中信证券：新老管线数据读出频现 MNC加速IBD领域布局

智通财经2025-12-11

智通财经APP获悉，中信证券发布研报称，IBD作为自身免疫疾病中的“硬骨头”，拥有巨大的未满足临床需求和广阔的市场空间。尽管IBD领域的靶点不断丰富，但诱导期的临床缓解率(经安慰剂调整后)依然非常有限，大多数药物的临床缓解率在10%-20%之间的水平，已获批药物的高剂量组临床缓解率通常在15%以上。当前IBD的治疗新老产品更新迭代，对新机制新疗法的需求急迫，注射长效化+口服多点开花。MNC加速...

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Disease,CD)，是一种复杂的自身免疫性疾病，目前发病机制仍不清晰，无治愈疗法，仍有大量未满足临床需求。根据集萃药康微信公众号，全世界有超过1000万人患有克罗恩病和溃疡性结肠炎，该机构预测到2025年，中国的炎症性肠病患者将达到150万人。根据Organovo官网的预测，到2032年全球IBD市场(UC+CD)将达到1000亿美元规模。IBD的治疗药品：新老产品更新迭代，注射长效化+口服多点开花1998年靶向TNF-α的英夫利昔单抗获批CD适应症，开启了IBD的靶向治疗时代，此后阿达木单抗、维得利珠单抗、乌司奴单抗不断抬高IBD领域的市场潜力。当前IBD领域进入了IL-23 p19单抗+JAK抑制剂的快速放量阶段。尽管IBD领域的靶点不断丰富，但诱导期的临床缓解率(Clinical remission，经安慰剂调整后)依然非常有限，大多数药物的临床缓解率在10%-20%之间的水平，已获批药物的高剂量组临床缓解率通常在15%以上。新一代临床在研疗法中，TL1A靶向单抗临床数据优异，在IBD的平均疗效普遍较高;其中Sanofi和TEVA合作的TL1A单抗(duvakitug)在2024年12月公布的二期实验中，duvakitug高剂量在UC上实现了47.8%的临床缓解率，经安慰剂调整后为27%，展现出单药BIC潜力;在CD上，duvakitug也实现了48%的内窥镜缓解率(经安慰剂调整后为35%)。多种针对炎症调节、T细胞调节、肠道调节等不同机制的产品火热开发。S1P、JAK、TYK2等口服小分子药物凭借便捷性和独特机制正逐步替代传统注射制剂，成为“升阶梯”治疗的重要选择。MNC加速IBD领域布局，中国创新药企业在差异化赛道崭露头角作为自身免疫疾病领域中，患者人数众多且当前一年维持期疗效仍仅有30%-50%临床缓解率的适应症，IBD吸引了众多MNC布局。老玩家通过新产品巩固领先优势;慢病头部企业通过资源倾斜快速布局;肿瘤领域核心玩家通过BD、收购等模式进入。根据过往交易规模以及MNC对产品峰值的预期，该行预计一项临床阶段的优质IBD资产的交易对价在20亿美金以上。中国企业紧跟全球趋势并展现出差异化创新能力：云顶新耀引进的S1P调节剂伊曲莫德已在国内申报上市，填补了口服一线先进疗法的空白;信达生物的IL-23 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