CDE drug review report in August 2014

According to the latest statistics of dingxiangyuan insight – China Pharma data database, in August, the drug review center (CDE) of the State Food and drug administration undertook 768 new drug registration applications (calculated by acceptance number, the same below), which was less than the previous month (800) Among them, the decrease was concentrated on chemical and biological products, and the acceptance of traditional Chinese medicine increased slightly compared with last month Below, respectively, to analyze the application acceptance and approval of chemical medicine, traditional Chinese medicine and biological products I in August, CDE undertook 676 new chemical applications with acceptance number, slightly less than that of last month (690) Among them, the specific data of each application type are as follows: 1 In August, CDE undertook 212 new chemical and new drug applications with acceptance number, which was almost the same as last month Next, let's take a look at the acceptance and approval of new chemical drugs in categories 1.1 and 3.1 (1) class 1.1 new drugs ① application acceptance: in August, there were 6 chemical drugs and class 1.1 new drugs applied for clinical application, most of which were antineoplastic drugs: according to the Insight China Pharma data database of DXY, in August, CDE undertook 12 new chemical applications of class 1.1 new drugs with acceptance number, involving 6 All of them are new drug clinical applications The specific data are as follows: lepvastatin, a wholly owned subsidiary of mega pharmaceutical company, is used for the treatment of vulvovaginal candidiasis (vulvovaginal candidiasis) and partial vulvovaginal administration The anti angiogenic peptide (API and injection) declared by Beijing Institute of cancer prevention and treatment is a small peptide containing 15 amino acids, which can inhibit tumor angiogenesis by inhibiting the growth of vascular endothelial cells FPAT (fibrinopeptide A truncated) was found in the serum of patients with gastric cancer Compared with other endogenous anti angiogenic proteins, FPAT has the advantages of small molecular weight, high activity and easy synthesis Lalotaser (API and injection) declared by Zhendong of Shanxi Province is a semi synthetic taxanes derivative It has been shown that larotaxel can resist the resistance of common taxanes and multiple antitumor drugs The product was commissioned by Shanxi Zhendong Pharmaceutical Co., Ltd to research and develop by Shandong target drug research Co., Ltd for patent information, see cn 102210652a Ct-707 (drug substance and granule) declared by Beijing celestine is a multi kinase (ALK / FAK / PYK 2) inhibitor for the treatment of non-small cell lung cancer C118p (APIs and injections) declared by Nanjing Shenghe Pharmaceutical Co., Ltd is a kind of inhibitor of tubulin polymerization It mainly interferes the mitosis process of tumor vascular endothelial cells, inhibits the aggregation of tubulin, and targets to block and destroy the blood vessels that provide nutrition for tumor, so as to cause tumor death due to lack of oxygen supply and hunger C118p is a derivative of combretastin A4 At present, its similar drugs are being developed by oxigene company in foreign countries for the treatment of ovarian cancer, which is in phase III clinical research stage In China, four companies have already applied and obtained clinical approval documents At present, they are still in clinical trial stage, including Zhejiang Dade Pharmaceutical Co., Ltd., southwest Synthetic Pharmaceutical Co., Ltd., Chengdu Hengji Pharmaceutical Co., Ltd and Shanghai Huali bio Pharmaceutical Co., Ltd The specific indications and other information of olmecxone sodium (API and injection) declared by Xianju, Zhejiang Province are unknown However, from its nomenclature, olmecxone may have some relations with immunomodulators such as imexon and ciamexon, suspected to be immunomodulators and antitumor drugs ② 1.1 approval of new drugs of class 1 The innovative antihypertensive drugs of tetracycline and the antithrombotic drugs of nifedipine and ginkgolide mesylate B tablets obtained clinical approval: tylerdipine, a calcium ion antagonist with new chemical structure and independent intellectual property rights developed by tetracycline, is an innovative antihypertensive drug In March 2013, Shandong xuanzhu (the subsidiary of Sihuan pharmaceutical) applied for clinical application (APIs and tablets), and obtained clinical approval in August this year Ginkgolide B (Ginkgolide B) is a six ring cage diterpenoid compound extracted from Ginkgo biloba leaves It is the most powerful platelet activating factor (PAF) antagonist, which is mainly used in the treatment of thrombus and ischemic cerebrovascular diseases In addition, with regard to Ginkgolides, two domestic enterprises have been listed, namely Chengdu Baiyu, which obtained the production approval in October 2011, and Jiangsu Kangyuan, which obtained the production approval in November 2012 (2) class 3.1 new drugs: according to the statistics of Insight China Pharma data database of DXY, in August, CDE undertook 160 new