You are browsing the Hong Kong website, Regulated by Hong Kong SFC (CE number: BJA907). Investment is risky and you must be cautious when entering the market.
海思科(002653.SZ):創新藥注射用HSK36273臨牀試驗申請獲受理
格隆匯 01-17 16:46

格隆匯1月17日丨海思科(002653.SZ)公佈,公司於近日收到國家藥監局下發的關於注射用HSK36273(125mg)的《受理通知書》。受理號為CXHL2200011,申請事項為境內生產藥品註冊臨牀試驗。

注射用HSK36273系公司前期引進的靜脈用抗凝血藥物EP7041,海思科擁有其在中國內地的獨家許可,臨牀擬用於血液透析及術中患者的全身抗凝。根據《國家藥監局關於發佈化學藥品註冊分類及申報資料要求的通吿(2020年第44號)》中化學藥品新註冊分類的規定,該藥品屬於化學藥品1類。

血液透析是急性和慢性腎功能衰竭的治療手段之一。在透析治療時,患者血液需要經過體外循環迴路,在這個過程中,凝血過程會被激活。體外循環迴路和透析膜上的血栓積累會大大降低透析的效率、增加費用和導致患者血液的損失。血栓形成也是手術併發症之一,對術後恢復有重要影響。因此在很多手術中,均需要對患者進行全身抗凝,以防止圍手術期的血栓生成。

目前臨牀常用於抗凝治療的藥物主要包括維生素K拮抗劑、肝素、小分子肝素、凝血因子Xa抑制劑、直接凝血酶抑制劑和溶栓劑。這些藥物在減少血栓形成的同時,依然存在出血的安全性問題,且都與內出血(特別是顱內、胃腸道和腹膜後出血)等危及生命的副作用有關。

HSK36273為新型抗凝血藥物,僅作用於內源性凝血途徑,有望解決臨牀抗凝治療中的出血問題。前期研究表明,療效與肝素相當,但安全性大大提高,其成功開發具有重要的臨牀和社會意義。

Follow us
Find us on Facebook, Twitter , Instagram, and YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app!
Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.
uSMART
Wealth Growth Made Easy
Open Account