智通财经APP获悉,康宁杰瑞制药-B(09966)涨超12%,截至发稿,涨12.85%,报7.29港元,成交额811.12万港元。
消息面上,康宁杰瑞生物制药与石药集团共同宣布,HER2双特异性抗体KN026联合化疗二线及以上治疗HER2阳性胃癌(包括胃-食管结合部腺癌)的Ⅱ/Ⅲ期临床研究(研究编号:KN026-001)已完成首次期中分析,经独立数据监察委员会(IDMC)评估,达到预先设定的无进展生存期(PFS)的主要终点,具有统计学显著性和临床意义。PFS期中分析结果显示,与现有标准治疗相比,KN026联合化疗显著改善了患者的PFS,降低了疾病进展/死亡的风险,并具有OS(总生存期)获益趋势。
东吴证券此前研报曾指出,KN026是基于成熟抗体平台开发的HER2双抗。该产品国内权益已出售给石药集团,首付款与里程碑总计10 亿元,双位数销售分成。其适应症为HER2 阳性BC一线、新辅/辅助治疗和 GC/GEJC 二线及以上治疗。预计25年读出数据 Pre-BLA,26年底27年初国内上市。目前其临床结果十分优秀,与多西他赛联用治疗HER2 阳性BC 的PFS 为 27.7 个月。根据测算,预计KN026两适应症上市后2032年达到销售峰值约33.71 亿元。
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