CDE Drug Evaluation Weekly Report (2015.11.15-2015.11.21)

During the review this week (2015.11.15-2015.11.21), 91 drugs (calculated by acceptance number, the same below) entered the review status, with a slight decrease in the number compared with last week Among them, 77 chemical drugs, the most are 3.1, 33; the second is 6, 32; the third is 1.1 and 5, 4 each, another 2 imported and 2 3.3 In addition, there are 8 therapeutic biological products, 3 preventive biological products and 3 traditional Chinese medicine In this week's review, the drugs mainly focus on the following treatment areas: 21 anti-tumor drugs and immunomodulators; 16 drugs for cardiovascular system; 10 drugs for nervous system; 9 drugs for digestive tract and metabolism; 8 drugs for systemic anti infection, etc Key drugs: prosemode and its tablets: This product is a 1.1-class chemical drug The Institute of medicine of Chinese Academy of medical sciences will declare the raw material drug of prosemode, and Beijing Xiehe Pharmaceutical Co., Ltd will declare the tablets of prosemode At present, the editor has not found any information about the drug According to the name of the drug, it is speculated that the product is an immunomodulator Friends who know the specific information can tell it in the background Hssyo-001 for injection: the raw material code is hssyo-001-3s This product is applied for by Sichuan sanowei new Biotechnology Co., Ltd as a 1.1 chemical This product is an anti-tumor drug, the specific target and indications are unknown A total of 77 drugs entered the approval process this week, double the number last week Among them, there are 74 chemical drugs, the most of which are 6 categories, with a total of 31; the second category is 3.1, with a total of 21; the third category is imported, with a total of 14; in addition, there are 4 categories 3.2, 2 categories 3.3 and 2 categories 5 In addition, there are two 15 categories of biological products for prevention and one for import of biological products for treatment Following the slow steps of the previous week, the National Bureau stepped up slightly this week Beijing Sihuan Pharmaceutical Co., Ltd and Jiangsu wangao Pharmaceutical Co., Ltd have all been approved for clinical use, including kabalatin tartrate capsule, pramipexole hydrochloride tablets of Qilu and Guoyao, terriframine tablets of Sanofi, and quetiapine fumarate sustained-release tablets of AstraZeneca This week, 276 drugs were approved, 274 chemicals and 2 pharmaceutical excipients were approved The number of chemicals is about 20% less than last week There are 154 categories 6, 54 imported, 39 categories 3.1, 7 categories 5, 6 categories 3.2, 4 categories 3.3 and 6 categories 3.4 More than half of the drugs approved this week have been approved for clinical use, including 7 acceptance numbers for felodipine sustained release tablets, 6 acceptance numbers for lucotinib phosphate tablets, 5 acceptance numbers for rosuvastatin calcium tablets, 4 acceptance numbers for pravastatin sodium tablets, 4 acceptance numbers for atorvastatin calcium tablets, 4 acceptance numbers for iparinone tablets and 4 acceptance numbers for gadolinium butoxide injection, Valsartan amlodipine tablets involved in three acceptance numbers, risinotide injection involved in three acceptance numbers, lamivudine tablets involved in three acceptance numbers, sufentanil citrate injection involved in three acceptance numbers, etc Key drugs: 1 Sabin polio inactivated vaccine (Vero cell): This product is a class 1 new drug applied by Beijing Kexing Biological Products Co., Ltd for biological products for prevention Used to prevent polio At present, it has been approved for clinical use 131 drugs have been certified this week, 1 / 2 of last week Among them, there are 126 chemicals, including 45 imported drugs, 33 6 categories, 27 3.1 categories, 10 3.3 categories, 6 5 categories, 3 3.2 categories and 1 1.1 category In addition, there are 3 biological products for treatment and 2 traditional Chinese medicine One third of the drugs were approved for clinical use, including 4 cabalatine heavy Tartrate Capsules, 2 ibuprofen injection, 2 metoprolol succinate, 2 fexofenadine hydrochloride tablets and 2 moxipril hydrochloride tablets.