<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/11/PT-26-11-2025-shutterstock_2468583845-430x241.jpg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/11/PT-26-11-2025-shutterstock_2468583845-430x241.jpg"/></p>
<p>Voyxact 抑制 APRIL，这是 IgA 肾病中的一个关键因素，降低了与其发展相关的血清致病性 Gd-IgA1 水平。来源：sasirin pamai/Shutterstock.com。</p>
<p>大冢制药已获得美国食品和药物管理局（FDA）对 Voyxact（sibeprenlimab-szsi）的加速批准，以减少处于疾病进展风险的成人原发性免疫球蛋白 A 肾病（IgAN）患者的蛋白尿。</p>
<p>Voyxact 以自我注射的皮下剂量每四周给药一次。其批准基于 III 期 VISIONARY 试验的中期结果，该试验在 320 名参与者中显示，蛋白尿在九个月内的安慰剂调整减少率为 51%。</p>
<h3>深入了解 GlobalData</h3>
<ul>
<li><img src="/wp-content/themes/goodlife-wp-B2B/assets/img/report.png" alt="ReportsLogo" original-src="/wp-content/themes/goodlife-wp-B2B/assets/img/report.png"/></li>
</ul>
<p>报告</p>
<h4>LOA 和 PTSR 模型 - Crizanlizumab 在慢性肾病中的应用</h4>
<ul>
<li><img src="/wp-content/themes/goodlife-wp-B2B/assets/img/report.png" alt="ReportsLogo" original-src="/wp-content/themes/goodlife-wp-B2B/assets/img/report.png"/></li>
</ul>
<p>报告</p>
<h4>LOA 和 PTSR 模型 - Crizanlizumab 在骨髓纤维化中的应用</h4>
<h5>深入了解 GlobalData</h5>
<p>商业智能的黄金标准。</p>
<p>了解更多</p>
<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/themes/goodlife-wp-B2B/assets/images/GMS-logo.svg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/themes/goodlife-wp-B2B/assets/images/GMS-logo.svg"/></p>
<h4>发现有效的 B2B 营销</h4>
<p>结合商业智能和编辑卓越，覆盖 36 个领先媒体平台的专业人士。</p>
<p>了解更多</p>
<p>这是第一种旨在阻断 A 增殖诱导配体（APRIL）的治疗。</p>
<p>蛋白尿的减少作为一个替代标志，与延缓肾衰竭的进展相关。FDA 的批准是基于这一标志的加速通道授予的。</p>
<p>Voyxact 对 IgAN 患者肾功能下降的长期影响尚待确定。</p>
<p>持续批准取决于正在进行的 VISIONARY III 期研究的确认，该研究评估 24 个月内通过估计的肾小管滤过率（eGFR）减少的疾病进展，数据预计在 2026 年初发布。</p>
<p><img src="/wp-content/themes/goodlife-wp-B2B/assets/images/strategic-int.png" alt="" original-src="/wp-content/themes/goodlife-wp-B2B/assets/images/strategic-int.png"/></p>
<p>GlobalData 战略情报</p>
<h1>美国关税正在变化 - 你会反应还是预见？</h1>
<p>不要让政策变化让你措手不及。通过实时数据和专家分析保持主动。</p>
<p>来自 GlobalData</p>
<p>了解更多关于战略情报</p>
<p>大冢制药执行副总裁兼首席医疗官 John Kraus 表示：“Voyxact 的可用性代表了一种新颖的靶向方法，旨在帮助管理 IgAN 患者的这一复杂疾病。</p>
<p>“凭借其靶向机制、强大的疗效、安全性和每四周一次的给药方案，Voyxact 为 IgAN 患者提供了一种新选择。我们认识到 IgAN 急需新的治疗选择，感谢继续参与我们临床试验计划的患者和医疗专业人士。”</p>
<p>Voyxact 抑制 APRIL，这是 IgAN 发病机制中四重打击过程的一个关键因素，促进致病性缺乏半乳糖的 IgA1（Gd-IgA1）的产生。阻断 APRIL 降低了与 IgAN 发展相关的血清 Gd-IgA1 水平。</p>
<p>VISIONARY 是一项安慰剂对照的全球随机双盲研究，涉及 510 名接受标准支持治疗的 IgAN 成人。</p>
<p>2025 年 5 月，美国 FDA 接受了大冢制药的 sibeprenlimab 生物制剂许可申请 进行审查。</p>
<h2>制药技术卓越奖 - 参赛的好处</h2>
<p>获得你应得的认可！制药技术卓越奖 庆祝创新、领导力和影响力。通过参赛，你展示了你的成就，提高了你的行业形象，并将自己定位在推动制药进步的顶尖领导者之中。不要错过脱颖而出的机会 - 今天就提交你的参赛作品！</p>
<p>立即提名</p>

大冢制药(ADR)

<p>大冢制药 (ADR) 已获得美国 FDA 的加速批准，用于治疗原发性 IgA 肾病（IgAN）成人患者的 Voyxact（sibeprenlimab-szsi），该疗法旨在减少蛋白尿。Voyxact 每四周皮下给药一次，在三期临床试验中显示出 51% 的安慰剂调整后蛋白尿减少。该批准基于蛋白尿减少作为替代标志物，肾功能的长期影响仍在研究中。持续批准取决于预计在 2026 年获得的进一步试验结果</p>

<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/11/PT-26-11-2025-shutterstock_2468583845-430x241.jpg" alt="" original-src="https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/11/PT-26-11-2025-shutterstock_2468583845-430x241.jpg"/></p>
<p>Voyxact inhibits APRIL, a key factor in IgA nephropathy, reducing serum pathogenic Gd-IgA1 levels implicated in its development. Credit: sasirin pamai/Shutterstock.com.</p>
<div class="lb-trans"><p>Voyxact 抑制 APRIL，这是 IgA 肾病中的一个关键因素，降低了与其发展相关的血清致病性 Gd-IgA1 水平。来源：sasirin pamai/Shutterstock.com。</p>
