和黃醫藥(00013.HK)與信達生物宣佈呋喹替尼(fruquintinib)聯合信迪利單抗(sintilimab)用於治療晚期子宮內膜癌的中國新藥上市申請獲受理並獲納入優先審評
格隆匯4月2日丨和黃醫藥(00013.HK)與信達生物今日聯合宣佈呋喹替尼與信迪利單抗的聯合療法用於治療既往系統性抗腫瘤治療後疾病進展且不適合進行根治性手術治療或根治性放療的晚期錯配修復完整(pMMR1)或非微衞星高度不穩定(非 MSI-H2)的子宮內膜癌患者的新藥上市申請已獲中國國家藥品監督管理局("國家藥監局")受理並予以優先審評。
FRUSICA-1 研究的數據支持了此項新藥上市申請。FRUSICA-1 是一項多中心、開放標籤的 II 期臨牀試驗的子宮內膜癌註冊隊列,旨在評估呋喹替尼聯合信迪利單抗治療含鉑雙藥化療治療後疾病復發、疾病進展或出現不可耐受的毒性的子宮內膜癌患者。研究的主要終點是獨立審查委員會(IRC)評估的客觀緩解率(ORR),次要終點包括疾病控制率(DCR)、緩解持續時間(DoR)、無進展生存期(PFS)、總生存期(OS)和藥代動力學評估。FRUSICA-1研究的數據將提交於近期的學術會議上發表。該項研究的其他詳情可登錄 clinicaltrials.gov,檢索註冊號NCT03903705 查看。
和黃醫藥研發負責人及首席醫學官石明博士表示:"這是呋喹替尼和免疫檢查點抑制劑信迪利單抗聯合療法的首個監管註冊申請。 這也標誌着在中國我們在改寫這種具有挑戰性的疾病的治療格局的道路上又邁出了重要的一步。子宮內膜癌仍然是最常見的婦科惡性腫瘤之一。我們期待為子宮內膜癌患者帶來這一翹首以盼的治療進展,以改善他們的治療結果。"
信達生物高級副總裁周輝博士表示:"達伯舒® (信迪利單抗注射液)作為免疫腫瘤領域的基石療法,與抗血管生成藥物聯合使用,有望改善中國子宮內膜癌患者的預後。我們對新藥上市申請獲受理並予以優先審評感到興奮,這增加了我們為子宮內膜癌患者帶來新的治療選擇的潛力,同時也將鞏固達伯舒®在中國的領導地位。"
呋喹替尼與信迪利單抗的聯合療法於 2023 年 7 月獲國家藥監局納入突破性治療品種用於此項潛在適應症。國家藥監局將該聯合療法納入突破性治療品種,作為用於防治嚴重危及生命的疾病,且尚無有效防治手段或與現有治療手段相比具有明顯臨牀優勢的創新藥物。
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.