智通财经APP获悉，强生(JNJ.US)宣布终止其实验性抗体药物尼泊卡利单抗与抗肿瘤坏死因子α(抗TNFα)疗法的联合开发项目，该组合疗法原计划用于治疗类风湿性关节炎(RA)。这一决定基于其2a期DAISY概念验证研究的结果，该研究评估了尼泊卡利单抗与艾伯维(ABBV.US)重磅药物修美乐(Humira)等抗TNFα疗法的联合使用效果。
根据强生披露的12周试验数据，尽管未出现新的安全问题，但尼泊卡利单抗与抗TNFα疗法的组合在类风湿性关节炎患者中并未展现出显著优于单独使用抗TNFα疗法的临床益处。
公司明确表示："基于这些发现，强生决定不再推进该联合疗法在RA治疗领域的临床开发。"
作为强生风湿病领域的重要研发项目，尼泊卡利单抗此前被寄予厚望，公司曾预测其非风险调整后的峰值年营业销售额将超过50亿美元。此次挫折凸显了创新药物开发的高风险性，尤其是在竞争激烈的自身免疫疾病治疗领域。
值得关注的是，修美乐作为全球药王，2021年销售额接近210亿美元，但自2023年起因安进等美国药企推出仿制药而面临销售压力。
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