CDE drug review weekly report (2015.9.12-2015.9.19)

In the review this week (2015.9.12-2015.9.19), 95 drugs (calculated by acceptance number, the same below) entered the review status, 90 chemicals, almost the same as last week, including 6 1.1 categories, 4 1.3 categories, 36 3.1 categories, 8 3.2 categories, 1 3.3 categories, 1 3.4 categories, 23 6 categories, 10 imports The number of class 3.1 drugs in the queue for review this week increased slightly compared with last week, while the number of class 6 and imports decreased slightly There are also 4 biological products for treatment and 1 biological product for prevention, basically the same as last week This week, the field of drug evaluation and treatment mainly focused on 19 nervous systems, 15 systemic anti infectives, 14 digestive tract and metabolism, and 9 cardiovascular systems In addition, the declaration volume of 3.1 category went up again this week, and the following varieties were examined by small editors, mainly including apopst, wottixitin, englejin, tophatib, etc However, there are a lot of 3.2 types this week, mainly compound antihypertensive drugs This common problem is estimated to have been solved, and we have started to report again In addition, after Beijing Wansheng Pharmaceutical Co., Ltd., Zhengda Tianqing also applied for compound redipavisofibravir tablets, and after Zhengda Tianqing, Jiangsu Hengrui also applied for nindartrogram ammonium bromide inhalation powder spray, feeling that the compound medicine is now a little hot The key points are as follows: 1 Pipcycline: This product is a class 1.1 chemical medicine declared by Henley Pharmaceutical Technology Co., Ltd of North Shandong Province, including the acceptance number of pipcycline raw materials and two capsules Kbp-7072 has been used for multi drug resistant bacterial infection At present, it has been approved by FDA for clinical trials, and one phase I clinical trial is in the recruitment stage It is the first time in China to apply for clinical application and enter the review stage 2 Bpi-3016: This product is the chemical medicine declared by Beida Pharmaceutical Co., Ltd in category 1.1, including the acceptance number of bpi-3016 raw material and one injection This product is a long-acting GLP-1 analogue, which is used for the treatment of type II diabetes It is declared in China for the first time 3 Duotiabalami tablets: This product is an imported chemical declared by GlaxoSmithKline (China) Investment Co., Ltd., and it is the first time that this drug has been declared in China But Xiaobian can't find any information about the drug According to the name, it's supposed to be an anti-virus compound Some known partners can comment on it There is also a wonderful drug this week, namely the new drug l-ornidazole and its tablets, dispersible tablets and capsules declared to be on the market by Hunan Warner Pharmaceutical Co., Ltd in category 1.3 This product entered the review center in March 2011, and completed the three in one review in May 2015, and is undergoing the three in one review However, after that, the National Bureau may say, I don't agree with your review opinions, go back to the review, so now the status has changed back to the review But we can't rule out the problem of CDE system Let's wait and see In the approval week, a total of 25 drugs are in the approval status, 23 chemicals and 2 biological products for prevention Among the chemicals, there are 3 in 1.1, 1 in 1.6, 5 in 3.1, 1 in 3.2, 1 in 3.3 and 6 in 2 The rest are imported The key points are as follows: 1 Shr3680: This product is a 1.1 chemical medicine declared by Jiangsu Hengrui Pharmaceutical Co., Ltd., including the acceptance number of shr3680 raw materials and 2 tablets At present, it is speculated that the product is an androgen receptor inhibitor, and the indication is prostate cancer Undertaken in February 2014, it has been reviewed and approved for clinical application 2 Ertugliflozin · L-PGA: This product is imported and declared by MSD, including the acceptance number of two tablets of ertugliflozin · L-PGA This product is a kind of glucose sodium cotransporter inhibitor, used in the treatment of diabetes, first approved in the domestic clinical See Table 1 for the approved chemicals There are 155 drugs approved this week, more than three times the number of last week, including 152 chemicals, one biological product for prevention and one biological product for treatment Among the chemicals, there are 1 class 1.1, 45 class 3.1, 1 class 3.2, 1 class 3.4, 96 class 6, 8 imported It is worth noting this week that a large number of six generic chemicals have been approved, totaling 96 Except for levofloxacin lactate injection of Lanzhou Dadeli Biochemical Pharmaceutical Co., Ltd., the rest are oral preparations More than 90% of the six approved generic oral chemicals are likely to be filed Among them, there are 16 acceptance numbers of cefdini capsule, 14 acceptance numbers of amlodipine and atorvastatin calcium tablets, 7 acceptance numbers of Acarbose Tablets, 7 acceptance numbers of cefpropene tablets, 6 dry suspensions of cefpropene, 5 acceptance numbers of amlodipine besylate tablets The key points are as follows: 1 Hs-10234: This product is a class 1.1 new drug declared by Jiangsu Haosen pharmaceutical This product is an antiviral nucleoside analogue for antiviral treatment The approved chemical drugs in this period will not be listed one by one Interested friends go to our database, select "approved" for processing status, and select this week for status date You can also select your own date, and you can see all the data The total number of drugs approved this week after the completion of certificate preparation is 67, about 1.5 times of that of last week, all of which are chemical drugs, 51 of which are classified as 3.1, 5 of which are classified as 6, and 11 of which are imported About 20 drugs have been approved this week, most of them are in 3.1 categories, and rofluorostat accounts for half of them The key points are as follows: 1 Losmapimod: GlaxoSmithKline (China) Investment Co., Ltd has declared for import Losmapimod is a p38 mitogen activated protein (map) kinase inhibitor, which plays an important role in the acute inflammation during the heart attack and is mainly used for the treatment of acute coronary syndrome This product was undertaken by CDE in June 2014 and has been approved for clinical use See Table 2 for the drugs after the completion of the preparation Attachment: