CDE drug review weekly report (2015.9.6-2015.9.12)

In the review this week (2015.9.6-2015.9.12), 87 drugs (calculated according to the acceptance number, the same below) entered the review state, 81 chemicals, double the last week, including 3 1.1 categories, 27 3.1 categories, 1 3.2 categories, 1 3.3 categories, 35 6 categories, 14 imports Category 3.1 and category 6, which entered the status of waiting for review this week, increased significantly compared with last week, while there were 14 imported chemicals that did not enter the review last week There are also four biological products for treatment, which are basically the same as last week, namely 1 class 1, 1 class 2 and 2 class 15 In addition, two imported pharmaceutical excipients are also under review In this week's reexamination drug treatment field, there are mainly 13 digestive tract and metabolism, 11 respiratory system, 11 nervous system, 9 miscellaneous categories, 8 anti-tumor drugs and immunomodulators, 6 reproductive urinary system and sex hormones, 6 systemic anti infectives, 5 muscle bone system, 4 cardiovascular system, 4 blood and hematopoietic organs, etc The key points are as follows: 1 Konitinib: This product is the chemical medicine declared by Beijing Kangchen Pharmaceutical Co., Ltd in category 1.1, including the acceptance number of konitinib raw materials and 2 tablets At present, the editor has not found any information about konitini, and any known friends can leave messages in the background
2 Combined injection of recombinant anti Ebola virus monoclonal antibody (mil77): Class 1 declaration of Institute of basic medicine, Academy of Military Medical Sciences of the people's Liberation Army, is another biological product related to Ebola virus after class 1 recombinant Ebola virus vaccine (cxsl1500017) of the Academy of Military Sciences in February this year Previously, the recombinant Ebola virus vaccine was approved for clinical application in only 20 days How long it will take for the antibody to be approved remains to be seen On approval There are 4 drugs in approval status this week, a sharp drop compared with last week's blowout of drugs in approval is chemical drugs, among which 3 acceptance numbers are 1 variety, i.e 1.1 new drug hs-10234 tablets of Jiangsu Haosen Pharmaceutical Co., Ltd., which is an antiviral nucleoside analogue; 1 3.1 is acetazolamide for injection of Henan Zhongshuai Pharmaceutical Technology Development Co., Ltd., which is cardiovascular Systemic drugs, used to treat heart failure and arrhythmia, is the first time acetazolamide has entered the approval stage There are 48 drugs that have been approved this week, a slight increase compared with last week, including 45 chemicals and 3 traditional Chinese medicines Among the chemicals, 37 were classified as 3.1, 1 as 5, 4 as 6, and 3 as imported In traditional Chinese medicine, there are two 6.1 categories and one is imported Nearly 20 drugs have been approved for clinical use this week, such as Prozac and its injection from Guoyao Yixin Pharmaceutical Co., Ltd., rofluoristec and its tablets from Shandong Luoxin Pharmaceutical Co., Ltd., rofluoristec and its tablets from Tianjin Kanghong pharmaceutical science and Technology Development Co., Ltd Donepezil hydrochloride orally disintegrating tablets of Sichuan Shenghe Pharmaceutical Co., Ltd are undergoing a three in one review and are expected to be approved for listing soon See attached table 1 for approved chemicals There are 44 drugs approved this week, including 24 chemicals, 10 biological products for treatment, 9 biological products for prevention and 1 Traditional Chinese medicine The key points are as follows: 1 Split vaccine of influenza A (h7n9): Shanghai Institute of Biological Products Co., Ltd applied for class 1 new drug, biological products for prevention, to prevent influenza A (h7n9) This product was undertaken by CDE in May 2014, and the certification has been completed See attached table 2 for the chemical drugs after the completion of the preparation Attached: