[weekly] Haizheng is stepping out of the shadow of EU attack, and irbesartan hydrochlorothiazide tablet has won the US Anda

Introduction: 1 The recombinant anti HER2 humanized monoclonal antibody for injection developed by Shanghai Fuhong Hanlin Biotechnology Co., Ltd has completed phase I clinical research, which is confirmed to be equivalent to the original research drug, and phase III clinical trial will be started in the near future 2 The six chemical generic drugs submitted by Chengdu Kanghong Pharmaceutical Group Co., Ltd have obtained clinical approval 3 The phase I clinical trial work of Guizhou bailing Group Pharmaceutical Co., Ltd on the tifentai project of chemical medicine class 1 new drug has been completed 4 Jiangsu Hengrui this week obtained the clinical approval documents of rofustite tablets and the production approval documents of drugs such as Poppy ethyl iodide oil 5 This week (2016.10.17-2016.10.21), 46 drugs (calculated according to the acceptance number, the same below) entered the CDE evaluation center, including 4 traditional Chinese medicine, 29 chemical drugs, 10 biological products and 3 pharmaceutical excipients Nl-101 and its injection preparation (acceptance No.: cxhl1600242, cxhl1600243), the only intellectual property owner of Hangzhou Minsheng Pharmaceutical Co., Ltd Nl-101, a new chemical class 1 drug and its injection preparation submitted by Minsheng Pharmaceutical Co., Ltd., have been undertaken by CDE Nl-101 is a compound synthesized by linking the active group of the histone deacetylase inhibitor Saha and the alkylating agent bendamostine The analysis shows that the new compound not only has DNA damage effect on cancer cells, but also has high HDAC inhibition effect 2 Ak0529 and its enteric coated capsules (acceptance No.: cxhl1501867, cxhl1501868) submitted by Shanghai Aike Baifa Biomedical Technology Co., Ltd have been reviewed this week Phase II clinical trials are underway in the United States Ak0529 is a new type of small molecule anti RSV drug, which can specifically inhibit the replication of RSV by preventing virus invasion and syncytial formation This product is the first class of new antiviral drugs for RSV infection in the world, which fills the gap in the treatment of RSV infection in the world The phase II clinical trial of ak0529 was carried out for hospitalized children with RSV infection, which marks a great step forward in the process of aikebaifa's global development of the drug to meet the needs of clinical treatment of RSV infection 3 The brief application for new drug of irbesartan hydrochlorothiazide tablets declared by Zhejiang Haizheng Pharmaceutical (Hangzhou) Co., Ltd to the US FDA was approved Last month, Haizheng Taizhou plant was withdrawn GMP certificate by the European Union, which caused a great uproar in the industry Recently, Haizheng Pharmaceutical Co., Ltd announced that Hangzhou company received the notice from the FDA of the United States, and irbesartan hydrochlorothiazide tablets obtained anda, which undoubtedly brought a good medicine to the shadowed Haizheng pharmaceutical industry Irbesartan hydrochlorothiazide tablet is a compound preparation of angiotension Ⅱ receptor antagonist and thiazide diuretics It is used to treat patients whose blood pressure can not be effectively controlled by irbesartan or hydrochlorothiazide The original research drug of irbesartan tablets was developed by Sanofi company The domestic manufacturers mainly include Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd and Zhejiang Huahai Pharmaceutical Co., Ltd According to IMS data, the global sales of the drug in 2015 was about 487 million US dollars, and the sales in the domestic market was about 105 million US dollars 4 Moxifloxacin hydrochloride capsule (acceptance No.: cxhl1301211), a new chemical class 5 new drug declared by Henan Tianfang Pharmaceutical Co., Ltd (now renamed as "Tianfang Pharmaceutical Co., Ltd."), has recently obtained the clinical trial approval They are broad-spectrum and antibacterial 8-methoxyfluoroquinolones They are mainly used in the treatment of adult upper and lower respiratory tract infections, as well as skin and soft tissue infections Moxifloxacin is a kind of super broad-spectrum quinolones developed by Bayer company in Germany It is mainly used to treat adult upper and lower respiratory tract infections At present, the product has been used in clinical practice in many countries (including China), and the imported drugs approved for listing in China include moxifloxacin hydrochloride sodium chloride injection and moxifloxacin hydrochloride tablets of Bayer company of Germany, moxifloxacin hydrochloride injection produced by Nanjing Youke Pharmaceutical Co., Ltd and Chengdu Tiantaishan Pharmaceutical Co., Ltd., without capsule According to the data, in 2015, the global sales volume of such products was about $42 million, and the domestic sales volume was about $612.37 million According to the antibacterial spectrum, moxifloxacin is listed as the fourth generation quinolones, its excellent mechanism of action has driven the market sales, strong cell tissue penetration has been unanimously recognized by doctors and patients Therefore, the development of the drug may bring unexpected results Note: This article is the original manuscript of the author of yaozhi.com, welcome to reprint, please indicate the source and author when reprint, thank you!