IL-6靶點迎新戰局：諾華重金入局心血管領域

DoNews

2025/09/24

IL-6作為自免疾病的重要靶點已取得顯著成功，全球已有4款靶向IL-6/IL-6R的藥物獲批上市。首款IL-6R單抗託珠單抗憑藉先發優勢和多項適應症長期佔據市場主導地位，並在2021年因獲FDA緊急授權用於重症新冠治療，銷售額達到39.6億美元峯值。隨着託珠單抗專利到期，生物類似藥陸續進入市場，競爭加劇。藥企紛紛轉向差異化佈局，拓展IL-6抑制劑在風溼病以外的新適應症。IL-6作為一種多效性...

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href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250924111222a69a4653&s=b\">網頁鏈接</a>\n\n</div>\n\n<div class=\"bt-text\">\n\n\n<p> 來源：<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250924111222a69a4653&s=b\">DoNews</a></p>\n<p>為提升您的閱讀體驗，我們對本頁面進行了排版優化</p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"IE00B2B36J28.USD","symbol_name":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I1\" (USD) INC","start_time":0,"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250924111222a69a4653&s=b","article_id":"2569272913","we_media_id":null,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250924111222a69a4653&s=b","rn_cache_url":null,"customStyle":"body{padding-top:10px;}#news_title{font-weight:bold;#titleStyle#;}#news_description 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welcomes the new battle situation: Novartis invests heavily in the cardiovascular field","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"NVO":0.9,"NVS":1.5,"PFE":0.9},"content_text":"IL-6作為自免疾病的重要靶點已取得顯著成功，全球已有4款靶向IL-6/IL-6R的藥物獲批上市。首款IL-6R單抗託珠單抗憑藉先發優勢和多項適應症長期佔據市場主導地位，並在2021年因獲FDA緊急授權用於重症新冠治療，銷售額達到39.6億美元峯值。隨着託珠單抗專利到期，生物類似藥陸續進入市場，競爭加劇。藥企紛紛轉向差異化佈局，拓展IL-6抑制劑在風濕病以外的新適應症。IL-6作為一種多效性細胞因子，參與炎症、免疫和代謝等多種病理生理過程，通過經典通路、反式信號和反式呈遞發揮不同作用，在類風濕關節炎、視神經脊髓炎等疾病中推動炎症進展。目前主流策略為靶向IL-6R，以單克隆抗體阻斷信號傳導。託珠單抗已獲批用於類風濕關節炎、全身型幼年特發性關節炎、鉅細胞動脈炎、多關節型幼年特發性關節炎及細胞因子釋放綜合徵。其在新冠重症中的應用進一步驗證了IL-6在炎症風暴中的核心地位。近年來研究揭示IL-6在心血管疾病中的關鍵作用。非臨床證據顯示IL-6參與斑塊形成、侵蝕與破裂，臨床研究證實其水平升高與重大心血管不良事件風險相關。因此，靶向IL-6成為降低殘餘炎症風險的新方向。諾和諾德於2020年以21億美元收購Corvidia Therapeutics，獲得IL-6單抗Ziltivekimab，目前已啓動4項III期研究，覆蓋心衰、慢性腎病和心梗等適應症。2023年9月9日，諾華宣佈以14億美元收購Tourmaline Bio，獲得其臨床階段IL-6單抗pacibekitug。該藥原由輝瑞開發，後被Tourmaline重新定位至甲狀腺眼病（TED）、動脈粥樣硬化性心血管疾病（ASCVD）及腹主動脈瘤。II期數據顯示，最高劑量組在90天內使hs-CRP水平下降86%，安慰劑組僅下降15%。安全性方面，pacibekitug組嚴重不良事件發生率為10%，低於安慰劑組的11%。儘管療效數據略遜於Ziltivekimab，但pacibekitug具備每季度給藥一次的潛在優勢，較Ziltivekimab每月一次更利於提升患者依從性。在尚無IL-6抑制劑獲批心血管適應症的背景下，pacibekitug有望緊隨Ziltivekimab進入III期臨床，其差異化特徵成為諾華收購的核心動因。然而，IL-6抑制劑在心血管領域的應用仍面臨挑戰。hs-CRP降低雖表明抗炎效果，但需大型III期研究如ZEUS證實其對心肌梗死、卒中或心血管死亡等硬終點的改善作用。此外，長期抑制IL-6可能帶來感染風險增加、血脂異常及肝功能影響。加拿大衞生部曾於2019年發布託珠單抗致嚴重肝損傷的安全警告。除心血管外，IL-6抑制劑正加速探索慢性腎病、眼科疾病和哮喘等領域。Ziltivekimab顯示延緩腎功能惡化潛力；TED的眶周炎症與IL-6密切相關，pacibekitug擬推進該適應症開發；羅氏則佈局長效IL-6抑制劑治療糖尿病性黃斑水腫。雙抗策略亦嶄露頭角，Kodiak Sciences開發的VEGF/IL-6雙抗KSI-501已啓動對比阿柏西普的III期試驗。新型遞送系統與生物標誌物驅動的個體化治療成為研發方向。賽諾菲開發TNF/IL-6雙特異性納米抗體，旨在突破類風濕關節炎療效瓶頸。同時，科學界仍在探究IL-6升高的機制及其在不同疾病中療效差異的原因，例如為何對強直性脊柱炎無效。這些問題的解答將決定IL-6靶點未來的拓展深度。當前，心血管領域只是IL-6新適應症征途的第一站，全球藥企的深入佈局預示着下一輪重磅療法的潛在突破。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"corporation","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}