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.
亞盛醫藥(06855.HK)原創新藥獲孤兒藥資格認定
阿思達克 07-22 03:54
亞盛醫藥-B(06855.HK)公佈,美國食品和藥品監督管理局(FDA)日前授予公司細胞凋亡管線在研原創新藥MDM2-p53抑制劑APG-115孤兒藥資格認定,用於治療IIB-IV期黑色素瘤。這是APG115繼胃癌、急性髓系白血病、軟組織肉瘤、視網膜母細胞瘤後,獲得的第五項FDA授予的孤兒藥資格認定。至今,公司共有4個在研新藥獲得12項FDA孤兒藥認定。

「孤兒藥」又稱爲罕見藥,指用於預防、治療、診斷罕見病的藥品。本次獲得美國FDA授予的孤兒藥資格認定,將有助於該藥物在美國的後續研發及商業化開展等方面享受一定的政策支持,包括享有臨牀試驗費用稅收減免、免除NDA申請費用、獲得研發資助等,特別是批準上市後可獲得美國市場七年獨佔權。

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