chemical medicine class 3.1 new drug applications with acceptance number Among them, there are 141 clinical trial applications, involving 56 varieties; only 19 listing applications, involving 17 varieties Clinical application: Jiangsu Hengrui's adenosine like and Jiangsu Haosen's aitebante are the first applications in China: in the new application of chemical medicine 3.1 undertaken by CDE in August, Jiangsu Hengrui's adenosine like (API and injection) and Jiangsu Haosen's aitebante acetate (API and injection) are the first applications in China, both of which are clinical applications The specific data are as follows: listing application: of the 17 chemical 3.1 new drug varieties declared for listing in August, only lesagilan is not listed in China at present Rasagiline is the second generation of monoamine oxidase inhibitor, which can block the decomposition of neurotransmitter dopamine and be used to treat Parkinson's disease Developed jointly by Teva and lundbeck, the drug was launched in Israel and Europe in 2005 under the trade name aziect and has since been marketed in several countries around the world In May 2010, Lingbei declared the import clinical application of lesagilan mesylate in China In July 2011, Lingbei obtained the clinical approval document In January this year, Lingbei applied for listing At present, it is waiting in line for review The serial number of NDA (application for new drug listing) is 266, 267 According to the review rhythm of CDE, it will be at least until next year Among the domestic manufacturers, 12 enterprises have applied for the product, among which three have applied for listing (Changzhou No.4 pharmaceutical, Shanghai Zhongxi pharmaceutical, Qilu) Among them, Changzhou No.4 Pharmaceutical Co., Ltd was the first one to declare its new drug clinical application of lesagilan mesylate (API and tablet) in February 2006 It obtained the clinical approval document in June 2007, and first declared for listing in September 2012 In June this year, it left the task sequence of the new report and received a notice from CDE The content of the notice is not clear 2 In August, CDE undertook 184 new applications for generic drugs with acceptance number, involving 95 varieties These generic drugs are mainly concentrated in the treatment fields of digestive tract and metabolism, anti infection, blood and hematopoietic organ drugs, cardiovascular system drugs, etc 3 Import: according to the statistics of insight - China Pharma data database of DXY, in August, CDE undertook 25 new chemical import applications with acceptance number, involving 22 varieties Among them, there are 13 clinical application varieties and 9 listing application varieties Import clinical application: pt003 (formoterol / glulammonium bromide) is the first clinical application in China: pt003 declared by Pearl Company (acquired by AstraZeneca) is a fixed dose combination of long-acting β - 2 agonist formoterol fumarate and long-acting muscarinic receptor antagonist glulammonium bromide, which is used for the treatment of moderate to severe chronic obstructive pulmonary disease At present, it is in Ⅲ abroad Stage of clinical experiment Import listing application: Pfizer's axitinib is the first domestic listing application: axitinib (trade name: inlyta), which was approved by the U.S FDA in January 2012 for the treatment of advanced renal cancer, and then has been listed in Japan, Canada and other countries Pfizer applied for clinical import in November 2006, obtained clinical approval in September 2007 and went public in August this year As for acitinib, Sichuan Kelun, Qilu pharmaceutical, Jiangsu Haosen and Hefei Tuorui have applied for clinical application successively among domestic manufacturers, and they are all in line for review 2 In August, CDE undertook a total of 53 new applications for traditional Chinese medicine, including 16 new drug applications and 37 supplementary applications 3 Biological products according to the latest statistics of insight - China Pharma data database of dingxiangyuan, in August, CDE undertook 28 new applications for biological products with acceptance number, including 7 new drug applications There are two kinds of new drugs of class 1, all of which are clinical applications They are pegylated recombinant human insulin injection of Chongqing Fucheng biological Co., Ltd and exendin-4 Fc fusion protein injection of Beijing dongfangbaitai biological Co., Ltd There are two varieties of biological products for import application, which are also clinical applications They are respectively situximab for injection declared by Janssen, a subsidiary of Johnson & Johnson, and simetide injection declared by Novo Nordisk Situximab (trade name: sylvant), an anti IL-6 chimeric monoclonal antibody, was approved by the FDA in April this year and the European Drug Administration (EMA) in May It is used for HIV and HHV- 8) The treatment of patients with multicentric Castleman's disease (MCD) is the first approved drug for the treatment of MCD Semaglutide is a GLP-1 analogue developed by Novo Nordisk for the treatment of type 2 diabetes mellitus At present, it is in phase III clinical research abroad