</div><p>Otsuka Pharmaceutical has secured accelerated approval from the US Food and Drug Administration (FDA) for Voyxact (sibeprenlimab-szsi) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at disease progression risk.</p>
<div class="lb-trans"><p>大冢制药已获得美国食品和药物管理局（FDA）对 Voyxact（sibeprenlimab-szsi）的加速批准，以减少处于疾病进展风险的成人原发性免疫球蛋白 A 肾病（IgAN）患者的蛋白尿。</p>
</div><p>Voyxact is administered as a self-injected subcutaneous dose every four weeks. Its approval was based on the interim results of the Phase III VISIONARY trial, which demonstrated a 51% placebo-adjusted reduction in proteinuria at nine months in 320 participants.</p>
<div class="lb-trans"><p>Voyxact 以自我注射的皮下剂量每四周给药一次。其批准基于 III 期 VISIONARY 试验的中期结果，该试验在 320 名参与者中显示，蛋白尿在九个月内的安慰剂调整减少率为 51%。</p>
</div><h3>Go deeper with GlobalData</h3>
<div class="lb-trans"><h3>深入了解 GlobalData</h3>
</div><ul>
<li><img src="/wp-content/themes/goodlife-wp-B2B/assets/img/report.png" alt="ReportsLogo" original-src="/wp-content/themes/goodlife-wp-B2B/assets/img/report.png"/></li>
</ul>
<div class="lb-trans"><ul>
<li><img src="/wp-content/themes/goodlife-wp-B2B/assets/img/report.png" alt="ReportsLogo" original-src="/wp-content/themes/goodlife-wp-B2B/assets/img/report.png"/></li>
</ul>
</div><p>Reports</p>
<div class="lb-trans"><p>报告</p>
</div><h4>LOA and PTSR Model - Crizanlizumab in Chronic Kidney Disease (Chron...</h4>
<div class="lb-trans"><h4>LOA 和 PTSR 模型 - Crizanlizumab 在慢性肾病中的应用</h4>
</div><ul>
<li><img src="/wp-content/themes/goodlife-wp-B2B/assets/img/report.png" alt="ReportsLogo" original-src="/wp-content/themes/goodlife-wp-B2B/assets/img/report.png"/></li>
</ul>
<div class="lb-trans"><ul>
<li><img src="/wp-content/themes/goodlife-wp-B2B/assets/img/report.png" alt="ReportsLogo" original-src="/wp-content/themes/goodlife-wp-B2B/assets/img/report.png"/></li>
</ul>
</div><p>Reports</p>
<div class="lb-trans"><p>报告</p>
</div><h4>LOA and PTSR Model - Crizanlizumab in Myelofibrosis</h4>
<div class="lb-trans"><h4>LOA 和 PTSR 模型 - Crizanlizumab 在骨髓纤维化中的应用</h4>
</div><h5>Go deeper with GlobalData</h5>
<div class="lb-trans"><h5>深入了解 GlobalData</h5>
</div><p>The gold standard of business intelligence.</p>
<div class="lb-trans"><p>商业智能的黄金标准。</p>
</div><p>Find out more</p>
<div class="lb-trans"><p>了解更多</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/themes/goodlife-wp-B2B/assets/images/GMS-logo.svg" alt="" original-src="https://www.pharmaceutical-technology.com/wp-content/themes/goodlife-wp-B2B/assets/images/GMS-logo.svg"/></p>
<h4>Discover B2B Marketing That Performs</h4>
<div class="lb-trans"><h4>发现有效的 B2B 营销</h4>
</div><p>Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.</p>
<div class="lb-trans"><p>结合商业智能和编辑卓越，覆盖 36 个领先媒体平台的专业人士。</p>
</div><p>Find out more</p>
<div class="lb-trans"><p>了解更多</p>
</div><p>It is the first therapy designed to block A-proliferation-inducing ligand (APRIL).</p>
<div class="lb-trans"><p>这是第一种旨在阻断 A 增殖诱导配体（APRIL）的治疗。</p>
</div><p>Proteinuria reduction serves as a surrogate marker linked to delayed progression to kidney failure. The FDA approval was granted under the accelerated pathway based on this marker.</p>
<div class="lb-trans"><p>蛋白尿的减少作为一个替代标志，与延缓肾衰竭的进展相关。FDA 的批准是基于这一标志的加速通道授予的。</p>
