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.
前沿生物(688221.SH):新冠候選新藥FB2001在美啟動I期臨牀試驗
格隆匯 05-25 18:19

格隆匯5月25日丨前沿生物(688221.SH)公佈,公司與中國科學院上海藥物研究所達成合作,公司獲得新冠肺炎病毒(SARS-CoV-2)候選新藥FB2001(DC系列候選藥物)在全球範圍內的臨牀開發、生產、製造及商業化權利。

FB2001候選藥物中,DC402234是基於冠狀病毒主蛋白酶三維結構設計合成的擬肽類化合物,對新冠肺炎病毒SARS-CoV-2 Mᵖʳᵒ的抑制活性IC₅₀為0.053±0.005μM,體外抗病毒活性EC₅₀為0.42±0.08μM,具有高效靶向冠狀病毒主蛋白酶的活性,同時在實驗動物體內展現出良好的體內藥代動力學性質和安全性。上述研究成果已發表於國際權威期刊《科學》(Science)並作為封面文章刊登。

2020年,FB2001完成了原料藥和製劑的工藝、質量及藥理毒理研究工作,並向美國FDA提交了IND申請。

目前,FB2001已獲得美國FDA核准簽發的臨牀試驗批件,並在美國啟動了FB2001的I期臨牀試驗,採用單中心、隨機、盲法、對照設計,主要目的為評價本品在人體的耐受性、安全性和藥代動力學特徵。

截至2021年4月28日,受試者已經入組,並完成第一劑量組給藥,經獨立數據安全委員會研究,第一劑量組安全性良好,建議繼續開展劑量遞增研究。

截至該公吿披露日,公司已開展相關研究。

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