亞盛醫藥-B(06855.HK)：APG-115在中國獲批一項Ib/II期臨牀試驗
格隆匯 10 月 27日丨亞盛醫藥-B(06855.HK)發佈公告，公司1類新藥MDM2-p53抑制劑APG-115獲得國家藥品監督管理局藥物審評中心(CDE)臨牀許可，將開展聯合PD-1/PD-L1抑制劑治療晚期脂肪肉瘤或其他晚期實體瘤患者的Ib/II期臨牀研究。
該項研究為針對晚期脂肪肉瘤或其他晚期實體瘤患者進行的全國多中心、開放性、聯合治療的Ib/II期研究，將分成兩個階段進行，Ib期為劑量探索階段，旨在評估APG-115聯合PD-1抑制劑(特瑞普利單抗)的安全性和耐受性；II期為劑量擴增，並在TP53野生型且MDM2擴增的晚期脂肪肉瘤患者中探索療效。
脂肪肉瘤(LPS)是軟組織肉瘤中常見的組織學類型，約佔軟組織肉瘤的20%，MDM2擴增在脂肪肉瘤中常見，同時脂肪肉瘤患者TP53為野生型者約佔一半。手術切除是當前脂肪肉瘤治療的主要手段，也推薦術前、術後化療加或不加放療。晚期復發或轉移性中LPS患者也可接受全身化療。然而根據目前的數據晚期脂肪肉瘤在化療中的獲益極小，超過80%的脂肪肉瘤病例均會復發。目前可用於脂肪肉瘤的靶向治療及免疫治療的藥物及療效均非常有限。因此，全面瞭解脂肪肉瘤的病理特點，探索並開發新型、有效的針對脂肪肉瘤的聯合治療方案，是亟待解決的臨牀問題。
APG-115是亞盛醫藥自主研發的一種口服生物可利用的、高選擇性的小分子MDM2抑制劑。APG-115對MDM2具有高度結合親和力，通過阻斷MDM2-p53蛋白質間相互作用從而恢復p53腫瘤抑制活性。APG-115是首個在中國進入臨牀階段的MDM2-p53抑制劑，已在中國和美國展開多項治療實體瘤及血液腫瘤的臨牀研究。值得關注的是，APG-115在中國單藥治療晚期脂肪肉瘤的臨牀研究中已顯示出積極的抗腫瘤效果。一例部分緩解(PR)患者停藥後觀察到的超過10個月的持續緩解，顯示APG-115可能具有宿主免疫調節作用，也為進一步評價APG-115單藥治療或與免疫治療聯合治療提供了基礎。
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.
