CDE Drug Evaluation Weekly Report (2015.5.10-2015.5.16)

In the review this week (2015.5.10-2015.5.16), a total of 111 drugs (excluding supplementary application and review, calculated according to the acceptance number, the same below) entered the review process, including 104 chemicals, 7 biological products for treatment, and the key drugs are as follows: 1 Nike tinib is 1.1 declared by Guangzhou Shunjian biological medicine technology Co., Ltd The specific indications and targets for the treatment of tumors are unknown At present, the company is mainly engaged in the research and development of original small molecule targeted personalized anti-tumor drugs of category 1.1 At present, it has applied for two new drugs of category 1.1, and the other is ketamine declared in 2014 2 Vonolazan fumarate is a new kind of gastric acid secretion inhibitor belonging to potassium competitive acid blocker It can stop gastric acid secretion in advance by inhibiting the binding of K + to PPI in the last step of gastric acid secretion of gastric parietal cells, which has a strong and lasting inhibiting effect on gastric acid secretion In December 2014, it was first approved to be listed in Japan The first enterprise to be declared in China is Central America and East China At the end of April 2015, it applied for clinical application This month, two enterprises followed the pace of Central America and East China to declare the clinical application of this product, among which Ruiyang Pharmaceutical Co., Ltd applied for clinical application with fluorolazan fumarate 3 Pabasinib, namely pabxilib, is the drug developed by Pfizer to treat breast cancer Qilu first applied for this product on April 22, 2015, and hausen is the second in China However, in this time difference, I don't know who can get the approval first, and the market is even more unknown 4 Olaponi, developed by AstraZeneca, is a poly ADP ribose polymerase (PARP) inhibitor for women who may or may be suspected of BRCA-1 or BRCA-2 mutations and who have undergone three or more chemotherapy treatments for ovarian cancer progression This product was approved by FDA in December 2014 In May 2015, Shandong Luoxin and Jiangsu Haosen simultaneously applied for clinical application in China, which is the top two in China 5 Propranolol hydrochloride oral liquid is a new dosage form of beta blocker propranolol The oral liquid of this drug overturns the previous indications In 2014, FDA approved it for use in infant hemangioma There is no manufacturer declaration in China, Wuhan Kefu new drug Co., Ltd is the first one in China In addition, this week, Sichuan Kelun Pharmaceutical Research Institute Co., Ltd continued to declare trogliptin Succinate Tablets, wave after wave, very fast! Second, three drugs are under approval this week, all of which are chemical drugs, namely, aripitan and its capsules (cxhl1100509, cxhl1100510, class 3.1) of Chengdu Dior Pharmaceutical Group Co., Ltd., guanidine hydrochloride (cxhl1100519, class 3.1) of Jinan Bainuo Pharmaceutical Technology Development Co., Ltd No drugs have been approved this week Three approvals are completed, 11 drugs in total have been approved this week, all of them are chemical drugs, 7 of them are imported, and 4 of them are re registered: Adibammonium powder inhaler is a long-acting anti mycorrhizal drug jointly developed by almirall pharmaceutical company of Spain and forest Laboratory of the United States It was approved by FDA of the United States in July 2012 and was used for long-term maintenance treatment of bronchospasm caused by chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema At present, only Shanghai kangbaorui medical clinical research Co., Ltd has applied for the approval of clinical application In addition, the company has also applied for the compound inhaler of this product and formoterol Other drugs are as follows: