CDE drug review weekly report (June 7, 2015 to June 13, 2015)

1 In the review week (2015.6.7-2015.6.13), there are 90 drugs in the review status (calculated according to the acceptance number, excluding supplementary application and review), including 84 chemicals, 6 traditional Chinese medicine, and no biological product application 1 Fns007: fns007 raw materials and injections are class 1.1 drugs exclusively developed by Hebei FeNiS Biotechnology Co., Ltd., which are small molecular polypeptide drugs for the treatment of rheumatoid arthritis The target is HLA-DR molecule By blocking the formation of "HLA pathogenic antigen TCR" three molecule complex, it can inhibit the activation of patients' own reactive T cells, which belongs to antigen-specific treatment and is expected to be solved To solve the problems of safety and remission rate of existing drugs 2 Lovatinib: developed by Weicai pharmaceutical, this product is a multi-target RTKs inhibitor, including vegf1, vegf2, vegf3, as well as a variety of FGFR, PDGFR α, kit and ret In February 2015, it was approved by FDA priority review channel for the treatment of patients with local recurrence or metastasis, refractory radioiodine, and progressive differentiated thyroid cancer (DTC) At present, in addition to the clinical application of the original research materials, Hengrui medicine is the first one in China, which is also fast enough 3 Lyoxigua: This product was approved by FDA for marketing in October 2013 and used for the treatment of pulmonary hypertension It is mainly aimed at chronic thromboembolic pulmonary hypertension At present, the original research institute has carried out clinical trials in China Dongyangguang, the first enterprise in China, declared last month, followed by Nanjing Huawei 2 There are 89 drugs in the approval status this week, including 81 chemical drugs, 3 traditional Chinese medicine, 3 biological products for treatment and 2 biological products for prevention 1 Omeprazole aspirin enteric coated capsule: This product is a new compound preparation, which is used to prevent the risk of gastric ulcer in cardiovascular disease patients taking aspirin At present, there is only one application from South Korea and the United States in China, which has been approved for clinical application 2 Agliptin benzoate: This product is a DPP4 inhibitor developed by Takeda It is an oral hypoglycemic drug It was approved by FDA in January 2013, and approved for marketing in China in July of the same year At present, only the approved Zhengda Tianqing and Hefei cube pharmaceutical are domestic enterprises that have obtained class 3.1 clinical approval 3 Metoprolol s-succinate: This product is a single isomer of metoprolol, which was first listed in India Theoretically, this product has lower side effects on respiratory tract compared with metoprolol racemates currently listed in China There is only one application for Shandong new era in China, which has been approved for clinical application See attached table 1 for other drug information There are 93 drugs approved this week, including 66 chemical drugs, 22 traditional Chinese medicine, 2 biological products for treatment and 3 biological products for prevention Remazolam benzenesulfonate: This product is a kind of narcotic drug Hengrui first applied for category 1.1, but it is toluene sulfonate Yichang humanwell applied for benzene sulfonate, guessing to evade patent Cefepime axetil: This product is the third generation of oral cephalosporins At present, only hausen pharmaceutical is on the market in China Cephalosporin pivoxil tablets of Shiyao group are major special varieties At present, the three in one review has been completed and is under review It is estimated that they will be on the market soon Guipaizite maleate: This product was initially marketed exclusively by Beijing 4th Ring Road, and guipaizite injection from Jinshan, Fujian Province was launched in March this year This week, guipeizite of Qilu pharmaceutical was approved It was declared in 2010 and supplemented once in 2012 At present, the conclusion is unknown See attached table 1 for other application information There are 36 drugs completed this week, including 35 chemicals and 1 biological product for treatment The clinical approval documents have been obtained for ipratron tablets of Hefei Xinfeng science and Technology Development Co., Ltd and China Pharmaceutical Research and Development Center Co., Ltd., bunanselin tablets of Tianjin Central Pharmaceutical Co., Ltd and sitafloxacin tablets of Shandong Qidu Pharmaceutical Co., Ltd See attached table 2 for details