CDE drug review weekly report (2016.05.23-2016.05.29)

Abstract: there are only a few drugs entering the CDE review center this week, only one class 1.1 drug However, the review of a large number of drugs has been completed, including 267 drugs under review, 86 drugs under review and 469 drugs under certification Please refer to the text for key drugs This week's highlights 1 Hubei biomedical industry technology research institute and Wuhan kemeide biomedical Co., Ltd jointly applied for class 1.1 wxfl10040340 API and its capsules, with a total of 3 acceptance numbers; 2 Class 1.3 new drugs of Hunan Warner Pharmaceutical Co., Ltd levononidazole dispersible tablets and levononidazole capsules After the review of production application, it has been approved During the clinical verification, it is not clear whether it is actually produced or not; 3 The review of anilofen eye drops, a new class 1.1 drug of Guangdong Zhongke Pharmaceutical Research Co., Ltd.; 4 The review of clinical application of recombinant anti-CD20 mouse chimeric monoclonal antibody injection of Shandong new era rituximab; 5 The review of Novo Nordisk The clinical application review of degulin / lilalutide injection compound preparation was completed; 6 The import clinical application review of Bayer non steroidal corticosteroid receptor (MR) antagonist finerenone film coated tablets was completed 7 Only Lansoprazole for injection (Fengyuan), agatraban injection (Fengyuan), montelukast sodium tablets (Kunming Yuanrui), sagletin tablets (Hebei Tiancheng), atorvastatin calcium tablets (Henan Runhong) and nifurtel vaginal tablets (Hunan Jiudian) were used in CDE this week; 8 267 of them were approved this week (according to the acceptance number, the same below) almost all of the drugs are chemical drugs, among which the most involved acceptance numbers are: xigliptin phosphate tablets (8), rosuvastatin calcium tablets (8) and L-amlodipine besylate tablets (7) 9 This week 469 pharmaceutical certificates were completed, including 450 chemicals: 1.1 of the following categories: the division of pevagin gel, the repaglinide phosphate (production application), the ASC16 tablet, the itafenib tablet, the HMPL-523 acetate tablet and the DTRMWXHS-12 capsule Introduction to key drugs wxfl10040340 capsule This product is jointly developed by Hubei biomedical industry technology research institute and Wuhan kemailide biomedical Co., Ltd recently Hubei biomedical industry has entered CDE strongly Last week, there was a 1.1 type of CDE, namely the BTK inhibitor wxfl10230486 capsule developed in cooperation with humanwell pharmaceutical According to the pepline of Hubei biomedical industry, this week's capsule should be a PARP inhibitor Preparation for the treatment of malignant solid tumors Levornidazole dispersible tablets and levornidazole capsules: these two drugs are all declared by Hunan Warner Pharmaceutical Co., Ltd., with acceptance numbers of cxhs1000303 and cxhs1000304, both of which are of 1.3 categories The triad review has been completed and the triad review is in progress According to the previous, this batch production has been completed properly, but since the clinical verification was published, the batch production is always confusing L-ornidazole, the L-isomer of ornidazole, is mainly used for anaerobic infection At present, only one company in China has listed l-ornidazole sodium chloride injection Anilofen eye drops: a new class 1.1 drug developed by Guangdong Zhongke Pharmaceutical Research Co., Ltd is under the charge of preclinical research by the Pharmaceutical Department of Zhongshan Eye Center, Sun Yat sen University Anilofen is a non steroidal anti-inflammatory drug In 2010, Guangdong Zhongke Pharmaceutical Co., Ltd and Dalian Tianyu Co., Ltd obtained the clinical approval document of this product injection, but it has not been applied for production so far This week, the clinical application of anilofen eye drops has also been reviewed Recombinant anti-CD20 mouse chimeric monoclonal antibody injection: This product is a biological imitation of rituximab Shanghai CITIC Guojian is the first to obtain clinical approval in China After applying for production, CITIC Guojian is still in line Since then, Shenzhou cell engineering, Zhejiang Haizheng, Shanghai Fuhong Hanlin, Xinda biology and Shenzhen Wanle have obtained clinical approval This week, the review of this product in the new era was completed, and a supplement was issued in July 2015 It is speculated that this product has also been approved for clinical use Finerenone film coated tablet: This product is a kind of non steroidal corticosteroid receptor (MR) antagonist When it was first applied for clinical application in China, it was introduced in the review weekly report of phase 51 It belongs to a special review variety and has been reviewed for 9 months At present, the product has been in phase III clinical practice in the United States The main indications are chronic heart failure, diabetic nephropathy, etc.