生物制品行业深度报告：多发性硬化百亿美金市场 BTKI发展前景广阔

开源证券2025-07-30

MS 全球存量患者基数较大，减少复发与延缓神经退行是治疗的核心目标多发性硬化（Multiple Sclerosis, MS）是一种由免疫系统介导的中枢神经系统炎性脱髓鞘疾病，“空间多发性”和“时间多发性”是其核心特点。MS 地理分布呈现鲜明的“纬度梯度”现象，高纬度地区发病率较高；根据Frost & Sullivan数据，全球与中国多发性硬化存量患者数量预计将在2030 年达到371/6 万人。...

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单抗疗效整体优于口服产品，2024 年销售占比已超60%。已上市产品在控制炎症、减少复发上具有较好疗效，获批适应症主要聚焦在RMS 领域（RRMS+aSPMS）；针对PMS 领域（PPMS+nrSPMS），仅奥瑞利珠单抗针对PPMS 获批上市，存在较大未满足临床需求。BTK 抑制剂有望填补PMS 领域治疗空白，2025H2 数据催化密集BTK 抑制剂具有较好的血脑屏障穿透性，可通过调控B 细胞和小胶质细胞等关键免疫细胞，分别抑制炎症反应和神经退行性进程，为PMS 提供了潜在有效的治疗手段。针对MS，多家MNC 已加速布局BTK 抑制剂，Sanofi 的Tolebrutinib针对nrSPMS 已申报NDA，罗氏的Fenebrutinib、诺华的Remibrutinib 已进入III期临床；诺诚健华的奥布替尼针对PPMS 已开启全球III 期临床，全球进度领先，早研针对RMS 适应症影像学表现优于竞品，有较强出海潜力。（1）PPMS：仅奥瑞利珠单抗一款产品获批上市，Tolebrutinib 与Fenebrutinib 预计在2025H2 读出III 期主要临床终点数据；BTK 抑制剂在PPMS 领域尚未实现概念验证，数据读出后有望快速提升BTK 抑制剂在PMS 领域的价值。（2）nrSPMS：尚无产品获批上市，凭借在HERCULES 试验中优异的临床数据，Tolebrutinib 针对nrSPMS 的上市申请获FDA 受理并获得优先审评，PDUFA 时间为2025 年9 月28 日，有望成为首个在nrSPMS 领域获批上市的药物。投资建议MS 全球存量患者基数较大，存量产品市场规模约200 亿美元。现有上市产品获批适应症聚焦RMS 领域，对神经保护效果较弱；BTK 抑制剂可透过血脑屏障，抑制中枢小胶质细胞活化并减少促炎因子释放，实现阻断慢性神经炎症、延缓神经退行性进程的功能，有望填补PMS 领域治疗空白。随着2025H2 Sanofi 的Tolebrutinib 与Roche 的Fenebrutinib 针对PPMS 的III 期数据预期读出，以及Tolebrutinib 针对nrSPMS 预期获批，赛道景气度持续提升，相关标的有望受益。受益标的：诺诚健华、翰森制药、云顶新耀、恒瑞医药、百济神州-U 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生物制品行业深度报告：多发性硬化 百亿美金市场 BTKI发展前景广阔

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生物制品行业深度报告：多发性硬化百亿美金市场 BTKI发展前景广阔