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.
君實生物(01877.HK)收到特瑞普利單抗注射液上市申請《受理通知書》
格隆匯 04-29 18:55

格隆匯4月29日丨君實生物-B(01877.HK)發佈公告,公司及子公司蘇州眾合生物醫藥科技有限公司於近日收到國家藥品監督管理局簽發的特瑞普利單抗注射液(商品名:拓益*,產品代號:JS001)用於治療既往接受過二線及以上系統治療失敗的復發╱轉移鼻咽癌的新適應症上市申請《受理通知書》。

根據披露,鼻咽癌多發於我國南方、東南亞等地區,POLARIS-02研究(NCT02915432)為一項多中心、開放標籤、II期關鍵註冊臨牀研究,旨在評估特瑞普利單抗對既往接受系統治療失敗的復發╱轉移性鼻咽癌患者的有效性和安全性。本次新適應症上市申請是全球首個抗PD-1單抗治療復發╱轉移鼻咽癌的新藥上市申請。

除此之外,特瑞普利單抗注射液聯合化療作為復發或轉移性鼻咽癌患者一線治療方案的三期臨牀研究JUPITER-02研究(NCT03581786)入組已完成。 

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