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    Home > Medical News > Latest Medical News > [weekly] the new indications of "hydroxytriptolide tablet", a new class 1 new drug of Shanghai Pharmaceutical Chemistry, have been accepted

    [weekly] the new indications of "hydroxytriptolide tablet", a new class 1 new drug of Shanghai Pharmaceutical Chemistry, have been accepted

    • Last Update: 2017-06-02
    • Source: Internet
    • Author: User
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    1 Jiangsu Hengrui Pharmaceutical Co., Ltd recently obtained the approval of clinical trial of 6 kinds of propofol medium / long chain fat emulsion injection 2 The eye drops of recombinant human keratinocyte growth factor-2 submitted by Guangdong Jinan gene drug Engineering Research Center Co., Ltd have been accepted by CFDA 3 MSD's four price HPV vaccine product is the world's first cancer vaccine, which has been approved for market this week 4 Chengdu Kanghong Biotechnology Co., Ltd received the registration approval for the new indication of conbercept ophthalmic injection: "vision reduction caused by choroidal neovascularization (pmcnv) secondary to pathological myopia (PM)" 5 This week (2017.05.22-2017.05.27), 93 drugs (calculated by acceptance number, the same below) entered the CDE evaluation center, including 8 traditional Chinese medicine, 66 chemical drugs and 19 biological products Shanghai Pharmaceutical Group Co., Ltd and Shanghai Pharmaceutical Research Institute of Chinese Academy of Sciences jointly developed a new chemical class 1 drug hydroxytriptolide tablets (cxhl1700108, cxhl1700108) clinical trial application received CFDA acceptance 2 Hydroxytriptolide is a derivative of triptolide It was declared as "rheumatoid arthritis" in 2008 and obtained the approval of clinical trial in 2009 At present, phase I clinical trial has been completed This declaration increases the new indications of the drug in the treatment of AIDS chronic abnormal immune activation At present, the same kind of research at home and abroad are in the stage of clinical exploration, and there are no products for chronic abnormal immune activation in the treatment of AIDS on the market 2 Jiangsu Hengrui Pharmaceutical Co., Ltd and its holding subsidiary Shanghai Hengrui Pharmaceutical Co., Ltd will carry out phase II clinical trial of shr4640 tablets recently In 2014, Hengrui pharmaceutical and its holding subsidiary Shanghai Hengrui Pharmaceutical Co., Ltd submitted the clinical trial application to the provincial food and Drug Administration and was accepted In 2015, it obtained the CFDA's clinical trial approval In 2016, the supplementary application was again submitted to and accepted by the provincial food and drug administration Recently, CFDA agreed to increase the specifications of 1.0mg and 2.5mg during the clinical trial SHR4640 is an ideal selective inhibitor of URAT1, which is intended to be used in the treatment of hyperuricemia and gout Its positive control drug is lesinurad developed by Ardea Biosciences Inc, a subsidiary of AstraZeneca Lesinurad was approved by the US FDA on December 22, 2015 under the trade name of zurampuc ®, and approved by the EU on February 18, 2016 In 2016, the sales volume of lesinurad film in the U.S market was about USD 157000 According to the data query, only Ardea Biosciences Inc submitted an import clinical registration application for lesinurad tablets in China in October 2015 At present, no other APIs or preparations have been approved in China 3 Zhejiang Huahai Pharmaceutical Co., Ltd has approved the Anda application for duloxetine enteric coated capsule (the US generic application, which means the applicant can produce and sell the product in the US market) submitted to the US FDA This product is mainly used to treat depression and generalized anxiety disorder Duloxetine enteric coated capsules were developed by Eli Lilly and company and were launched in the United States in 2004 In the United States, the main manufacturers of duloxetine enteric coated capsules include citron, Teva, Lupin, etc.; the domestic manufacturers include Shanghai Zhongxi Pharmaceutical Co., Ltd and Eli Lily and company According to the sales data, the sales volume of the drug in the U.S market in 2016 is about 91 million US dollars, and the sales volume in the domestic market is about 349 million yuan.
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