基石藥業-B(02616.HK)：PD-L1抗體舒格利單抗治療成人R/R ENKTL獲美國FDA突破性療法認定
格隆匯 10 月 23日丨基石藥業-B(02616.HK)發佈公告，美國食品藥品監督管理局(“FDA”)授予其PD-L1抗體舒格利單抗(CS1001)治療成人復發或難治性結外自然殺傷細胞/T細胞淋巴瘤(“R/R ENKTL”)的突破性療法認定，這是繼10月份美國FDA授予PD-L1抗體舒格利單抗孤兒藥資格用於治療T細胞淋巴瘤之後，舒格利單抗取得的又一個重要進展。
突破性療法認定是一個新藥加快開發及審批的途徑，適用於治療嚴重或危及生命的疾病且初步臨牀證據顯示出顯着優於現有療法的藥品。舒格利單抗獲得突破性療法後將極大加快舒格利單抗在美國的開發及商業化速度。
結外自然殺傷細胞/T細胞淋巴瘤(“ENKTL”)屬於成熟T和NK細胞淋巴瘤的一個亞型。R/R ENKTL惡性程度高且侵襲性強，預後較差。R/R ENKTL患者在含門冬醯胺酶為基礎的標準方案失敗後，缺乏有效的挽救治療手段,對傳統治療反應不佳。臨牀醫生對於這類患者常常束手無策，因為疾病兇險，進展迅速，生存期極短，一年生存率不足20%。目前在中國獲批的靶向單藥治療完全緩解(“CR”)率約為6%。一線治療方案失敗後的患者正面臨着顯着的未被滿足的治療需求。在2020年中國臨牀腫瘤協會年會上，舒格利單抗單藥治療R/R ENKTL患者的CS1001-201研究牽頭研究者中山大學附屬腫瘤醫院黃慧強教授進行了口頭彙報。資料顯示，在38例療效可評估患者中，客觀緩解率(“ORR”)為44.7%，CR率為31.6%，中位緩解持續時間為16.8個月。接受給藥的43例患者，中位總生存期19.7個月，一年總生存率為55.5%。舒格利單抗有望為這些患者提供新的治療選擇。
基石藥業首席醫學官楊建新博士表示：“R/R ENKTL患者正面臨着顯着的未被滿足的治療需求，舒格利單抗相比現有藥物的療效資料是一個巨大的突破。此次舒格利單抗能夠獲得美國FDA突破性療法認定，充分證明了這款藥物的巨大臨牀價值。我們將繼續全力推進該研究，並與美國FDA和中國國家藥品監督管理局密切協作，力爭早日把舒格利單抗帶給全球R/R ENKTL患者。”
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.
