CDE Drug Evaluation Weekly Report (2015.5.24-2015.5.30)

1 In the review of this week (2015.5.24-2015.5.30), 45 new drugs (calculated by acceptance number, excluding reexamination and supplementary application, the same below), including 1 Traditional Chinese medicine and 1 biological product Eprazole: This product is a new drug of class 1.1 obtained by Lizhu Pharmaceutical Co., Ltd from Yiyang, South Korea It was first launched in 2008 and is one of Lizhu's main products Eprazole is a PPI drug, which is used to treat gastric and duodenal ulcer and other related diseases It has been sold exclusively in China, and only tablets are on the market at present The injection of Lizhu pharmaceutical is also in clinical practice Now, Jiangsu aosaikang, a big producer of PPI drugs, has finally made a bid to apply for iprazole sodium and its injection, and also wants to take a share 2 Fenofibrate choline sustained release tablets: This product is a kind of lipid lowering drug, a replacement product of fenofibrate, which has been declared by domestic enterprises in category 3.1 Shenyang Huatai has declared new indications in category 1.6, which are not available at home and abroad It is speculated that it is related to lipid lowering, and the specific needs to be known before clinical or marketing 3 Nilotinib: This product is the second-line drug for chronic myeloid leukemia Novartis has been imported and listed in China as early as 2009, but it has not been declared by enterprises for some reason Jiangsu Haosen submitted the API of nilotinib hydrochloride on 3.1 this week, which is the first imitation declaration in China 2 In the approval of this week, a total of 8 drugs entered the approval process, all of which are chemicals: 1 Meperidine hydrochloride: This product is used to treat attention deficit hyperactivity disorder, which is the most common mental illness of children and adolescents At present, only Henan Zhongshuai pharmaceutical science and Technology Development Co., Ltd has applied for two dosage forms: sustained-release capsules and tablets The sustained-release capsules have obtained clinical approval, and the tablets have also been reviewed Now it is in the approval stage, and it is expected to obtain clinical approval 3 After approval, there are 5 approved drugs, 4 chemical drugs and 1 Traditional Chinese medicine in this week, focusing on the introduction of a Haizheng class 1.1 new drug: 1 Ad-35: This product is a new anti Alzheimer's disease (i.e treatment of Alzheimer's disease) drug The application for ind in the United States has been approved At present, Haizheng pharmaceutical has applied for this product in category 1.1 in China The API has been approved and the preparation is still in the review stage However, from the perspective of progress, it has been reviewed This product was declared in October 2013 as a special approved variety It was supplemented once in July 2014 and has been approved for clinical use In addition, the approved chemicals include guanfacine hydrochloride sustained-release tablets, a new class 3.1 drug of Jinan Bainuo Pharmaceutical Technology Development Co., Ltd.; cefuroxime ester dispersible tablets, a generic medicine of Zhejiang Baikang Pharmaceutical Co., Ltd.; and sodium chloride injection, a generic medicine of Hubei Duorui Pharmaceutical Co., Ltd 4 There are 10 drugs completed this week, including 8 chemicals and 2 traditional Chinese medicines Beijing San Fang Dalong Pharmaceutical Technology Development Co., Ltd 1.5 kinds of new drugs mannitol glycerin injection, sodium leucovorin of Tianjin Kang Hong Pharmaceutical Technology Development Co., Ltd and the 3.3 kinds of new drugs, Ji'nan Libo Pharmaceutical Technology Development Co., Ltd lidocaine ophthalmic gel have been approved clinically The details are as follows: