国信证券：FXI抑制剂有望成为下一代抗凝药物建议关注恒瑞医药(600276.SH)

智通财经2025-12-15

智通财经APP获悉，国信证券发布研报称，全球抗凝药市场规模超200亿美元，现有的抗凝药物在预防血栓的同时，会带来额外的出血风险;抗凝血药物的有效性(抗血栓能力)和安全性(减少出血风险)仍有提升空间。FXI/FXIa有望成为现有抗凝血药物的升级和补充，具备百亿美金以上的潜在市场空间。建议关注恒瑞医药(600276.SH，01276)：FXI单抗SHR-2004进入3期临床，在国产分子中领先;并关注...

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It is recommended to pay attention to Hengrui Medicine (600276. SH)","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"600276":1.5,"002736":1.5,"01276":1.5},"content_text":"智通财经APP获悉，国信证券发布研报称，全球抗凝药市场规模超200亿美元，现有的抗凝药物在预防血栓的同时，会带来额外的出血风险;抗凝血药物的有效性(抗血栓能力)和安全性(减少出血风险)仍有提升空间。FXI/FXIa有望成为现有抗凝血药物的升级和补充，具备百亿美金以上的潜在市场空间。建议关注恒瑞医药(600276.SH，01276)：FXI单抗SHR-2004进入3期临床，在国产分子中领先;并关注拥有FXI小核酸药物管线的公司。国信证券主要观点如下：FXI/FXIa抑制剂有望成为安全性更优的抗凝药物现有抗凝血药物均作用于凝血的共同通路，FXI仅参与内源性凝血通路以及血栓的正反馈放大，抑制FXI活性有望在抗凝血的同时减少出血的风险。目前尚无FXI/FXIa抑制剂获批上市，靶向抗体、小分子、小核酸等多种药物形态处于临床阶段，其中诺华的abelacimab、拜耳的asundexian、BMS/强生的milvexian等5个候选分子正在进行注册性临床。FXI/FXIa抑制剂在多个适应症中均验证了更优的安全性。FXI/FXIa抑制剂在多个适应症中挑战标准治疗近期，拜耳的asundexian在卒中二级预防的3期临床中取得优效，成为首个达到关键临床主要临床终点的FXI/FXIa抑制剂。此前，asundexian在房颤患者的卒中预防的3期临床中未达到有效性终点，milvexian在ACS患者中相比安慰剂同样未达到优效。根据现有临床数据，FXI/FXIa抑制剂相比于DOACs体现出显著的安全性优势，可能在高出血风险的患者中占据竞争优势。另一方面，在内源性凝血通路的作用占主导地位的适应症中，FXI/FXIa抑制剂同样有望进行覆盖。FXI小核酸药物可能具备差异化的竞争优势FXI小核酸药物仍处在较早期的研发阶段，瑞博生物的SR059、靖因药业的SRSD107正进行2期临床研究。早期的PK/PD数据显示，FXI siRNA药物对于FXI活性有高效的抑制，并且可能做到Q3M的注射周期，能为慢病用药带来依从性的优势。风险提示：临床结果不及预期的风险、临床进度不及预期的风险、海外开发不及预期的风险、商业化不及预期的风险。","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":"productRelease","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.36.2","shortVersion":"4.36.2","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2591699288","isCrawlerRequest":true}

国信证券：FXI抑制剂有望成为下一代抗凝药物 建议关注恒瑞医药(600276.SH)

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国信证券：FXI抑制剂有望成为下一代抗凝药物建议关注恒瑞医药(600276.SH)