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.
諾泰生物(688076.SH):英克司蘭原料藥取得FDADMF備案號
格隆匯 04-17 16:53

格隆匯4月17日丨諾泰生物(688076.SH)公佈,控股子公司杭州諾泰諾和生物醫藥科技有限公司收到美國食品藥品監督管理局(簡稱“FDA”)關於英克司蘭(Inclisiran)原料藥的DMF回執,公司英克司蘭原料藥順利取得DMF備案號。英克司蘭是一種siRNA長效降脂藥物,可降解肝臟中PCSK9的信使核糖核酸(mRNA),阻斷PCSK9蛋白合成,從而降低循環中LDL-C水平。最初於2021年12月獲得美國FDA批准,作為飲食和他汀類藥物治療的輔助藥物,用於治療患有原發性高脂血症的成年患者,包括雜合子型家族性高膽固醇血癥(HeFH)患者,以降低其LDL-C的水平。目前已在包括中國在內的多個國家獲批該適應症。

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