金吾财讯 | 交银国际研报指,荣昌生物(09995)在ESMO大会上展示了III期RC48-C016 研究,结果显示PFS和OS双主要研究终点均已达到,并展现出统计学和临床显著的生存获益:DV+T组vs. 化疗组的中位PFS为13.1 vs. 6.5 个月,HR=0.36;中位 OS 为 31.5 vs 16.9 个月,HR=0.54。亚组分析结果显示,DV+T疗法在HER2低表达和中高表达患者中均取得统计学优效。与已获批用于一线UC的维恩妥尤单抗+K药方案相比,DV+T疗法的生存获益与安全性结果相似。海外合作伙伴辉瑞正在开展一项维迪西妥联合K药针对同适应症的国际多中心III期研究。该机构指,2025 ACR公布泰它西普的中国内地SS III 期结果:主要终点和所有次要终点均已达到,160mg治疗组/80mg 治疗组/安慰剂对照组中,24周时的ESSDAI较基线变化(主要终点)分别为-4.4/-3.0/-0.6,48 周时持续改善至-4.6/-3.2/-0.4。该机构维持全球销售峰值超25亿美元的预测。基于优异的临床数据,该机构对维迪西妥和泰它西普销售前景边际更乐观,上调2025-27年公司收入预测上调1-4%,中国内地经PoS调整峰值销售预测分别上调至29亿/49亿元人民币,上调目标价至109港元。泰它西普巨大的海外自免市场价值有望逐步兑现,维持买入评级。
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