CDE drug review weekly report (2016.06.27-2016.07.03)

This week, Otsuka applied for brexpiprazole tablet in China for the first time What is the change from approval to review of Kanghong Compaq CEPP production application? The clinical application of goserellin acetate sustained-release microspheres for injection into Shandong green leaves was reviewed More Beida pharmaceutical ektinib hydrochloride cream for clinical use Highlights of this week: 1 The number of drugs entering the review process continued to decrease this week, with only 18 drugs and no 1.1 chemicals See Table 1 for details It is worth mentioning that Otsuka pharmaceutical applied for the clinical application of brexpiprazole tablet (epiprazole tablet) in China for the first time Brexpiprazole is a new type of mental disease drug jointly developed by Otsuka pharmaceutical of Japan and Lingbei of Denmark, which was approved by FDA for listing in July 2015 At present, only kanglisheng family has declared this product in November 2015 In addition, the listing application of Kanghong Kangbai Xipu ophthalmic injection changed from the approval status two weeks ago to the review status I don't know why It is understood that this product has been listed This application is to add new indications, i.e for the treatment of choroidal neovascularization secondary to pathological myopia Since August 2015, it has entered the review process It is a major special variety, which has been in the approval state recently I don't know why it has changed back to the review state Is CDE bug again? 2 The production application of cefotaxime sodium and tazobactam sodium (6:1) for injection in Nanjing Youke has been reviewed and is in the approval status This product is a new compound preparation of Class 1.5 According to the investigation, the clinical approval document should be purchased by Nanjing Youke from Nanjing Xinye Pharmaceutical Technology Co., Ltd (obtained in 2005) It was declared for production in April 2012 This product is a product in the announcement of the on-site verification plan for clinical trial data (No 2) 80% of it has also been withdrawn, and the batch production is hopeless 3 The clinical application of goserellin acetate sustained-release microspheres for green leaf injection in Shandong Province has been reviewed This product is a class 2 new drug and entered the review center in January 2015 In addition, this product has been approved by FDA in March this year for clinical trials of prostate cancer treatment The product code is ly01005, self-developed by green leaf pharmaceutical, injected once a month, registered in the United States through 505 (b) (2) Compared with the products on the market, ly01005 has similar bioavailability, but has better patient compliance and more stable efficacy The product has been patented in the United States, Europe, Japan and other countries This is the first long-term preparation registered in the United States for clinical research and cancer treatment In addition to the United States and other countries, LVYE also plans to apply for the clinical research of ly01005 in China, Europe, Japan and other countries; in addition to ly01005, LVYE currently has a number of products in different clinical stages in the United States, including risperidone sustained-release microspheres for injection (ly03004), ansufaxine hydrochloride sustained-release tablets (ly03005) and rotigotine sustained-release microspheres for injection (ly03003) 4 The production application of orotadine hydrochloride for class 3.1 new drug of Liaoning Ketai bio gene Pharmaceutical Co., Ltd has been reviewed This product is also the product in the announcement of the on-site verification plan for clinical trial data (No 5 This week, the clinical trial of beta pharmaceutical's exetinib hydrochloride cream was started The product obtained the clinical approval document in March 2016 and is a new class 2 drug This week, the phase I clinical trial was registered in CDE drug clinical trial registration and information publicity platform The indication was mild to moderate psoriasis The main purpose was to observe the safety and tolerance of different concentrations of exetinib hydrochloride cream in the treatment of mild to moderate psoriasis It provides the basis for the determination of the recommended dose and administration plan in the later clinical research There were no healthy subjects in the group It has passed the human body research ethics committee of the Second Affiliated Hospital of Zhejiang University Medical College on May 30, 2016, and is planned to be carried out in the center 6 Jiangsu Weikeli pharmaceutical science and Technology Co., Ltd and China Pharmaceutical University cooperated to carry out the second phase I clinical trial of 1.1 new drug vicagel tablets The first phase I clinical trial was registered in May 2015 and carried out in Zhongshan Hospital Affiliated to Fudan University It was completed in December 2015 to evaluate the tolerance and safety of single oral administration of vecargyle tablets and the pharmacokinetic (PK) characteristics of vecargyle tablets in healthy adult subjects The second phase I clinical trial was registered to evaluate the effect of food on the pharmacokinetics of vicargyle tablets It was still carried out in Zhongshan Hospital Affiliated to Fudan University, and 24 healthy subjects were planned to be enrolled, According to the test information, the product has three specifications: 2.5mg, 10mg and 25mg The indications are to prevent and treat the circulatory disorders of heart, brain and other arteries caused by the high platelet aggregation