CDE drug review weekly report (March 28, 2016 to April 3, 2016)

Guide: this week, one class 1.1 anti-tumor drug, one class 1 biological product and one class 2 biological product were accepted successfully; in addition, Guangzhou Yuansheng class 1.1 anti-tumor drug, phosphoric acid Yuansheng naridine capsule and Baitai biological long-acting glucagon like peptide-1 analog were reviewed In this issue, 1 The Institute of pharmaceutical research of Chinese Academy of Medical Sciences and Beijing Xiehe Pharmaceutical Co., Ltd jointly applied for 1.1-class chemical drug, pirfazimine and its tablets; 2 The clinical application of jintuximab injection, 2-class anti-tumor biological product of Changchun Jinsai, has been accepted, and now it is in line for review; 3 The clinical application of recombinant anti HER2 domain Ⅱ humanized monoclonal antibody injection of class 1 anti-tumor biological products of Lizhu group was accepted; 4 The evaluation of Guangzhou Yuansheng 1.1 anti-tumor drug phosphoyuanshengnalidine capsule lasted for 9 months; 5 The evaluation of clinical application of pafuramidinemaleate tablet, a treatment drug for Pneumocystis carinii pneumonia; 6 The evaluation of exendin-4fc fusion protein injection, a long-acting glucagon like peptide-1 analogue, was completed; 7 The clinical application of ekuzumab injection, the first drug of alexion for paroxysmal nocturnal hemoglobinuria, was reviewed for the first time in China 8 This week, 71 drugs entered the review process, only 15 in 3.1 categories; 9 This week, 187 drugs were reviewed and approved, 227 drugs were approved, 144 drugs were certified, the most of which was 3.1 categories Introduction to key drugs: This product is jointly declared by Institute of medicine of Chinese Academy of Medical Sciences and Beijing Xiehe Pharmaceutical Co., Ltd no specific indications are known at present, but the name is very similar to that of clofazimine, an anti leprosy drug It is estimated that it may be the optimization of this product Jintuximab injection: This product is declared by Changchun Jinsai It is mainly for the new drug with heavy weight of malignant tumor At present, the target is unknown It is understood that the price of jintuximab injection is about 5000 yuan / dose, 100mg / dose, and it takes about 30000 to 40000 for 6 to 8 doses in a course of treatment Recombinant anti HER2 domain II humanized monoclonal antibody injection: This product is declared by Zhuhai Lizhu monoclonal antibody Biotechnology Co., Ltd as a class 1 biological product for treatment This drug is similar to Roche's trastuzumab and patorzumab, and may be used in the treatment of breast cancer and other cancers At present, many domestic enterprises have applied for anti HER2 humanized monoclonal antibody, and some have obtained clinical approval documents, but it is still far from production This product was declared by Guangzhou Yuansheng in China It was once used as cgx1321 to treat tumor In July 2015, the product entered the CDE review center, with two specifications, which are special approval and major special varieties At present, the review is completed, lasting for 9 months, and it is presumed to be approved clinically Pafuramidine maleate tablets: developed by immtech, this product has been used to treat PCP of HIV / AIDS patients in the United States in phase III test, but the nephrotoxicity was too high and it was stopped halfway This product entered the evaluation center in August 2007 with the acceptance number of jxhl0700219 It was suspended for a long time At present, the evaluation is finally completed I don't know how to live or die Exendin-4 Fc fusion protein injection: This product is declared by Baitai biology, acceptance No cxsl1400049 It is a long-acting glucagon like peptide-1 analog, used for the treatment of type 2 diabetes Before that, Yangzijiang pharmaceutical declared to restructure exendin-4 injection, which was approved in April 2015 This product entered the evaluation center in August 2014 and is a major special product It was issued and supplemented once in September 2015, and now the evaluation is completed Ekuzumab injection: the English name is eculizumab, developed by alexion pharmaceutical company It was first listed in the United States in 2007 It is licensed to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) But it's very expensive For aHUS patients, it costs about $409500 per person per year It's the most expensive drug in the Guinness Book of world records This product entered the evaluation center in July 2012, and was applied by Hangzhou tag with the acceptance number of jxsl1200054 At present, the evaluation has been completed.