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.
康諾亞-B(02162.HK):CM310治療慢性鼻竇炎伴鼻息肉的III期臨牀試驗達到主要終點
格隆匯 12-27 08:22

格隆匯12月27日丨康諾亞-B(02162.HK)發佈公吿,其1類新藥CM310重組人源化單克隆抗體(司普奇拜單抗)注射液治療慢性鼻竇炎伴鼻息肉的III期臨牀研究(CM310-102208,登記號: CTR20221480)已完成雙盲治療期數據揭盲及初步統計分析,臨牀數據達到主要終點。

CM310-102208是一項多中心、隨機、雙盲、安慰劑對照的III期臨牀研究,主要用於確證CM310重組人源化單克隆抗體注射液在治療慢性鼻竇炎伴鼻息肉患者中的有效性及安全性。本次研究共納入了180例受試者,以1:1的隨機比例分別接受 CM310 300mg和安慰劑治療,每2週一次,雙盲期共治療12次,共同主要終點是治療24周鼻息肉評分(NPS)及鼻塞評分(NCS)較基線變化。研究結果顯示III期臨牀試驗數據結果積極,共同主要終點均完全達標,CM310組皆優於安慰劑組,具備高度顯著的統計學差異(P值均<0.0001),且安全性良好。公司計劃將於2024年內向國家藥品監督管理局(NMPA)藥品評審中心(CDE)遞交CM310治療慢性鼻竇炎伴鼻息肉的上市許可申請。

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