和黃醫藥啟動治療轉移性結直腸癌新藥國際三期期臨床試驗FRESCO-2
和黃醫藥(HCM.US)公布,在美國、歐洲和日本啟動了一項(口夫)(口奎)替尼治療轉移性結直腸癌患者的三期註冊研究FRESCO-2。首名患者已於昨日(3日)在美國接受給藥治療。
公司指,FRESCO-2是一項在轉移性結直腸癌患者中開展的隨機、雙盲、安慰劑對照的多中心臨床試驗。研究的主要終點是總生存期。該項大型三期臨床試驗計劃於10個國家的約130個研究中心開展患者招募。美國食品藥品監督管理局(FDA)於今年6月授予(口夫)(口奎)替尼快速通道資格,開發用於治療轉移性結直腸癌患者。
根據公司與FDA達成的協議,(口夫)(口奎)替尼的臨床數據將可用於支持(口夫)(口奎)替尼用於治療三線或以上轉移性結直腸癌患者的新藥上市申請。FRESCO-2的研究設計亦已通過歐洲藥品管理局與日本醫藥品和醫療器械局的審閱及認可。
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.