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表12HBM9161临床二期和三期设计差异
表12HBM9161临床二期和三期设计差异
行业数据
下载Excel
下载图片
原图定位
图片属性
图片格式:PNG
图片大小:289KB
图片尺寸:2351*1158
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所属报告:
和铂医药-首次覆盖:商业化阶段将至研发能力获全球药企背书-220725(49页).pdf
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相关数据
巴托利单抗(HBM9161)作用机制
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行业数据
2025-03-03
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巴托利单抗(HBM9161)III期临床结果
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行业数据
2025-03-03
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表13HBM9161经调整销售峰值6.97亿人民币
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2022-07-27
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HBM9161 三期临床成功率较高,因为我们认为二期数据积极,以及三期临床临床设计与中国二期临床较为相似。和铂医药在 HBM9161 二期数据发布之后的一个多月内提前推进该药进入临床的三期试验。三期试验计划最多 144 人入组受试者,分布在 30 多个临床机构。三期临床主要临床终点与中国二期临床相对有小改动,1)观测时间由 43 天延长为 64 天,据公司于二期数据电话会表示维持治疗阶段看到持续效果良好所以延长观察时间。2)MG-ADL≥3 分,也是基于 Ph2 维持阶段观察到不错的长效改善数据提高了临床终点(此前没有披露)。3)考虑到二期数据较为积极,临床入组标准增加 AChR-Ab/MUSK-Ab 阴性患者,二期只入组了阳性患者。阳性患者占据所有MG 适应症的 80-85%患者人群,假如成功将会有更广泛的标签。整体临床设计变化不重大,我们认为大概率能够取得三期阳性结果,之后最快 2022年提交 BLA上市申请。
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和铂医药-首次覆盖:商业化阶段将至研发能力获全球药企背书-220725(49页).pdf
表9长期使用糖皮质激素副作用
表8不同MG治疗方案优缺点对比
表7重症肌无力患者MGFA分类
表6巴托利单抗国内市场空间可达184亿
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