</div><p>The long-term effect of Voyxact on kidney function decline in IgAN is yet to be established.</p>
<div class="lb-trans"><p>Voyxact 对 IgAN 患者肾功能下降的长期影响尚待确定。</p>
</div><p>Continued approval depends on confirmation from the ongoing VISIONARY Phase III study, which evaluates disease progression through estimated glomerular filtration rate (eGFR) reduction at 24 months, with data anticipated in early 2026.</p>
<div class="lb-trans"><p>持续批准取决于正在进行的 VISIONARY III 期研究的确认，该研究评估 24 个月内通过估计的肾小管滤过率（eGFR）减少的疾病进展，数据预计在 2026 年初发布。</p>
</div><p><img src="/wp-content/themes/goodlife-wp-B2B/assets/images/strategic-int.png" alt="" original-src="/wp-content/themes/goodlife-wp-B2B/assets/images/strategic-int.png"/></p>
<p>GlobalData Strategic Intelligence</p>
<div class="lb-trans"><p>GlobalData 战略情报</p>
</div><h1>US Tariffs are shifting - will you react or anticipate?</h1>
<div class="lb-trans"><h1>美国关税正在变化 - 你会反应还是预见？</h1>
</div><p>Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.</p>
<div class="lb-trans"><p>不要让政策变化让你措手不及。通过实时数据和专家分析保持主动。</p>
</div><p>By GlobalData</p>
<div class="lb-trans"><p>来自 GlobalData</p>
</div><p>Learn more about Strategic Intelligence</p>
<div class="lb-trans"><p>了解更多关于战略情报</p>
</div><p>Otsuka executive vice-president and chief medical officer John Kraus stated: “The availability of Voyxact represents a novel targeted approach to help manage this complex disease for patients living with IgAN.</p>
<div class="lb-trans"><p>大冢制药执行副总裁兼首席医疗官 John Kraus 表示：“Voyxact 的可用性代表了一种新颖的靶向方法，旨在帮助管理 IgAN 患者的这一复杂疾病。</p>
</div><p>“With its targeted mechanism, strong efficacy, safety profile and once-every-four-weeks dosing, Voyxact offers a new option for IgAN patients. We recognise the urgent need for new treatment options for IgAN and are thankful for the patients and healthcare professionals who continue to participate in our clinical trial programme.”</p>
<div class="lb-trans"><p>“凭借其靶向机制、强大的疗效、安全性和每四周一次的给药方案，Voyxact 为 IgAN 患者提供了一种新选择。我们认识到 IgAN 急需新的治疗选择，感谢继续参与我们临床试验计划的患者和医疗专业人士。”</p>
</div><p>Voyxact inhibits APRIL, a key factor in the four-hit process of IgAN pathogenesis, promoting production of pathogenic galactose-deficient IgA1 (Gd-IgA1). Blocking APRIL reduces serum Gd-IgA1 levels implicated in IgAN development.</p>
<div class="lb-trans"><p>Voyxact 抑制 APRIL，这是 IgAN 发病机制中四重打击过程的一个关键因素，促进致病性缺乏半乳糖的 IgA1（Gd-IgA1）的产生。阻断 APRIL 降低了与 IgAN 发展相关的血清 Gd-IgA1 水平。</p>
</div><p>VISIONARY is a placebo-controlled, global, randomised, double-blind study of 510 adults with IgAN on standard supportive therapy.</p>
<div class="lb-trans"><p>VISIONARY 是一项安慰剂对照的全球随机双盲研究，涉及 510 名接受标准支持治疗的 IgAN 成人。</p>
</div><p>In May 2025, the US FDA accepted Otsuka Pharmaceutical’s biologics licence application for sibeprenlimab for review.</p>
<div class="lb-trans"><p>2025 年 5 月，美国 FDA 接受了大冢制药的 sibeprenlimab 生物制剂许可申请 进行审查。</p>
</div><h2>Pharmaceutical Technology Excellence Awards - The Benefits of Entering</h2>
<div class="lb-trans"><h2>制药技术卓越奖 - 参赛的好处</h2>
</div><p>Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today!</p>
<div class="lb-trans"><p>获得你应得的认可！制药技术卓越奖 庆祝创新、领导力和影响力。通过参赛，你展示了你的成就，提高了你的行业形象，并将自己定位在推动制药进步的顶尖领导者之中。不要错过脱颖而出的机会 - 今天就提交你的参赛作品！</p>
</div><p>Nominate Now</p>
<div class="lb-trans"><p>立即提名</p>
</div>

FDA 授予大冢制药 (ADR) 的 IgAN 疗法加速批准