CDE drug review weekly report (January 18, 2016 to January 25, 2016)
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Last Update: 2016-01-26
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Source: Internet
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Author: User
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There are a lot of key drugs and key drugs Please read them patiently Maybe you focus on the last part: 1 Nanofloxacin malate capsule: This product was mentioned last week, and the three in one review was completed It needs to be approved However, this week's status has changed from being approved to being reviewed I don't know what's going on! The status change is shown in the following figure: 2 Linalopeptide capsule: linalopeptide was developed by Ironwood company in the United States, and was approved by the U.S FDA on August 30, 2012 This product is a guanosine cyclase C (GC-C) agonist, which combines with intestinal GC-C, resulting in an increase in the concentration of cGMP in and out of cells The increase of cGMP in cells can stimulate the secretion of intestinal fluid, accelerate the migration of gastrointestinal tract, and increase the frequency of defecation; the increase of cGMP in cells can reduce the sensitivity of pain nerves and the pain in intestine It is a hard capsule for the treatment of constipation irritable bowel syndrome (IBS-C) and chronic idiopathic constipation (CIC) In 2013, the product was approved for clinical use, and was declared by Hangzhou tiger The test was completed in early 2015 (Registration No in CDE: ctr20132182) This week, AstraZeneca pharmaceutical company declared the clinical application for import of the product (jxhl16000007) It is speculated that it should be directly approved for listing 3 Jiagelijing tablet: This product is declared by Shandong xuanzhu, a subsidiary of Sihuan pharmaceutical It is a 1.1-class chemical medicine, which is used to treat type 2 diabetes At present, many imported and 1.1-class "Liejing" hypoglycemic drugs have been declared in China, and there will be great competition in the future This product entered the CDE evaluation center in October 2014 The acceptance numbers of the raw material box preparation are cxhl1400849 and cxhl1400850 It is a special approved product and has not undergone the issuance and supplement At present, it has been reviewed and is in the approval status 4 Sodium pyruvate inhaler: This product is a class 1.1 new drug developed by Jiangsu Changtai Pharmaceutical Co., Ltd for the treatment of chronic obstructive pulmonary disease This product entered the CDE review center in February 2014, with three acceptance numbers (cxhl1301268, cxhl1301269, cxhl1301270) for raw materials and preparations It is a special approved variety It was issued and supplemented in March 2015 At present, the review is completed, and it is in the approval status, so it is presumed to be approved clinically 5 Shr-1210 for injection: This product is a class 1 PD-1 monoclonal antibody independently developed by Hengrui pharmaceutical It is one of the most popular monoclonal antibody targets at present It entered the CDE Evaluation Center (acceptance No cxsl1400153) in January 2015 It is a major special product There was a supplement at the end of December 2015 At present, the evaluation is completed and in the approval stage No accident should be the clinical approval It is reported that Hengrui sold the foreign rights and interests of the product to Incyte company in the United States with a down payment of US $25 million plus a total amount of US $770 million, realizing the first transfer of innovative biological drugs by Chinese enterprises 6 Tab008 monoclonal antibody injection: This product was declared by Dongyao Pharmaceutical Co., Ltd as a class 2 therapeutic biological product The small editor searched the network and did not find the information of this product, and the official website did not disclose the target and other information! Well, for the first time, Xiaobian really knows that there must be some friends like me Let's say here: Dongyao Pharmaceutical Co., Ltd., founded in July 2010, is a high-tech biomedical enterprise specializing in the research and development, production and marketing of new anti-tumor drugs, specializing in biological products for treatment, anti-tumor chemicals and special dosage forms of drugs, etc the company's general manager The Department is located in Suzhou, China 7 Isothiafludine dry suspension: This product is a new non nucleoside anti hepatitis B virus (HBV) 1.1 drug declared by Shanghai Institute of medicine, Chinese Academy of Sciences This product was first declared as a capsule in 2010, and was approved in 2013 At present, several phase 1 clinical trials are being carried out in China In June 2014, the application for dry suspension was made, which was a special approved variety At present, the approval has been completed, and the clinical approval has also been obtained 8 Sklb1028 capsule: This product is a multi-target tyrosine kinase inhibitor designed by Yang Shengyong of Sichuan University It was transferred to Shiyao group at a price of 20 million RMB After that, it was declared by Zhongqi pharmaceutical group of Shiyao group, with two specifications (acceptance No cxhl1400261, cxhl1400262) Sklb1028 has inhibitory effect on wild-type EGFR and L858R mutant EGFR, so it is clinically developed for non-small cell lung cancer; it also has inhibitory effect on FLT3, BCR ABL and T315I mutant BCR ABL, so it is also used for acute myeloid leukemia This product was undertaken in March 2014 It is a special approval and major special variety At present, it has been approved and approved clinically 9 Brozopine sodium for injection: This product is a new compound developed by Professor Chang Junbiao of Zhengzhou University on the basis of butylphthalide It is intended to be used for the treatment of mild and moderate acute ischemic cerebral infarction In November 2014, it was transferred to AoXiang Pharmaceutical Co., Ltd with 45 million yuan, which set the highest record for single achievement transfer of Zhengzhou University This product was applied by Zhengzhou University in March 2015, with a total of 2 specifications, which are special approval and major special varieties At present, the approval is completed and the product is approved for clinical use The above is the key drug of this week The following is a small compilation for you to analyze more than 1000 varieties approved this week Nearly new year's National Bureau so hard, is also dedicated! The total number of drugs approved in this week is 1052 (calculated according to the acceptance number, the same below), including 994 chemical drugs, 47 traditional Chinese medicines and 11 biological products Of the 1052 drugs, 797 were approved and 185 were withdrawn Of the 797 approved clinical drugs, 787 are chemical drugs, the most of which are 6 categories, 390 in total; the second is 3.1 categories, 294 in total, and 7 are 1.1 categories Among the 787 approved clinical chemical drugs, the drugs with the most acceptance number are clopidogrel bisulfate tablets (15), apixaban tablets (14), and atorvastatin calcium tablets (14).
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