CDE drug review weekly report (2016.04.18-2016.04.24)

This week, another 1.1-class chemical drug sph1188-11 from Shanghai Pharmaceutical entered the CDE evaluation center, and the evaluation of Geli bio's 1.1-class new anti hepatitis C drug asc16 and Guangzhou Nanxin pharmaceutical's 1.1-class new anti-tumor drug metofenide was completed This week's highlights: 1 Shanghai Pharmaceutical Group, after the recent review of 1.1 class chemicals, sph3127 tablets, another 1.1 class chemicals, sph1188-11, entered the stage of waiting in line for review; 2 Taizhou mabotaco pharmaceutical declared class 2 biological products, cmab809; 3 Geli biological, class 1.1 anti hepatitis C drugs, asc16 tablets, completed the review 4 Guangzhou Nanxin Pharmaceutical Co., Ltd has completed the review of metoclopramide tablets, a new anti-tumor drug of category 1.1; 5 This week, a total of 125 chemicals have been reviewed, 42 of which are of category 3.1, 31 of which are imported and 16 of which are imitated Among them, Aerjian has completed the review of bemeprost coating which was first applied in China, and the import application of Xindong biotechnology clopidogrel bisulfate tablets is presumed to be not approved 6 This week, the clinical application review of three class 2 monoclonal antibody biological products was completed, namely, anti-human tumor necrosis factor - α monoclonal antibody injection of Beijing green bamboo, recombinant humanized anti VEGF monoclonal antibody injection of baiaotai, and recombinant human mouse chimeric anti-CD20 monoclonal antibody injection of Shenzhen Wanle Recently, monoclonal antibody has also been wildly developed in China 7 50 drugs have been approved this week, 8 of which are new drugs, except for one imported drug for re registration, the rest are new drugs, among which the listing application of Yantai Zhongzhou gyro silver chip capsule has been killed; the introduction of key drugs sph3127 tablets: the evaluation of sph3127 tablets of Shanghai Pharmaceutical has just been completed, another new drug sph1188-11 tablets entered the CDE evaluation center this week This product is designed to be 100mg, which is used for the treatment of non-small cell lung cancer Cmab809: This product is declared by mabotaco Pharmaceutical Co., Ltd., and the target and indications are unknown Mabotaco is a one-stop platform service provided by the antibody R & D team of Shanghai Zhangjiang Biotechnology Co., Ltd (National Key Laboratory of antibody drugs and targeted therapy), which is committed to the industrialization of a series of national innovative antibody drugs Existing varieties: recombinant anti EGFR human mouse chimeric monoclonal antibody for colorectal cancer treatment, recombinant human LFA3 antibody fusion protein for psoriasis treatment, etc At present, two biological products are declared in China, the other is recombinant anti TNF α all human monoclonal antibody injection Asc16 tablets: This product is declared by Geli biology as an NS5A inhibitor for the treatment of hepatitis C Geli has developed two anti hepatitis C drugs, the other is asc-08 (danoprevir), which is an NS3 / 4A inhibitor It obtained clinical approval in China in 2015 At present, acs16 has also been reviewed If it successfully obtained clinical approval, it must be a combination of drugs It is not impossible to develop compound drugs in the future Metoclopramide tablets: This product is declared by Guangzhou Nanxin Pharmaceutical Co., Ltd., which has been purchased by Hunan Nonferrous Kaibai biopharmaceutical Co., Ltd Metafeni speculated that it was based on sorafenib, which was also an inhibitor of VEGFR and RAF Last July, CDE hosted the review, which was introduced by the editor at that time It took nine months and has been reviewed this week.