clinical applications involving 23 varieties, 14 listing applications involving 8 varieties Among them, 7 varieties have applied for clinical application for the first time in China Chemical approval: Baiji Shenzhou, Jiangsu Hengrui and other enterprises obtained the statistics of approved clinical database of class 1.1 new drugs Five enterprises, Baiji Shenzhou, Guangzhou bebet pharmaceutical, Zhejiang Huahai pharmaceutical, Jiangsu Hengrui and Chengdu Yuandong Pharmaceutical, obtained the clinical approval documents of class 1.1 new drugs of five chemical drugs in July (subject to the status of "certificate preparation completed - approved documents") 2、 In July, CDE undertook 32 new applications of traditional Chinese medicine with acceptance number Among them, there are only 10 new drug applications, 19 supplementary applications and 3 imitation applications 3、 In July, CDE undertook 50 new applications for biological products with acceptance number Among biological products, GlaxoSmithKline's mepirizumab for injection and Takeda's vedolizumab for injection were first declared in China Mepolizumab is a monoclonal antibody against interleukin-5, which will be the second biological product for asthma except Novartis xolair Because the FDA expert committee objected to the use of mepirizumab in 12-17-year-old patients, it has not yet been approved Vedolizumab of Takeda was approved by FDA in May 2014 for the treatment of adult moderate to severe active ulcerative colitis (UC) and Crohn's disease (CD) Vedolizumab is the first drug that can be used for maintenance therapy of UC and CD patients.