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国家药监局批准伟立瑞用于治疗视神经脊髓炎谱系疾病成人患者
Guang Zhou Ri Bao· 2025-08-01 10:25
复旦大学附属华山医院神经内科主任医师全超教授表示:该疾病难以预测的多次复发会导致不可逆的残 疾,严重影响患者生活质量,临床治疗应注重缓解期预防复发,急性期快速控制症状,最大程度减少残 疾累积。作为长效补体抑制剂,瑞利珠单抗可精准靶向补体,实现持续获益。 阿斯利康全球高级副总裁、全球研发中国负责人何静博士表示:该疾病是瑞利珠单抗在半年内中国获批 的第二项适应症,这是对药物创新价值的肯定,未来将继续加速科学研发,为更多罕见病患者带来变革 性治疗选择。 (文章来源:广州日报) 国家药监局日前批准伟立瑞®用于治疗抗水通道蛋白4(AQP4)抗体阳性的成人视神经脊髓炎谱系疾病 患者。据悉,该批准基于CHAMPION-NMOSD III期临床试验的积极结果,该研究结果已发表于《神经 科学年鉴》。该研究采用舒立瑞 PREVENT关键性临床试验中的安慰剂组作为外部对照。 瑞利珠单抗达到由独立裁定委员会判定的至研究期间首次复发时间的主要终点。在CHAMPION- NMOSD III期临床试验的中位治疗持续时间73周内,瑞利珠单抗治疗组患者未观察到复发。 此外,与CHAMPION-NMOSD研究主要治疗期的结果一致,在更长期170 ...
依沃西单抗一线治疗NSCLC获批上市,全球首个对比帕博利珠单抗临床3期获显著阳性结果
Ping An Securities· 2025-04-28 05:34
Investment Rating - The industry investment rating is "stronger than the market" [3][47]. Core Viewpoints - The approval of Ivosidenib for first-line treatment of NSCLC in China is a significant milestone, being the first to show positive results in a clinical trial comparing it to Pembrolizumab [3]. - The HARMONi-2 trial demonstrated that Ivosidenib significantly improved progression-free survival (mPFS of 11.14 months vs. 5.82 months for Pembrolizumab), with a hazard ratio (HR) of 0.51, indicating a 49% reduction in the risk of disease progression or death [3]. - The interim analysis of overall survival (OS) at 39% maturity showed a 22.3% reduction in mortality risk for Ivosidenib compared to Pembrolizumab (HR=0.777) [3]. Summary by Sections Industry News - Ivosidenib has received approval for a new indication in first-line treatment of PD-L1 positive locally advanced or metastatic NSCLC based on the HARMONi-2 trial results [3]. - The trial involved a randomized comparison of Ivosidenib and Pembrolizumab, with primary endpoints focused on progression-free survival (PFS) [3]. - Additional studies have shown Ivosidenib's efficacy in various NSCLC settings, including in combination with chemotherapy [4]. Investment Strategy - The report suggests focusing on "innovation," "overseas expansion," "equipment upgrades," and "consumption recovery" as key investment themes [6]. - Companies to watch include innovative drug developers and those with strong overseas market potential, such as BeiGene, Dongcheng Pharmaceutical, and others [6]. Key Companies to Watch - **Nocera Healthcare**: Expected to achieve over 1 billion yuan in revenue from its core product, with a 49% year-on-year growth in sales [7]. - **Sihuan Pharmaceutical**: Strong fundamentals with a stable growth outlook, particularly in the ADC market [10]. - **China Biopharmaceutical**: Rapid revenue growth with a focus on innovative products, particularly in oncology [11]. - **Aier Eye Hospital**: Benefiting from increasing demand for eye care services and a strong pipeline of new products [20].