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    Home > Active Ingredient News > Digestive System Information > Hesco's new Class 1 drug, Cyclophenol, has been approved for sale

    Hesco's new Class 1 drug, Cyclophenol, has been approved for sale

    • Last Update: 2021-01-06
    • Source: Internet
    • Author: User
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    On December 14, NMPA's official website revealed that the New Class 1 drug HSK3486 Emulsion (Cyclophenol) from Liaoning Haisco was approved for the diagnosis and treatment of sedation and/or anesthesia in the digestive tract endoscopy.
    HSK3486 (i.e., cyclophenols, the commodity named Sisshuning) is an innovative class 1.1 drug developed by Hesco with fully independent intellectual property rights, and is also the first intravenous anesthetic to innovate its own compounds in China.
    the drug is an improved new drug of the classic anaesthetic sedative propofol, which is significantly more effective than propofol and is more safe than propofol.
    In Phase II, head-to-head clinical trial results showed that the dose of 0.4-0.5 mg/kg was essentially consistent with the sedative effect of propofol at 2 mg/kg (anaesthetic success rate, effectiveness, and wake-up time).
    safety, HSK3486 is a significant improvement over propofol, with statistics showing that the rate of injection pain decreased to one-fifth (9.5% vs. 45.2%), while respiratory inhibitory side effects were significantly reduced (11.1% vs 16.1%).
    according to insight database, HSK3486 currently registers 20 Phase I-III clinical studies in china, of which 16 have been completed and 4 are ongoing, and adaptations include painless endoscopy sedation and/or anesthesia (NDA declaration), general anaesthetic induction (NDA declaration), sedation and/or anesthesia (Phase III), General Anaesthetic induction and maintenance (Phase III), ICU sedation (Phase III), etc.
    from the Insight database (), where applications for general anaesthetic-induced adaptation of the drug were accepted by the CDE in January this year (the relevant acceptance number is CXHS2000001) and included in the priority review.
    HSK3486's benchmark product, propofol, is an ace in the field of intravenous anesthesia sedation.
    the drug has dominated the field of injectable anaesthetic static drugs since it was approved for market by the FDA in 1989, thanks largely to its excellent drug metabolic dynamics and good safety.
    Relatively competing in the same field, propofol is the most widely used intravenous anesthetic sedative with a fast effect, short wake-up time, and virtually no side effects such as nausea and vomiting after waking up, according to IQVIA data, the global base consumption of propofol in 2017 exceeded 300 million units (in 200 mg specifications).
    propofol is a high-fat soluble drug, does not meet the needs of clinical intravenous administration, the current clinical use of propofol injections are two kinds, namely propofol emulsion (containing long-chain glycelin three lipids) and propofol medium/long-chain fat emulsion injection (containing medium) / Long-chain triglycerides), wherein propofol medium/long-chain fat emulsion replaces long-chain triglycerides with partial chain triglycerides as a new carrier, further increasing solubility, reducing free propofol content, and medium chain triglyceride metabolism is faster.
    , clinical use can effectively reduce injection pain, reduce the risk of hyperlipidemia, reduce the burden on the liver.
    Insight database shows that at present, a number of domestic enterprises have obtained propofol injection production batch (see table below), of which only Jiangsu Yingke Biopharmaceuticals and Sichuan Colum Pharmaceuticals propofol medium / long chain fat milk injection through a consistent evaluation.
    it is known that domestic sales of propofol emulsions and propofol medium/long-chain fat emulsions in 2019 were RMB 3.672 billion and RMB 1.95 billion, respectively, of which the market for propofol medium/long-chain fat emulsions was mainly occupied by Fessenyuskabi.
    HSK3486 as a me-better product of propofol, Hesco estimates that its domestic market size is expected to exceed 3 billion yuan.
    approved for the market and is expected to have an impact on the existing market for propofol.
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