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.
和黃醫藥(00013.HK):完成賽沃替尼(savolitinib)用於治療胃癌的中國II期註冊研究的患者入組

格隆匯4月22日丨和黃醫藥(00013.HK)發佈公告,賽沃替尼用於治療MET擴增胃癌患者的II期研究的註冊階段已完成患者入組。該臨牀試驗是一項單臂、多中心、開放標籤的II期註冊研究,旨在評估賽沃替尼用於治療伴有MET擴增的胃癌和胃食管結合部(GEJ)腺癌的療效、安全性和耐受性。研究的主要終點爲獨立審查委員會(IRC)評估的客觀緩解率(“ORR”)(依據RECIST 1.1進行評估) 。次要終點包括無進展生存期(PFS) 、各種不良事件的發生率等。

於美國癌症研究協會(AACR)年會上公佈的該研究的中期分析結果顯示,經獨立審查委員會確認的ORR爲45%,而在高MET基因拷貝數的患者中ORR爲50% 。4個月時的緩解持續時間率爲85.7% ,中位隨訪時間爲5.5個月。最常見的3級或以上治療相關不良事件(TRAE)(發生率超過5%)爲血小板數量降低、過敏、貧血、中性粒細胞減少及肝功能異常。只有1名患者因4級肝功能異常(治療相關不良事件)停止治療,沒有患者因治療相關不良事件死亡。

中國國家藥品監督管理局(“國家藥監局”)已將賽沃替尼納入突破性治療藥物品種,用於治療既往接受過至少兩線標準療法失敗的MET擴增的局部晚期或轉移性胃癌或胃食管結合部(GEJ)腺癌患者。如果研究取得積極結果,和黃醫藥有望於2025年年底在中國啓動向國家藥監局遞交賽沃替尼用於治療胃癌的上市許可申請。 

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