CDE drug review weekly report (August 24, 2015 to August 29, 2015)

I during the review this week (August 24, 2015 to August 29, 2015), 57 drugs (calculated according to the acceptance number) entered the review status, 54 chemicals, and the quantity returned, 1 / 3 more than last week There are 13 3.1, 1 3.2, 2 3.4, 2 5, 22 6 and 11 imported chemicals In addition, there are 1 biological product for treatment and 2 biological products for prevention This week, the number of 3.1 drugs is similar to that of last week There is no first application for 3.1 drugs If this amount continues, it will still be lower than before This week's six categories of drugs were almost the same as last week, and the policy seems to have little impact on generic drugs This week, Bayer medicine has three drugs in the review status, namely finerenone film coated tablets, copanlisib injection lyophilized preparation and odm-201 300mg film coated tablets Finerenone film coated tablets are applied for the first time this month with acceptance numbers of jxhl1500212 and jxhl1500213, respectively This product is a new generation of oral and non steroidal corticosteroid receptor (MR) antagonists, which can block the harmful effects of aldosterone Currently available MR antagonists have been proved to be effective in reducing cardiovascular mortality in patients with heart failure, but serious side effects limit the use of these drugs Finerenone is currently in phase IIB clinical development for the treatment of worsening chronic heart failure and diabetic nephropathy Copanlisib lyophilized preparation for injection was first declared at the end of 2014 At present, there are four acceptance numbers in China, all of which are in line This product is a novel oral phosphoinositide 3-kinase inhibitor, which shows a wide range of antitumor activity in preclinical tumor models At present, phase III research in non-Hodgkin's lymphoma patients is in progress Odm-201300mg film coated tablets were first declared at the end of 2014 At present, there are two acceptance numbers in China, all of which are in line This product is a new generation of androgen receptor antagonists, it is different from other antiandrogen drugs, it does not enter the brain in non clinical models It can inhibit androgen receptor by blocking nuclear heterotopia Odm-201 has no activation effect on androgen overexpression At present, phase III research is in progress in patients with non metastatic castration resistance to prostate cancer 2 In the approval week, 8 drugs are in the approval status, 5 chemicals, 2 biological products for prevention and 1 biological products for treatment The key points are as follows: 1 Asc08: This product is developed by Geli biology, and its chemical name is danoprevir It is a direct anti HCV drug Previously, the data of phase II clinical trial was released in the form of special theme report by the president of the conference at the 24th Annual Meeting of Asia Pacific Society of Hepatology on March 13, 2015 According to the results of the second phase clinical study named dapsang, after 12 weeks of treatment, the cure rate (svr12) of patients with genotype 1 non cirrhosis in Taiwan was 94%, while that of patients with genotype 1b non cirrhosis was 100% This product entered the CDE evaluation center in April 2014 It is a special approved product and has not been supplemented It is currently approved for clinical use See Schedule 1 for the drugs under approval 3 There are 5 drugs, 4 chemicals and 1 biological product for prevention approved this week Among them, ibuprofen injection of Nankai Yugong Pharmaceutical Co., Ltd and difluorocolon valerate cream of Tianjin Pharmaceutical Research Institute Co., Ltd were approved for clinical use One biological product is GlaxoSmithKline's live attenuated human rotavirus vaccine IV there are 9 drugs approved this week after the completion of certificate preparation, all of which are chemicals, including 4 drugs of category 3.1, 3 drugs of category 6, and 2 drugs imported Among them, the lakolamide tablets of Shaanxi step Pharmaceutical Co., Ltd and the rofluorast tablets of Jiangxi Qingfeng Pharmaceutical Co., Ltd were approved for clinical use See attached table 2 for the drugs that have been prepared Attachment: