CDE drug review weekly report (June 6, 2016 to June 12, 2016)

The first domestic application of Nanjing Warwick for togglitazine tablets entered the evaluation stage, and the evaluation of Hengrui shr-1314 injection and jiaochen biological recombinant human interleukin-1 receptor antagonists were completed In addition, furetinib succinate capsule was used clinically This issue focuses on 1 This week, 24 drugs (counted by acceptance number, the same below) entered the review process, only 3.1 and 6 categories, and 3 3 3.1 categories of Nanjing Huawei (2 in 2016 and 1 in 2015), occupying the champion position, among which togreen is the first one to declare in China, see the final schedule for specific varieties; 2 Shr-1314 injection, a class 1 biological product of Hengrui in the treatment of immune system diseases, has been reviewed with acceptance number of cxsl1400084; 3 The evaluation of recombinant human interleukin-1 receptor antagonist for injection, a class 1 biological product of jiaochen in the treatment of rheumatoid arthritis, with acceptance number of cxsl1300115, is a major special product; 4 95 drugs are under approval this week, including 88 chemicals, 5 biological products and 2 traditional Chinese medicines, of which 3.1 categories account for the majority, while 6 generic drugs only have 5; 5 82 drugs have been approved this week Ninofloxacin malate capsule (class 1.1), l-ornidazole dispersible tablet (class 1.3), l-ornidazole capsule (class 1.3), dasatinib tablet (class 3.1), and tovaptan tablet (class 3.1) are all production applications At present, it seems that they should be withdrawn completely, I don't know if they will make a clinical bed again; 6 135 drugs have been certified this week There are still many kinds of traditional Chinese medicine, including 5 kinds and 1 kind of traditional Chinese medicine: salvianolic acid A for injection, Vitexin and Vitexin for injection, sodium Danshensu and their injection; 7 This week, furetinib succinate capsule was registered in CDE clinical trial registration and information publicity platform for the first time, with registration number of ctr20160340 There are three sponsors: Chongqing fuchuang Pharmaceutical Research Co., Ltd., Shanghai Institute of pharmaceutical research, Chinese Academy of Sciences and Jiangsu Wanbang Biochemical Pharmaceutical Co., Ltd There were 196 patients who were registered as positive for anaplastic lymphoma kinase (ALK), but no healthy subjects There are two objectives: phase I: the safety and tolerance of the application of succinic acid in the patients with ALK positive advanced solid tumors; to determine the recommended dose of phase II clinical trials; phase II: the safety, tolerance and efficacy of the application of succinic acid in the patients with ALK positive advanced non-small cell lung cancer On May 12, 2016, through the medical ethics committee of Guangdong General Hospital, in addition to the current participating institutions of this hospital, there are Hunan Cancer Hospital, which has not yet been recruited Key drug tofogliflozin: This product is a type 2 diabetes drug approved by PMDA of Japan on March 24, 2014 The drug is jointly developed by sinopharma, Sanofi and Xinghe Sanofi and Xinghe are sold under the trade names of deberza, apleway, respectively Deberza ® is approved for the treatment of type 2 diabetes mellitus It is an oral tablet with the specification of 20mg The recommended dosage is once a day, one tablet at a time At present, this product has not been approved by FDA, and there is no import declaration in China Nanjing Huawei is the first manufacturer of class 3.1 imitation of this product in China I don't know what the prospect is.