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.
恒瑞醫藥(600276.SH):Edralbrutinib片用於治療視神經脊髓炎譜系疾病適應症獲美國FDA孤兒藥資格認定
格隆匯 05-07 17:00

格隆匯5月7日丨恒瑞醫藥(600276.SH)公佈,近日,公司子公司瑞石生物醫藥有限公司(“瑞石生物”)產品Edralbrutinib片用於治療視神經脊髓炎譜系疾病(NMOSD)適應症獲得美國食品藥品監督管理局(“美國FDA”)授予的孤兒藥資格認定。孤兒藥又稱罕見病藥,是指用於預防、治療、診斷罕見病的藥品。此次瑞石生物獲得美國FDA孤兒藥資格認定,將有機會在產品研發、註冊及商業化等方面享受美國的政策支持。

此次Edralbrutinib片用於視神經脊髓炎適應症獲得孤兒藥資格認定後,能夠加快推進臨牀試驗及上市註冊的進度。同時,可享受一定的政策支持,包括但不限於臨牀試驗費用的税收抵免、免除新藥申請費、產品獲批後將享受7年的市場獨佔權。

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