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    Home > Medical News > Medical Research Articles > Enkephalin, a new and important drug in Hanyu pharmaceutical industry, entered the site for inspection

    Enkephalin, a new and important drug in Hanyu pharmaceutical industry, entered the site for inspection

    • Last Update: 2020-04-03
    • Source: Internet
    • Author: User
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    According to the website of the State Food and Drug Administration (CFDA) on May 21, Hanyu Pharmaceutical Co., Ltd has launched on-site inspection of new drugs such as enkephalin and enkephalin injection, which means that the nine-year-old application of new drugs has finally come to an end Hanyu pharmaceutical declared the clinical approval documents of enkephalin API and injection in October 2005, and was approved to carry out clinical trials in July 2006; it declared production in March 2010, and has been required to submit technical supplementary data twice so far, and the approval time of the products has been correspondingly delayed In April this year, enkephalin was allowed to enter the on-site inspection After a short period of one month, enkephalin quickly entered the on-site inspection status The marathon approval trip is about to end At the beginning of the year, company executives said on various occasions that the blockbuster new drug would be approved within this year Enkephalin injection has the function of anti platelet aggregation It was first launched in the United States in 1998, and its sales amount in the United States in 2007 reached 332 million US dollars As early as October 2012, etibatide for injection with the same variety but different common name was first imitated by Jiangsu Haosen Pharmaceutical Co., Ltd because of its good efficacy and potential huge market, it was rated as "China's top ten heavyweight prescription drugs in 2012" by many pharmaceutical authorities Previously, the company's executives have said that enkephalin is a PCI (coronary intervention) surgical drug, with a large market, and it is expected to catch up with the bidding work in various provinces after listing Combined with the company's Hospital advantages in the peptide field, the market size of enkephalin may reach one billion yuan At present, only Hanyu pharmaceutical and Qilu pharmaceutical have applied for enkephalin in China, while etibatin has been applied by Shuangcheng pharmaceutical, an old competitor Last year, Shuangcheng pharmaceutical withdrew its application for registration, redone clinical re application, and the review progress slowed down The existing peptide drugs of Hanyu pharmaceutical industry include thymopentin for injection, somatostatin for injection, deammopressin acetate injection and terlipressin for injection In addition to enkephalin injection, the new heavyweight polypeptide products under research also include new drugs such as carbetoxine, atroxaban acetate injection, cetrix for injection, etc., and are also applying for production approval According to the public information, by 2012, the overall sales scale of China's chemical synthetic peptide drug market has exceeded 10 billion yuan  
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