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.
舒泰神(300204.SZ)披露BDB-001注射液臨牀試驗相關進展
格隆匯 01-18 17:55

格隆匯 1 月 18日丨舒泰神(300204.SZ)公佈,近日,公司及全資子公司北京德豐瑞生物技術有限公司(德豐瑞)研發BDB-001注射液完成在新型冠狀病毒(2019-nCoV)感染患者中的安全性、耐受性、藥代動力學和藥效學Ib期臨牀研究和在健康受試者中單中心、隨機、雙盲、安慰劑對照的多劑量、單次、多次給藥的耐受性、藥代動力學Ic期臨牀試驗的臨牀研究報吿。

公司研發的BDB-001注射液於20200207日獲得國家藥品監督管理局簽發的批件號為2020L00003的《藥物臨牀試驗批件》,批准BDB-001注射液進行臨牀試驗。

本品的Ib期臨牀試驗是BDB-001注射液在新型冠狀病毒(2019-nCoV)感染患者中的安全性、耐受性、藥代動力學和藥效學臨牀研究。本試驗共計入組18例受試者,研究結果表明在試驗劑量範圍內,BDB-001注射液多次給藥具有良好的安全性和耐受性。

品的Ic期臨牀試驗旨在評價BDB-001注射液在健康受試者單次、多次給藥的耐受性藥代動力學特徵。本共計入組32例受試者研究結果表明在試驗劑量範圍內,BDB-001注射液單次給藥和多次給藥具有良好安全性和耐受性。BDB-001注射液單次給藥和多次給藥可以抑制健康人體內C5a水平,並且均未產生免疫原性。

截至20201216公司及全資子公司德豐瑞在西班牙、印度和印度尼西亞開展BDB-001注射液治療進展期重型COVID-19的國際多中心、開放、隨機平行對照的II/III期臨牀試驗,入組超過70例受試者。

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