CDE Drug Evaluation Weekly Report (2015.5.24-2015.5.30)

In the review this week (2015.5.31-2015.6.6), a total of 123 drugs (calculated according to the acceptance number, the same below) have recently entered the review state, including 111 chemicals (7 chemicals, 1 class, 60 drugs, 3 drugs, 5 classes, 33 drugs, 6 classes, 6 imports, 2 imports and re registration), 5 traditional Chinese medicines, 4 biological products for treatment, 1 biological product for prevention, 2 pharmaceutical excipients Sph3127: This product is developed by Shanghai Pharmaceutical Group At present, its target and indications are unknown It belongs to the drug variety to be recommended for priority review in major new drug creation science and technology projects The acceptance numbers for clinical application are cxhl1500492 and cxhl1500495 2 Retagliptin phosphate: a type 1.1 DPP4 inhibitor developed by Jiangsu Hengrui, is an oral hypoglycemic drug At present, the clinical work has been completed, and the listing application has been reviewed by the State Administration The next step is to queue up and hope to be approved The acceptance numbers for listing application are cxhs15000048, cxhs15000049 and cxhs1500050 3 Salvianolic acid A: the Research Institute of Chinese Academy of Medical Sciences has declared that this product was previously declared with traditional Chinese medicine, and the declared preparations were freeze-dried This time, it was declared with 1.2 chemical drugs (new effective monomers and preparations extracted from natural substances or through fermentation), and the application for tablets is really a great improvement Salvianolic acid A has a wide range of pharmacological activities, including antioxidant, myocardial ischemia protection, antithrombotic, neuroprotective, anti fibrosis, prevention and treatment of diabetes and complications The acceptance numbers of clinical application are cxhl1500580 and cxhl1500581 respectively 4 Tovaptan: Jiangsu Hengrui applied for listing for the second time in category 3.1, and for the first time in 2013, but it was killed last month The second application has also been reviewed by the State Administration At present, this product has only one listing in China, and one 3.1 class application production At present, it is in the process of issuance and supplement Who can get the second listing, maybe Let's talk about the indications Tovaptan is used to treat hypervolemic or isovolumic hyponatremia with heart failure, cirrhosis and syndrome of abnormal antidiuretic hormone secretion The acceptance numbers of Hengrui's declared production are cxhs1500063, cxhs1500064 and cxhs1500065 respectively 5 Xigliptin metformin tablets: dongyangguang class 6 applied for this product Before that, Zhengda Tianqing class 3.2 applied for the clinical application of xigliptin metformin sustained-release tablets At present, this product is only imported and listed in China, which is used to treat adult type 2 diabetes As for domestic listing, there is no way to wait in line 6 Nedanib: This product has two indications, idiopathic pulmonary fibrosis and non-small cell lung cancer The original domestic manufacturer, bringer Ingelheim, has been approved for clinical use and is currently undergoing clinical trials The first category 3.1 application is Jiangsu Haosen (ningtidani ethanesulfonate) In March 2015, the National Bureau began to handle the review This week, there were four new ones, namely, Zhengda Tianqing, Sichuan Kelun, Jiangsu Xiansheng and Beijing kanglisheng