CDE drug review weekly report (February 1, 2016 to February 7, 2016)

Point 1: this week, there are 134 drugs (calculated according to the acceptance number, the same below), of which 133 chemicals, most of which have been withdrawn by announcement, including a 1.1 new drug p-toluenesulfonamide injection Only two chemicals have obtained clinical approval: cigliptin tablets of Zhengda Tianqing and exenatide microspheres for injection of Bristol Myers Squibb In addition, there is a class 1 therapeutic biological product: recombinant new vermiculin (yeast) for injection, which has obtained clinical approval In January and February 2016, a total of 4 kagliptin tablets were approved for clinical application (only for domestic application) Jiangsu Haosen ranked first, followed by Sichuan Kelun This week, Yangtze River Pharmaceutical and Zhengda Tianqing won the 3rd and 4th places Looking at this situation, caglejing also needs to be reviewed intensively According to the order of application, the batch and the death depends on the clinical work Is there anything that can be done before the patent expires? Recombinant new vermiculin (yeast) for injection is a new antithrombotic drug, which is a derivative of hirudin and has the characteristics of low bleeding It overcomes the risk of systemic bleeding caused by anticoagulant drugs such as heparin and hirudin This product was undertaken in October 2013 and is a major special product Point 2: 354 drugs have been approved this week, including 307 approved clinical drugs, including 4 approved clinical drugs of category 1.1 and 1 biological products for treatment of category 2 Hcp002 is a class 1.1 chemical medicine declared by Shaanxi Synthetic Pharmaceutical Co., Ltd., which is a broad-spectrum triazole antifungal drug and a prodrug of voriconazole It is mainly used to treat progressive and life-threatening infections in patients with immunodeficiency The preparation is hcp002 for injection, which was approved on December 31, 2015, and has not been approved yet The API has been approved this week and has been approved clinically Al8326 tablet is a class 1.1 chemical medicine declared by Hangzhou edcheng Pharmaceutical Technology Co., Ltd It is a multi-target tyrosine kinase inhibitor, intended for the treatment of acute leukemia, ovarian cancer and other diseases This product was undertaken in December 2014 and is a special approved variety At present, it has been approved and approved clinically Edcheng is a Sino US joint venture innovative drug R & D company, which is dedicated to the research and development of small chemical anti-cancer drugs, especially tyrosine kinase inhibitors This week, the approval of al2846 capsule, a 1.1 chemical declared by the company, was completed Al2846 capsule is a C-methionine tyrosine kinase receptor inhibitor, inhibiting other Flt4, vascular endothelial growth factor receptor, and Ron's tyrosine kinase receptor Al2846 has been proved to have significant activity in human gastric cancer SGC 7901, breast cancer MDA-MB-435, colon cancer Colo205 and renal cell carcinoma 786-o xenogeneic models This product was undertaken in February 2015, and is also a special approved variety It is currently approved for clinical use It bodes well that two class 1.1 chemicals are approved for clinical use This product is also a 1.1 chemical, formerly known as gzd824, which was declared by Guangzhou Shunjian Biomedical Technology Co., Ltd and is mainly used for the treatment of CML Nike tinib is an effective BCR ABL T315I kinase inhibitor According to the research, the therapeutic activity of Nike tinib in patients sensitive to gliclavic is more than 1000 times of that of gliclavic, and it can overcome almost all clinical drug resistance induced by BCR ABL mutation This product was declared in May 2015 It is not only a special approved variety, but also a major special variety It took more than half a year It has been approved and successfully approved for clinical use Point 3: 412 drugs have been established this week, 14 of which are not approved, 320 are approved for clinical use, and 55 are withdrawn Among them, sklb1028 capsule, a class 1.1 drug of Shiyao, and Brozo sodium for injection of Zhengzhou University have been established.