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.
藥明生物(02269.HK)祝賀Tychan全球首個黃熱病單抗人體研究初證安全有效
格隆匯 11-19 08:56

原創: WuXi Biologic

全球領先的開放式生物製藥技術平台公司藥明生物(02269.HK)的合作伙伴Tychan公司近日宣佈在新加坡成功完成全球首個黃熱病單克隆抗體候選藥物TY014的IA/IB期安全性和有效性臨牀試驗,藥明生物對此表示祝賀。

在藥明生物一體化生物製藥技術平台賦能下,TY014從項目啟動到申請新藥臨牀試驗(IND)僅歷時7個月。Tychan與藥明生物間的緊密合作加快了安全、有效治療方法的上市進程,將在抵禦新發傳染病大流行方面發揮至關重要的作用。

Tychan公司董事會主席Teo Ming Kian先生説:“此次臨牀試驗結果為全球首個基於單抗的黃熱病治療方法上市奠定了堅實基礎,也是繼寨卡病毒單抗人體安全研究成功後再次驗證了Tychan和藥明生物的創新合作模式。雙方的創新合作模式顯著加速生物藥開發進程,將有效應對新發傳染病暴發,並可能最終擴展應用至更多治療領域。

“祝賀Tychan全球首個黃熱病單抗TY014實現又一重大里程碑,我們非常榮幸通過藥明生物一體化生物製藥技術平台賦能Tychan,以全球最高質量標準加快TY014從DNA到臨牀試驗的進程。”藥明生物首席執行官陳智勝博士表示,“藥明生物憑藉強大的專業知識與能力,以及充足的全球產能儲備,持續加速創新生物藥研發和生產進程,賦能全球合作伙伴開發出更多拯救生命的創新治療方法,造福廣大患者。

關於TY014

TY014是全球首個進入臨牀階段的針對治療黃熱病毒感染者而設計和製造的單克隆抗體,直接作用於病毒表面的包膜E蛋白,通過限制病毒整合到宿主細胞中來阻止病毒複製。

關於TY014 IA/IB期臨牀試驗

TY014第一部分人體臨牀試驗在新加坡大約27名健康志願者中進行。參與I期臨牀試驗的志願者被分隨機分為兩組,每組包括五個劑量組,每個劑量組接受TY014或安慰劑,研究主要終點為安全性和耐受性,次要終點包括藥代動力學和免疫原性。在第二部分臨牀試驗中,志願者在接受TY014或安慰劑之前接種黃熱病減毒活疫苗,治療組的研究終點包括安全性、耐受性以及病毒血症。

臨牀試驗結果顯示,TY014不僅在最高劑量試驗中具有良好的安全性和耐受性,而且還具有抑制疫苗病毒和相關不良反應的作用。本試驗由新加坡中央醫院傳染病學系高級顧問、ViREMiCS聯席主任Jenny Low副教授主持。

關於Tychan

Tychan是一家新加坡臨牀階段生物技術公司,專注於應用顛覆性技術為新發傳染病患者帶來拯救生命的療法。在與監管機構的積極協調下,公司正在加速推動新發病原體臨牀前研究轉化至臨牀研究。Tychan由麻省理工學院和SMART的教授Ram Sasisekharan博士、杜克-新加坡國立大學教授Ooi Eng Eong博士共同創立,他們分別是生物製藥研發和急性病毒感染生物學領域的權威專家,淡馬錫控股公司則是Tychan的創始投資人。

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