CDE Drug Evaluation Weekly Report (2015.7.19-2015.7.25)

In the review this week (2015.7.26-2015.8.1), 92 drugs (calculated by acceptance number) entered the review status, 82 chemicals, including 2 1.1 categories, 1 1 1.6 category, 30 3.1 categories, 4 3.2 categories, 2 3.4 categories, 6 5 categories, 26 6 categories and 9 imports In addition, there are 4 biological products for treatment, 3 biological products for prevention and 2 traditional Chinese medicine The key points are as follows: 1 Stg-1 injection: This product was developed by Dalian Dean Bioengineering Co., Ltd no information was found, but according to the drug name, this product should be a stg-1 (sGLP-1) According to literature reports, sGLP-1 not only has the function of stimulating islet β cell proliferation and reducing blood sugar, but also has a long half-life, which has a very good prospect of new drug development For today's large number of GLP-1 analogues declared with biological products, the declaration of sGLP-1 with chemicals is a way to expand the field of diabetes drugs As for the results, let's wait for a while 2 Flurbiprofen axetil injection: This product is declared by Shanxi Pude (purchased by Harbin Yuheng Pharmaceutical Co., Ltd.) to apply for new indications that are not listed at home and abroad Flurbiprofen axetil injection is currently marketed for postoperative and various cancer analgesia It is a non steroidal targeted analgesic Lipid microspheres have stronger efficacy, faster onset, longer duration, and are not easy to cause adverse reactions such as gastric mucosal injury At present, only one Taide pharmaceutical company is listed in China This time, Shanxi Pude pharmaceutical company declared new indications 3.DS-5565 tablets: English Name: mirogabalin, developed by the first 3 Pharmaceutical Co., Ltd This product is an alpha2 / delta ligand, which is used to treat chronic pain, including neuralgia, postoperative pain and muscle fiber pain It is the first clinical application in China.