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.
遠大醫藥(00512.HK):集團全球創新放射性產品SIR-Spheres®釔[90Y]微球注射液提前正式獲得FDA批準新增適應症

格隆匯7月7日丨遠大醫藥(00512.HK)公告,集團聯營公司Sirtex Medical Pty Ltd的SIR-Spheres®釔[90Y]微球注射液近日獲得美國食品藥品監督管理局("FDA")正式批準新增適應症,用於治療不可切除肝細胞癌。

此次提前正式獲批是基於DOORwaY90臨牀試驗的突破性中期數據成功達到預設的共同主要終點,標誌着SIR-Spheres®釔[90Y]微球注射液成爲全球首個且唯一獲FDA批準用於不可切除HCC和結直腸癌肝轉移雙重適應症的選擇性內放射治療產品,相關臨牀數據也將爲中國適應症拓展提供有力支援;同時,彰顯了集團優秀的海外臨牀註冊能力,爲後續自研創新核藥產品的海外開發工作提供重要保障。集團始終重視研發創新,依託核藥全球化佈局及自主可控的產業生態,已構建覆蓋診斷治療一體化、國內國際雙循環的核醫學創新矩陣,形成"研發-生產-銷售"全產業鏈閉環體系。

未來,集團將持續推進核藥抗腫瘤診療產品的全球拓展及商業化進程,鞏固全球行業領先地位。

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