CDE drug review weekly report (2016.05.30-2016.06.05)
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Last Update: 2016-05-30
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Source: Internet
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Author: User
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Key points of this week: 1 This week (5.22.5-29), Jiangsu Huatai Chenguang contracted half of the chemical drugs that entered the review: tapentadol hydrochloride raw materials (category 3.1), tapentadol hydrochloride injection (Category 2), and tapentadol hydrochloride tablets (category 3.1) 2 No new drugs of category 1.1 have entered the approval stage this week, and only APIs but no preparations have been approved for category 3.1 chemicals In general, generic drugs are the main force of this week (the specific list is attached), but the number is still small, depressed or depressed; 3 The application for production of influenza virus split vaccine of fol biopharmaceutical has been approved , which is one of the withdrawal list of CFDA self inspection withdrawal Announcement No 109 in 2016 4 After the production application of hengruiruigliptin was withdrawn, it was registered again for phase 1 clinical trial on May 23 It is planned to be carried out in the phase I clinical trial and research room of the first hospital of Jilin University with registration numbers (ctr20160327 and ctr20160328) At present, it has begun to recruit healthy subjects and diabetic patients respectively It has been checked in the small compilation, and in recent two months, regletin has launched many phase I clinical trials in the center, and the clinical trials are carried out again by visual inspection 5 The new "rifampin apatinib drug interaction study" of apatinib of Hengrui is planned to be carried out in Xuhui District Central Hospital of Shanghai city to recruit healthy subjects, but it has not yet started to recruit Apatinib has been put on the market at present In 2016, it mainly launched the national multi center phase IV clinical research and combined drug clinical research; 6 Guangdong yililuoding Pharmaceutical Co., Ltd registered the confirmatory clinical trial of non bustard tablets (40mg) The team leader of this trial is the Third Affiliated Hospital of Zhongshan University 528 subjects with registration number of ctr20160316 are preliminarily planned to be enrolled, but they have not been recruited yet According to Xianda data, the company has not obtained the clinical approval documents of non bustard, which may be purchased from other companies or applied for by other companies 7 Shanghai Heshen registered the clinical study of zuoshubili tablet in the treatment of schizophrenia At present, only one leading unit: Shanghai Mental Health Center is registered, and 300 subjects are planned to be enrolled Zuosurbili has always been used to treat functional dyspepsia This time, compared with risperidone, it has no effect on schizophrenia Attachment: generic drugs entering the approval stage this week
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