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.
百濟神州(BGNE.US/06160.HK)百澤安第5個適應症遞交,即將開拓肝細胞癌領域
格隆匯 07-02 10:28

百濟神州(BGNE.US/06160.HK)是一家處於商業階段的生物科技公司,專注於用於癌症治療的創新型分子靶向和腫瘤免疫藥物的開發和商業化。公司於北京時間2020年7月2日宣佈國家藥品監督管理局(NMPA)藥品審評中心(CDE)已受理其抗PD-1抗體藥物百澤安(替雷利珠單抗注射液)用於治療既往接受過治療的不可切除肝細胞癌(HCC)患者的新適應症上市申請(sNDA)。

百濟神州中國區總經理兼公司總裁吳曉濱博士表示:“百澤安針對肝癌的首項申請被受理讓我們感到振奮。目前全世界有一半的肝癌患者在中國,這意味着有大量未被滿足的醫療需求。我們期待與藥品審評中心保持溝通,希望在不久的將來為這些患者帶來一項行之有效的治療方案。”

此項sNDA是基於百澤安用於治療既往接受過治療的不可切除HCC患者的關鍵2期臨牀試驗(NCT03419897)結果。該試驗入組了來自亞洲和歐洲的8個國家和地區共249例不可切除HCC患者,其中138例患者既往接受過一項全身系統療法,111例患者既往接受過至少兩項療法。患者接受了百澤安每三週一次、每次劑量為200mg 的治療。該試驗的主要終點為經獨立評審委員會(IRC)評估的客觀緩解率(ORR)。試驗結果將在未來一場醫學會議上被公佈。

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 this article is for reference only. It does not constitute an offer, solicitation, recommendation, opinion or guarantee of any securities, financial products or instruments.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.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance.
uSMART
Wealth Growth Made Easy
Open Account