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    Home > Medical News > Latest Medical News > Hengrui Medicine's remazolam tosylate for injection received the notice of drug supplement application approval

    Hengrui Medicine's remazolam tosylate for injection received the notice of drug supplement application approval

    • Last Update: 2021-10-11
    • Source: Internet
    • Author: User
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    On September 27, Hengrui Pharmaceuticals issued an announcement stating that the company received the approval of the State Food and Drug Administration for the "Drug Supplementary Application Approval Notice" for remazolam tosylate for injection, in the 36mg specification that has been approved for marketing [ On the basis of remazolam {C21H19BrN4O2}], a new 25mg specification [calculated as remazolam {C21H19BrN4O2}] is added
    .

    In December 2019, the company's 36mg remazolam tosylate for injection [calculated as remazolam {C21H19BrN4O2}] was approved by the National Food and Drug Administration for routine gastroscopy sedation; it was approved for use in June 2020 Sedation of colonoscopy
    .
    Remazolam tosylate for injection has a new 25mg specification [calculated as remazolam {C21H19BrN4O2}], which can be used for routine gastroscopy sedation and colonoscopy sedation, which increases the convenience of clinical use and reduces resources Waste

    .

    Remazolam tosylate belongs to the class of benzodiazepines and is a short-acting GABAa receptor agonist
    .
    Remazolam tosylate inhibits neuronal activity by binding to GABAa receptors, thereby producing a sedative effect

    .
    The advantages of remazolam tosylate are quick onset, short recovery time, and little impact on the respiratory and cardiovascular systems.
    In the phase III study of this product for gastroscopy and sedation, the remazolam tosylate group was affected The median sedation induction time of the subjects was 90 seconds, and the median recovery time from sedation was 6 minutes; the median sedation induction time of subjects in the remazolam tosylate group in the Phase III study for colonoscopy sedation It was 90 seconds and the median recovery time from sedation was 8 minutes.
    In the above-mentioned clinical trials, the incidence of hypotension in the remazolam tosylate group was 5.
    41% (24/444), and the incidence of bradycardia was 1.
    13% (5/444), the incidence of respiratory depression was 1.
    58% (7/444)

    .
    Therefore, this product is a relatively safe and controllable anesthesia/sedative drug

    .

    Remazolam besylate developed by PAIONAG, Germany, was approved for general anesthesia in Japan in January 2020, approved for procedural sedation in the United States in July 2020, and approved for listing in China in July 2020 Used for sedation during colonoscopy
    .

    Up to now, the total R&D expenses of remazolam tosylate for injection have been about 108.
    17 million yuan

    .

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