CDE drug review weekly report (2015.8.2-2015.8.8)

1 in the review this week (2015.8.2-2015.8.8), 89 drugs (calculated by acceptance number) entered the review status, 83 chemicals, including 35 drugs in 3.1, 2 drugs in 3.2, 1 drug in 3.3, 4 drugs in 5, 38 drugs in 6, and 2 drugs imported In addition, there are 1 Traditional Chinese medicine, 3 biological products for treatment and 1 biological product for prevention The key points are as follows: 1 Sakubitravalin tablets: the English name of this product is valsartan sacubitril, which is also the famous anti heart failure drug lcz696 of Novartis : LCZ696 combines the Valsartan of Novartis and the experimental drug Sacubitril Sacubitril can block the mechanism of action of the two peptides threatening to reduce blood pressure, while valsartan can improve vasodilation, stimulate the body to excrete sodium and water, both of which play a common pharmacological role through reaction; it has a unique mode of action, which can reduce the strain of heart failure This product was approved by FDA for listing in July 2015 At present, Novartis has obtained the clinical approval (August 2010) of this product in China, and Jiangsu Wanbang biochemical is the first enterprise applying for this product in China 2 Cangreleo for injection: This product is a reversible inhibitor of P2Y12 It was first developed by a small company in the UK and then acquired by AstraZeneca In 2003, medicine's company acquired the development right of cangreleo from AstraZeneca In June 2015, it was approved by FDA for listing Although the listing process was slightly tortuous, it was finally approved for listing after the indomitable efforts of Medicine's company Because of its short half-life, it can be used to avoid coronary artery occlusion caused by coagulation in adult patients during percutaneous coronary intervention At present, the import of this product has been approved for clinical use in China, and Jiangsu aosaikang Pharmaceutical Co., Ltd., a domestic enterprise, is the first to declare in category 3.1 this week 2 no drugs are in the approval status this week CDE has too many things to do recently This week, it didn't approve drugs 3 There are 31 drugs approved this week, all of which are chemical drugs Key drugs: 1 Hemay005 tablet: This product is a phosphodiesterase 4 inhibitor, which is used to treat psoriasis It was developed by Hainan Hailing Chemical Pharmaceutical Co., Ltd and entered the CDE evaluation center in June 2013 It is a special approved variety It was supplemented twice in 2014 Now it is approved for clinical use See Table 1 for the approved chemical information Some drugs' serial numbers have been added into this table These drugs have basically come to a conclusion without review It is speculated that there is something wrong with these drugs, which is only for reference There are 39 drugs completed this week, including 34 chemicals, 2 biological products for treatment, 1 biological product for prevention and 2 traditional Chinese medicine Key drugs: 1 Porcine fibrin adhesive: the main components of this product are fibrin and coagulation factors, which have the functions of blocking, biological hemostasis, adhesion, promoting wound tissue healing, preventing tissue adhesion and local drug slow-release It is widely used in surgery At present, there are only two domestic enterprises listed in this product, and this week, the third enterprise Harbin Hanbang Medical Technology Co., Ltd approved the listing of pig derived fibrin adhesive for prevention biological products See Table 2 for the chemical drugs after the preparation.