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.
四環醫藥(00460.HK):軒竹生物自研創新藥地羅阿克片獲國家藥監局上市批準

格隆匯8月22日丨四環醫藥(00460.HK)發佈公告,集團旗下非全資附屬公司軒竹生物科技股份有限公司自主研發的ALK抑制劑1類創新藥地羅阿克片(曾用名「達希替尼」,XZP-3621,商品名:軒菲寧)獲得中國國家藥品監督管理局(NMPA)批準上市,用於治療間變性淋巴瘤激酶(ALK)陽性的晚期非小細胞肺癌(NSCLC)。該產品是軒竹生物第三個獲批上市的1類創新藥,同時也是軒竹生物第二個獲批上市的1類創新腫瘤藥,標誌着其腫瘤領域研發完成從乳腺癌到肺癌靶向治療的持續跨越。

地羅阿克具有四大核心優勢,包括(1)起效迅速:地羅阿克通過獨特的分子結構設計,顯著提升了藥物的生物利用度,能夠快速抑制腫瘤進展,爲患者爭取關鍵治療窗口。(2)抑瘤強度卓越:在關鍵Ⅲ期臨牀試驗中,地羅阿克治療ALK陽性晚期NSCLC患者顯著優於已上市一代及二代ALK抑制劑,且對包括G1202R、I1171N在內的耐藥突變表現出強效抑制活性。(3)緩解持久:患者獲益時間顯著延長,爲長期疾病穩定奠定基礎。(4)生存獲益顯著:真正實現了「慢性病管理」的目標。

此外,地羅阿克成功破解了臨牀難題,實現了腦轉移控制與安全性的雙重突破。其高效穿透血腦屏障,有效彌補了現有療法在中樞神經保護方面的不足。在安全性方面,地羅阿克表現出顯著優勢,不良反應主要表現爲腹瀉、嘔吐等消化道反應,且多爲1~2級,通過對症治療和╱或劑量調整即可緩解或痊癒。此外,胸腔積液、肝毒性等風險顯着降低,顯著提升了患者的長期用藥依從性。

地羅阿克此次獲批上市,不僅是軒竹生物創新藥管線的重要研發里程碑,同時也爲我國ALK陽性非小細胞肺癌患者提供了突破性治療選擇,憑藉其顯著的臨牀優勢,將切實改善患者生存品質,助力「健康中國2030」癌症防治目標的加速實現。

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