CDE drug review weekly report (July 25, 2016 to July 31, 2016)

1 This week (July 17-july 24, 2016), only 11 drugs (according to the acceptance number, the same below) entered the review stage, all of which are 6 types of preparations, and accepted in 2015 This year, there are fewer and fewer drug undertakers 2 The clinical application review of plb1003 capsule, a class 1.1 antitumor drug, was completed; this product was undertaken in December 2015, including raw materials and two specifications of capsules, which belongs to special approved varieties, and has not experienced supplement in the middle At present, it has been reviewed and is in the approval stage, so it is presumed to be approved clinically 3 The clinical application review of the biosimilars of hengruibevacizumab injection (a humanized anti VEGF monoclonal antibody) was completed ; this is the second time Hengrui has applied for this product's analogues The first undertaking date is January 2014, and the review procedure was terminated in June 2014 Two months later, Hengrui reapplied to enter the review procedure After a supplement, the review is now completed, and it is presumed that Hengrui should be approved clinically 4 For category 3.1 reviewed, it mainly includes varieties with more application, such as aprost tablets, trogliptin Succinate Tablets, nedanib soft capsules and vortexitin hydrobromide tablets 5 The first review of the clinical application of Zaihuan and Sanofi anti asthma test drug sar153191 injection (dupilumab) in China was completed This product is an anti-il-4r α monoclonal antibody, blocking Th2 pathway, so as to control asthma In addition to asthma, this product has also been tested for the treatment of atopic dermatitis and other specific diseases Once it is on the market, it is expected to become a new heavyweight drug 6 The first review of Novartis anti-tumor drug fgf40 in domestic clinical application has been completed This product is a fibroblast growth factor receptor 4 (FGFR4) inhibitor, which was introduced in review weekly report 66 7 The clinical application and approval of sc10914 tablets of Jiangxi Qingfeng 1.1 anti-tumor drug have been completed This product was undertaken in June 2015, and was introduced in 44 issues of the review weekly report It is a special approved variety, and has been approved for clinical use.