金吾财讯 | 罗氏（RHHBY）获得欧洲药品管理局（EMA）人用药品委员会（CHMP）积极审查意见，建议批准其旗下的抗CD20单克隆抗体药物Ocrevus（静脉输注剂型），用于治疗10岁及以上儿童和青少年的复发型多发性硬化症（RMS）。预计欧盟委员会将于近期做出最终批准决定。这一建议主要基于其关键III期OPERETTA2临床试验数据。研究显示，与标准疗法芬戈莫德（Fingolimod）相比，Ocrevus可将儿科患者的疾病复发风险大幅降低48%，在抑制脑部新发或扩大病灶（减少48%）及活性病灶（减少87%）方面均表现出显著优效性，且整体安全性与成人患者一致。据介绍，继美国FDA于2026年5月批准该适应症后，若欧盟顺利获批，Ocrevus将成为欧洲首个面向10岁及以上儿科患者的高效抗CD20疗法，进一步巩固罗氏在神经科学及多发性硬化症治疗领域的市场领先地位。
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.