IL-6靶点迎新战局：诺华重金入局心血管领域

DoNews

09/24

IL-6作为自免疾病的重要靶点已取得显著成功，全球已有4款靶向IL-6/IL-6R的药物获批上市。首款IL-6R单抗托珠单抗凭借先发优势和多项适应症长期占据市场主导地位，并在2021年因获FDA紧急授权用于重症新冠治疗，销售额达到39.6亿美元峰值。随着托珠单抗专利到期，生物类似药陆续进入市场，竞争加剧。药企纷纷转向差异化布局，拓展IL-6抑制剂在风湿病以外的新适应症。IL-6作为一种多效性...

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11:09","share_image_url":"https://static.laohu8.com/9a95c1376e76363c1401fee7d3717173","id":"2569272913","market":"us","top_or_hot":-1,"title":"IL-6靶点迎新战局：诺华重金入局心血管领域","media":"DoNews","content":"<div>\n<p>IL-6作为自免疾病的重要靶点已取得显著成功，全球已有4款靶向IL-6/IL-6R的药物获批上市。首款IL-6R单抗托珠单抗凭借先发优势和多项适应症长期占据市场主导地位，并在2021年因获FDA紧急授权用于重症新冠治疗，销售额达到39.6亿美元峰值。随着托珠单抗专利到期，生物类似药陆续进入市场，竞争加剧。药企纷纷转向差异化布局，拓展IL-6抑制剂在风湿病以外的新适应症。IL-6作为一种多效性...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250924111222a69a4653&s=b\">网页链接</a>\n\n</div>\n","source":"tencent","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>IL-6靶点迎新战局：诺华重金入局心血管领域</title>\n<style 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href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250924111222a69a4653&s=b\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4588","symbol_name":"碎股","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 span{font-size:12px;#descriptionStyle#;}.footer-note{#statement#}","selectors":".mod-LoadTzbdNews, body","filters":".relate-stock, .hot-list, .recom-box, .wx-sou","directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2569272913","pubTimestamp":1758683342,"columns":[],"sourceInfo":{"source_id":"tencent","name":"腾讯"},"weMediaInfo":null,"summary":"目前主流策略为靶向IL-6R，以单克隆抗体阻断信号传导。其在新冠重症中的应用进一步验证了IL-6在炎症风暴中的核心地位。近年来研究揭示IL-6在心血管疾病中的关键作用。非临床证据显示IL-6参与斑块形成、侵蚀与破裂，临床研究证实其水平升高与重大心血管不良事件风险相关。因此，靶向IL-6成为降低残余炎症风险的新方向。然而，IL-6抑制剂在心血管领域的应用仍面临挑战。此外，长期抑制IL-6可能带来感染风险增加、血脂异常及肝功能影响。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"BK4588":"碎股","IE00BZ1G4Q59.USD":"LEGG MASON CLEARBRIDGE US EQUITY SUSTAINABILITY LEADER \"A\"(USD) INC (A)","IE00BKVL7J92.USD":"Legg Mason ClearBridge - US Equity Sustainability Leaders A Acc USD","IE0009355771.USD":"骏利亨德森环球生命科技A Acc","LU0320765489.SGD":"FTIF - Franklin Mutual US Value A Acc SGD","LU1093756325.SGD":"FTIF - Franklin K2 Alt Strat Fd A (acc) SGD-H1","BK4007":"制药","LU0211331839.USD":"FRANKLIN MUTUAL GLB DISCOVERY \"A\" (USD) 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field","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"NVO":0.9,"NVS":1.5,"PFE":0.9},"content_text":"IL-6作为自免疾病的重要靶点已取得显著成功，全球已有4款靶向IL-6/IL-6R的药物获批上市。首款IL-6R单抗托珠单抗凭借先发优势和多项适应症长期占据市场主导地位，并在2021年因获FDA紧急授权用于重症新冠治疗，销售额达到39.6亿美元峰值。随着托珠单抗专利到期，生物类似药陆续进入市场，竞争加剧。药企纷纷转向差异化布局，拓展IL-6抑制剂在风湿病以外的新适应症。IL-6作为一种多效性细胞因子，参与炎症、免疫和代谢等多种病理生理过程，通过经典通路、反式信号和反式呈递发挥不同作用，在类风湿关节炎、视神经脊髓炎等疾病中推动炎症进展。目前主流策略为靶向IL-6R，以单克隆抗体阻断信号传导。托珠单抗已获批用于类风湿关节炎、全身型幼年特发性关节炎、巨细胞动脉炎、多关节型幼年特发性关节炎及细胞因子释放综合征。其在新冠重症中的应用进一步验证了IL-6在炎症风暴中的核心地位。近年来研究揭示IL-6在心血管疾病中的关键作用。非临床证据显示IL-6参与斑块形成、侵蚀与破裂，临床研究证实其水平升高与重大心血管不良事件风险相关。因此，靶向IL-6成为降低残余炎症风险的新方向。诺和诺德于2020年以21亿美元收购Corvidia Therapeutics，获得IL-6单抗Ziltivekimab，目前已启动4项III期研究，覆盖心衰、慢性肾病和心梗等适应症。2023年9月9日，诺华宣布以14亿美元收购Tourmaline Bio，获得其临床阶段IL-6单抗pacibekitug。该药原由辉瑞开发，后被Tourmaline重新定位至甲状腺眼病（TED）、动脉粥样硬化性心血管疾病（ASCVD）及腹主动脉瘤。II期数据显示，最高剂量组在90天内使hs-CRP水平下降86%，安慰剂组仅下降15%。安全性方面，pacibekitug组严重不良事件发生率为10%，低于安慰剂组的11%。尽管疗效数据略逊于Ziltivekimab，但pacibekitug具备每季度给药一次的潜在优势，较Ziltivekimab每月一次更利于提升患者依从性。在尚无IL-6抑制剂获批心血管适应症的背景下，pacibekitug有望紧随Ziltivekimab进入III期临床，其差异化特征成为诺华收购的核心动因。然而，IL-6抑制剂在心血管领域的应用仍面临挑战。hs-CRP降低虽表明抗炎效果，但需大型III期研究如ZEUS证实其对心肌梗死、卒中或心血管死亡等硬终点的改善作用。此外，长期抑制IL-6可能带来感染风险增加、血脂异常及肝功能影响。加拿大卫生部曾于2019年发布托珠单抗致严重肝损伤的安全警告。除心血管外，IL-6抑制剂正加速探索慢性肾病、眼科疾病和哮喘等领域。Ziltivekimab显示延缓肾功能恶化潜力；TED的眶周炎症与IL-6密切相关，pacibekitug拟推进该适应症开发；罗氏则布局长效IL-6抑制剂治疗糖尿病性黄斑水肿。双抗策略亦崭露头角，Kodiak Sciences开发的VEGF/IL-6双抗KSI-501已启动对比阿柏西普的III期试验。新型递送系统与生物标志物驱动的个体化治疗成为研发方向。赛诺菲开发TNF/IL-6双特异性纳米抗体，旨在突破类风湿关节炎疗效瓶颈。同时，科学界仍在探究IL-6升高的机制及其在不同疾病中疗效差异的原因，例如为何对强直性脊柱炎无效。这些问题的解答将决定IL-6靶点未来的拓展深度。当前，心血管领域只是IL-6新适应症征途的第一站，全球药企的深入布局预示着下一轮重磅疗法的潜在突破。","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"}}}