China's new drug research and development progress in May 2014

1 Chemical drugs 1.1 research and development progress, drug name, action target, indication, manufacturer category Clinical asc08 NS3 / 4A declared by Haikou pharmaceutical factory of liver and kidney fibrosis Clinical application of proteinase inhibitor HCV infection with Geli biological for fg-4592 hif-ph inhibitor chronic nephropathy , end-stage renal disease Beijing fabojin declare clinical flumatinib BCR ABL inhibitor chronic myeloid leukemia Jiangsu Haosen Pharmaceutical Co., Ltd approved the production of? Busulfonate tumor chemosensitizer Liaoning Lantian Pharmaceutical Co., Ltd Approval of production? Sucrose gel bacteria infection Hebei Medical University approved the production of Haikou pharmaceutical factory Declaration of flufenidone: according to the announcement of Hainan Haiyao, Haikou pharmaceutical factory and Central South University signed a technical cooperation agreement in November 2013 to jointly develop flufenidone for the treatment and prevention of chronic viral hepatitis, alcoholic liver disease, toxic liver disease, biliary cirrhosis, and renal fibrosis caused by chronic kidney disease Flufenidone is a kind of analogues of pirfenidone, with a patent of wo2009039773 / cn101652138 A large number of papers can be retrieved from China HowNet Asc08 is an NS3 / 4A protease inhibitor introduced by Geli from Roche, namely danoprevir (rg7227, itmn-191) Roche was purchased from intermune Inc As the drug is an old generation of anti hepatitis C drug, which needs to be combined with interferon, it can not be taken orally However, the new generation of pure oral anti hepatitis C drug has occupied the market, and the combination of anti hepatitis C therapy is ready to develop Roche has not promoted danoprevir as a key project, and it is still in phase II Fg-4592 of fibrogen in Beijing has applied for clinical application according to class 1.1 new drug procedure (imported in 2009) The drug is hif-ph inhibitor, which can prevent HIF from being ubiquitinated and degraded, and help cell self-protection At present, phase II test has been completed AstraZeneca acquired the drug in 2013 with a down payment of $350 million and a mileage of $465 million Flumatinib of hausen is an imatinib analogue, which has been approved by CFDA for the treatment of chronic myeloid leukemia This is hausen's second class 1.1 new drug after nitzomorpholine, and the second small molecule targeted anticancer drug after exetane in China The patent of the drug compound is wo2006069525 / cn1939910 (the first inventor is sun piaoyang, and the Chinese patent has been withdrawn?) , the process patent is cn102796079, the crystal patent is cn102816146, cn102816147 Because imatinib generic drugs have been on the market, flumazetinib is of little significance Busulfonyl acid is a tumor chemotherapeutic sensitizer developed by Shanghai Medical University and Shanghai Zhongmin new technology, which belongs to the ninth five year national key project of the Ministry of science and technology, with the patent of cn1084509 The original plan was to complete phase II in 2002, phase III and trial production in 2003 In 2005, the sales volume was over 100 million However, due to various reasons, the plan was completed ten years later The sucrose gel from Hebei Medical University has obtained CFDA production approval According to the Shijiazhuang Daily reported in February 3, 2013, sucrose gel is the world's first and officially approved It is expected to become second new drugs in our province since the founding of the people's Republic of China The sales revenue in normal years can reach 1 billion yuan This report is false In the 06 issue of the Journal of Peking University, phase II clinical trial of sucrose gel in the treatment of bacterial vaginosis was reported in the 2010 issue of the Journal of the Journal of medicine To be continued > >