国产创新药多点突破，抢滩1000亿美元规模炎症性肠病药物市场

制药网2025-12-11

炎症性肠病(Inflammatory Bowel Disease,IBD)包括溃疡性结肠炎(Ulcerative Colitis,UC)和克罗恩病(Crohn Disease,CD)，是一种复杂的自身免疫性疾病，具有大量未满足临床需求。有数据预测，到2032年全球IBD市场(UC+CD)将达到1000亿美元规模。面对这一机遇，国内药企纷纷加码布局，在S1P调节剂、IL-23 p19单抗、JAK1...

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href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20251211112914a7311dcb&s=b><strong>制药网</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>炎症性肠病(Inflammatory Bowel Disease,IBD)包括溃疡性结肠炎(Ulcerative Colitis,UC)和克罗恩病(Crohn Disease,CD)，是一种复杂的自身免疫性疾病，具有大量未满足临床需求。有数据预测，到2032年全球IBD市场(UC+CD)将达到1000亿美元规模。面对这一机遇，国内药企纷纷加码布局，在S1P调节剂、IL-23 p19单抗、JAK1...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20251211112914a7311dcb&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":"LU2488822045.USD","symbol_name":"ALLIANZ CHINA HEALTHY LIVING \"AT\" (USD) 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mg组达到临床缓解的受试者比例分别是20.0%和14.0%，均显著高于安慰剂组(2.0%；p <0.05)。匹康奇拜单抗200 mg组和600 mg组达到临床应答的受试者分别为54.0%和68.0%，均显著高于安慰剂组(22.0%；p <0.001)。此外，匹康奇拜单抗200 mg组和600mg组达到症状缓解、内镜缓解或黏膜愈合的受试者比例均高于安慰剂组。2021年2月，恒瑞医药曾宣布，其子公司瑞石生物治疗溃疡性结肠炎的随机、双盲、安慰剂对照、多中心的全球II期临床研究RSJ10101(AMBER2)，达到主要及关键次要研究终点。SHR0302是一种高选择性的JAK1抑制剂，可通过抑制JAK1信号传导发挥抗炎和抑制免疫的生物学效应。诺诚健华与益方生物布局的高选择性TYK2抑制剂有望在安全性上实现突破。TYK2抑制剂的作用机制通过阻断IL-23、IL-12等炎症因子信号通路，为治疗炎症性肠病(IBD)等自免疾病提供了可能。诺诚健华和益方生物均明确表示将推进TYK2抑制剂在IBD等领域的临床试验。益方生物D-2570的溃疡性结肠炎适应症已进入监管审批阶段，若成功拓展，有望打开更大的市场空间。此外，辰欣药业与和美药业则分别在NLRP3和PDE4等前沿靶点上积极探索。其中，Hemay005是和美药业开发的小分子选择性PDE4抑制剂。PDE抑制剂是一类作用于靶细胞中特定PDE的药物，可通过升高细胞内cAMP和/或cGMP水平激活蛋白激酶A/G，促进下游效应蛋白磷酸化，在不同炎症相关疾病中疗效显著。目前评估Hemay005用于中度至重度溃疡性结肠炎的有效性的一项临床II期研究正在进行中。从已申报上市的成熟管线，到临床阶段的潜力产品，再到前沿靶点的探索性研究，国内药企在IBD领域的布局已形成多层次、多方位的发展格局。随着这些创新药物的不断推进，IBD换着有望迎来新的治疗选择。","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":"","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 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