CDE drug review weekly report (June 28, 2015 to July 4, 2015)

In the review this week (June 28, 2015 to July 4, 2015), 83 drugs (according to the acceptance number) entered the review status, including 78 chemicals, 3 traditional Chinese medicines and 2 biological products for prevention The key points are as follows: 1 Agratine hydrochloride capsule: This product is a new type of hypoglycemic drug developed by Yabao pharmaceutical and Lilly pharmaceutical Compared with the existing hypoglycemic drugs, it has a dual hypoglycemic mechanism: promoting the secretion of insulin and reducing the output of glucose in the liver Even in patients with diabetes who take other oral antidiabetic drugs that do not work, galatine hydrochloride may still play a powerful role in reducing blood sugar At present, the product has been used in phase II clinical trials in the United States 2.SC10914 tablet: This product is a PARP inhibitor developed by Jiangxi Qingfeng Pharmaceutical Co., Ltd PARP inhibitors can enhance the efficacy of radiotherapy, alkylating agent and platinum chemotherapy by inhibiting DNA damage and repair, and promoting apoptosis of tumor cells Currently, the main PARP inhibitors on the market are olapani of AstraZeneca 3 Compound carboglifloxacin metformin hydrochloride tablets: This product is declared by Harbin Zhenbao Pharmaceutical Co., Ltd in category 3.2 It is the only enterprise in China to declare this hypoglycemic compound Compound carboglitazine metformin hydrochloride tablet is a compound preparation of carboglitazine It was developed by Janssen Pharmaceutical and has been approved by EMA and FDA successively In the approval this week, a total of 9 drugs entered the approval process, all of which are chemicals The key points are as follows: 1 Shr4640 tablets: a new drug of class 1.1 developed by Hengrui medicine This product is a URAT1 inhibitor, which is used to treat gout It was declared in March 2014 as a special review variety and was supplemented once in April 2015 At present, it has been reviewed and approved for clinical application See attached Fig 1 for drug information under approval Approval completed: two drugs have been approved this week, all of which are agogliptin benzoate tablets (cxhl1200404, cxhl1200405) of Shandong Luoxin Pharmaceutical Co., Ltd., and the notice of "disapproval" has been seen in the specific progress There are 12 drugs completed this week, including 10 drugs, 1 Traditional Chinese medicine and 1 biological product for treatment Among them, agritaine benzoate and tablets of Jiangsu Zhengda Tianqing Pharmaceutical Co., Ltd., agritaine tablets of Chongqing Laimei Pharmaceutical Co., Ltd and ruiglinene metformin tablets (1mg / 500mg) of Hangzhou zhuyangxin Pharmaceutical Co., Ltd were approved for clinical use In addition, tadalafei suspension of Shanghai Representative Office of Eli Lilly Asia company saw the notice of "disapproval" in the specific progress See attached table 2 for the chemical drugs after the completion of the preparation Attachment: