CDE drug review weekly report (March 7, 2016 to March 13, 2016)

This week, no new 1.1 kinds of drugs have entered the state of review, and the 1.1 category of the essence medicine has been reviewed by the drug group The Tianjin Institute of pharmacy has approved the second 1.1 new drugs titarejing tablets this month Highlight 1 Dalulinastat, a new anti AIDS drug of Johnson & Johnson, has been applied for clinical application for the first time in China It is speculated that it is a compound preparation containing dalunavir 2 The 1.1 class of pharmaceutical products, the best medicine, was finished in the approval stage, and lasted nearly 11 months 3 The class 1.1 hypoglycemic drug of Tianjin Pharmaceutical Research Institute was approved and approved clinically 4 87 drugs (calculated according to the acceptance number, the same below) entered the review stage this week, including the second specification of fudanafei tablet of xuanzhu medicine and 8 traditional Chinese medicines 5 349 drugs have been approved this week, 246 of which have been approved for clinical use The most involved acceptance numbers are wotexitin tablets and avaanafil tablets (all 9) In addition, 62 of them have been withdrawn 6 This week, there is another 6.1 traditional Chinese medicine compound Shenxiong dropping pill approved for clinical use! 7 This week, 337 drugs have been certificated, 181 of which have been approved for clinical use, 124 have been announced for withdrawal, and 4 have been withdrawn The key drug is to introduce the times of 002349 times of the tablets: the product is declared by the essence Pharmaceutical (stock code number 1.1), and it is the 1.1 generation of the target drug The product was reviewed by CDE review center in April 2015, and has been reviewed and is in approval status Tegrinone tablets This product was declared by Tianjin Institute of pharmaceutical research (acceptance No cxhl1500167, cxhl1500168, cxhl1500169) It is the fourth sodium glucose cotransporter 2 (SGLT2) inhibitor in China after hengglizine in Jiangsu Hengrui, jiaglizine in Shandong xuanzhu, and aigglizine in Shanghai Ellis Since then, there is jungglizine in dongyangguang, which is currently used to treat type 2 sugar Urinary disease This product entered the evaluation center in March 2015, which is a special approved variety At present, it has been approved for clinical use, lasting for one year.