衆生藥業(002317.SZ):昂拉地韋片獲得國家藥品監督管理局批準上市
格隆匯5月22日丨衆生藥業(002317.SZ)公佈,2025年5月22日,國家藥品監督管理局網站發佈了《國家藥監局批準昂拉地韋片上市》的通知,廣東衆生藥業股份有限公司控股子公司廣東衆生睿創生物科技有限公司(簡稱“衆生睿創”)自主研發的一類創新藥物昂拉地韋片(商品名:安睿威®,研發代號:ZSP1273)獲得國家藥監局批準上市。昂拉地韋片是具有明確作用機制和全球自主知識產權的全球首款流感RNA聚合酶PB2蛋白抑制劑,適用於成人單純性甲型流感患者的治療。
昂拉地韋片III期臨牀試驗結果提示,與安慰劑組相比,昂拉地韋組在主要終點指標七項流感症狀緩解時間(TTAS)、次要終點指標包括單系統或單症狀指標緩解時間、病毒學指標(如病毒載量下降、病毒轉陰時間、病毒轉陰受試者比例)等均優於安慰劑組,達到統計學顯著性差異。昂拉地韋片也是國內唯一一個與奧司他韋頭對頭開展III期臨牀試驗並獲批上市的抗流感藥物,昂拉地韋組在中位TTAS和發熱緩解時間均比奧司他韋組縮短了近10%。
體外病毒學研究表明,昂拉地韋對多種甲型流感病毒的抑制能力顯著優於神經氨酸酶抑制劑奧司他韋以及核酸內切酶抑制劑瑪巴洛沙韋,並且對於奧司他韋耐藥的病毒株、瑪巴洛沙韋耐藥的病毒株和高致病性禽流感病毒株均具有很強的抑制作用。
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.