CDE drug review weekly report (January 26, 2016 to January 31, 2016)

Highlight 1 - class 1.1 chemicals under review this week: 1) amxetine hydrochloride enteric coated tablets: This product is declared by the Institute of toxicants and drugs, Academy of Military Medical Sciences, Chinese people's Liberation Army, including three acceptance numbers: cxhl1502280, cxhl1502281 and cxhl1502282 Amxetine is a novel SNRIs (5-HT and NE reuptake inhibitors) candidate drug, which is mainly used in the treatment of antidepressant Point 2 --- class 1 biological products in review status this week: 1) Jerry McAb injection: This product is the sixth McAb drug applied for clinical research after the first five McAb biological analogues that have been independently developed and entered the clinical research stage by Jiahe biology, a subsidiary of Watson Biology (stock code sz300142), and also the first innovative therapeutic biological product class 1 new drug This product is aimed at the target of IL-6 At present, there are no similar products aiming at the same target approved for listing at home and abroad The products of Johnson & Johnson and Squibb are still in phase III clinical research stage The drug is the next generation product of TNF target monoclonal antibody (both infliximab and adalimumab belong to this kind of monoclonal antibody) At present, the application is for rheumatoid arthritis, and it is also being studied for other diseases The potential clinical application of the target drug is relatively wide   2) Recombinant human apoptin 2 ligand: This product is a drug developed by Shanghai gebaide Biotechnology Co., Ltd for the treatment of non-small cell lung cancer It has been more than 10 years since now When it first applied for clinical application, the acceptance number was x0403749 (Applied in 2005) Then it obtained the clinical approval document in the same year Haoyi completed the III clinical application in 2012 and applied for production at the end of 2012 (cxss1200022) ）Although it is a major special product, but the road to market is too long There are three times of issuance and supplement in the middle, and there has been a notice of disapproval On January 13, this year, it was in the state of approval, but on January 29, it changed back to the review, and the biggest possibility is to get the clinical approval again See the figure below for status change: point 3 - category 1.1 chemicals under approval after the review this week (overall, the conclusion is very poor) 1) Pegylated insulin stimulating peptide analogue injection: This product is declared by Chongqing Fujin biomedical Co., Ltd (acceptance No cxhl1300389 and cxhl1200761 of raw materials and preparations) for the treatment of type 2 diabetes mellitus, hypodermic injection, once every two weeks At present, we can see the notice of disapproval, which should be killed 2) germinal peptide spray: This product was declared by mega pharmaceuticals (Hefei) Co., Ltd in January 2014 At that time, a total of 3 clinical materials were added to raw materials, including 2 formulations of raw hair peptide eye drops and sprays Spray was mainly used to prevent and treat hair loss caused by various reasons At present, eyedrops are still being reviewed, and the conclusion of spray is also unknown 3) semidone tablets: This product is declared by Zhejiang Xianju Pharmaceutical Co., Ltd., including raw materials and three specifications of tablets For the purpose of production declaration, it is now announced to be withdrawn In addition, noratrix hydrochloride for injection, as mentioned before, is applied for production of approved clinical varieties All in all, after the country increased the clinical examination, many varieties are miserable Highlight 4 ---- nearly 1000 drugs have been approved: 1) 945 drugs (calculated by acceptance number, the same below) have been approved this week, including 891 chemicals, 38 traditional Chinese medicines and 16 biological products 2) of 945 drugs, 843 were approved, 51 were withdrawn and 12 were not approved 3) for 891 chemicals, 833 were approved, and the approval rate was 93.5% Among them, the more approved varieties are as follows: 4) for 38 traditional Chinese medicines, 33 announcements were withdrawn, and 5 conclusions were not clear 5) for 16 biological products for treatment, 10 of which are approved for clinical use, the details are as follows: the clinical situation of biological products for treatment should be focused on 5 --- 510 drugs and 339 clinical approval documents have been prepared and verified this week In addition, according to the statistics, the National Bureau issued a total of 1550 approvals this month, including 1098 clinical approvals Do you want to be quiet again?