Awesome! Haisco's first application for new narcotic drug to be marketed accepted
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Last Update: 2020-06-02
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Source: Internet
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Author: User
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Pharmaceutical Network August 2, July 31, Haisco announced that the company and its wholly-owned subsidiaries Sichuan Haisco Pharmaceutical Co., Ltd., Liaoning Haisco Pharmaceutical Co., Ltdon July 30, 2019 received the State Drug Administration issued a "notice of acceptance", intravenous anesthesia new drug HSK3486 emulsion injection application was acceptedThe basic situation of the drugHSK3486 emulsion injection is a new intravenous anaesthetic drug with independent intellectual property rights developed by Hesco, which is intended to be used for surgical all-hemp induction, endoscopic sedation/anaesthetic, ICU sedation and other indicationsAccording to theclassification provisions of the new chemicaldrug registration in China, the registration of drugs is classified as the chemical drug category 1HSK3486 was approved for a clinical trial of drugs in January 2016, initiated a clinical trial of "digestion endoscopic diagnosis and treatment of sedative/anaesthetic" indications, and has now completed Phase III clinical trials and data cleanup, and the application for new drugs (special approval procedure) was accepted by the State Drug Administration on July 29, 2019In addition, Phase III clinical trials of anaesthetic induction indications are under way in ChinaThe clinical situation of HSK3486 emulsion injections into date, the company has invested about 191 million yuan in research and development of HSK3486 emulsion injectionsHesco said that the acceptance of HSK3486 emulsion injection marks a milestone in the company's research and development of innovative drugs, has accumulated valuable experience in the development of innovative drugs, if successfully approved will be the company's first successful research and development of innovative drugsdata source: Internet database, company announcement
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