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.
海普瑞(09989.HK):完成AR-301III期大中華區臨牀試驗首例患者給藥
格隆匯 06-23 20:10

格隆匯6月23日丨海普瑞(09989.HK)公吿,於2021年6月23日,旗下控股子公司深圳市瑞迪生物醫藥有限公司就AR-301作為抗生素輔助治療金黃色葡萄球菌引起的呼吸相關性肺炎(集團全人源單克隆抗體藥物)("AR-301-002")的III期大中華區藥品臨牀試驗已經完成首例患者給藥。這項大中華區關鍵性試驗預計將招募來自合共26個臨牀站點的30名患者。

名為AR-301-002的III期臨牀試驗為一項隨機、雙盲、安慰劑對照、多中心的臨牀研究,用於評價AR-301-002作為抗生素的聯合治療用於金黃色葡萄球菌性呼吸機相關性肺炎(VAP)治療的有效性和安全性。研究的主要臨牀有效性目標為評估第21天時單獨SOC治療與SOC和AR-301-002聯合治療間臨牀治癒率的差異。公司與領域內的臨牀專家一起定義了嚴格的臨牀治癒標準。

AR-301-002是特別針對金黃色葡萄球菌釋放的α毒素的全人源單克隆IgG1抗體(mAb),由公司參股子公司AridisPharmaceuticals,Inc.(一家於納斯達克上市(股份代號:ARDS)的公司)研發。該藥物通過與抗生素標準療法聯合用於治療金黃色葡萄球菌引發的呼吸系統相關性肺炎(VAP)患者。前期已經在美國完成的一項I/II期試驗的結果表明,與僅使用抗生素治療的患者相比,使用AR-301-002治療的患者一致被證實在機械通氣上耗時更少,根除金黃色葡萄球菌的比例更高。AR-301-002已獲得FDA授予的快速審評通道資格及EMA授予的孤兒藥資格。

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