<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/shutterstock_2193782839-1-430x241.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/24/2025/12/shutterstock_2193782839-1-430x241.jpg"/></p>
<p>武田计划在 2026 年向 FDA 及其他监管机构提交新药申请（NDA）。图片来源：Tada Images / Shutterstock.com。</p>
<p>武田的每日一次口服斑块型银屑病（PsO）药物在两项关键试验中达到了所有终点，预计将在 2026 年向美国食品药品监督管理局（FDA）申请批准。</p>
<p>在随机、多中心、双盲的 III 期试验（NCT06088043 和 NCT06108544）中，zasocitinib（一种口服酪氨酸激酶 2（TYK2）抑制剂）在中度至重度 PsO 成人患者中达到了所有主要和次要终点。</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 - GSK-2831781 在斑块型银屑病中的应用</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>
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<p>报告</p>
<h4>LOA 和 PTSR 模型 - IMP-731 在斑块型银屑病中的应用</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>发现高效的 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>这些研究均为安慰剂对照和活性对照，显示出 zasocitinib 在治疗 16 周后在静态医生全球评估（sPGA）0/1 和银屑病面积和严重指数（PASI）75 方面优于安慰剂，PASI 75 的反应率在第四周就已显现，并在第 24 周继续增加。</p>
<p>研究还达到了所有 44 个排名的次要终点，包括 PASI 90、PASI 100 和 sPGA 0，相较于安慰剂和 apremilast，显示出每日一次的便利药丸为 PsO 患者提供完全皮肤清除的潜力。</p>
<p>该药物总体耐受性良好，副作用（AEs）与之前的研究一致，如上呼吸道感染、鼻咽炎和痤疮。</p>
<p>武田研发总裁安迪·普朗普博士表示：“看到我们的 II 期结果在 III 期中得到验证是非常令人振奋和激动的，超过一半的接受 zasocitinib 治疗的患者在第 16 周达到了清晰或几乎清晰的皮肤（PASI 90），约 30% 的患者达到了完全清晰的皮肤（PASI 100），反应率在第 24 周继续增加。”</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>根据试验结果，武田计划在 2026 年向 FDA 及其他监管机构提交新药申请（NDA）。这些数据也将在即将召开的医学大会上进行展示。</p>
<p>Zasocitinib 还在与 百时美施贵宝的 Sotyktu（deucravacitinib）进行头对头研究，涉及斑块型银屑病、银屑病关节炎的 III 期研究以及克罗恩病和溃疡性结肠炎的 II 期研究等其他适应症。</p>
<p>根据武田的说法，III 期研究的结果对截至 2026 年 3 月的财年全年的合并预测没有重大影响。</p>
<p>Zasocitinib 和 Sotyktu（后者于 2022 年 9 月获得批准）具有相同的分子靶点。GlobalData 的基于患者的预测估计 Sotyktu 将在 2025 年达到重磅药物的地位。到 2030 年，销售预计将达到 21.7 亿美元。</p>
<p>与此同时，根据同一基于患者的预测，zasocitinib 的销售预计到 2030 年将达到 12.8 亿美元。</p>
<p>强生（Johnson &amp; Johnson，J&amp;J）也希望在 PsO 市场上产生影响，其 研究药物 icotrokinra 显示出作为标准治疗（SoC）药物的潜力。</p>
<p>J&amp;J 已向 FDA 提交了该药物的 NDA，正在等待监管决定。</p>
<p>这正值 GlobalData 预测 PsO 药物销售 将在七个主要市场（7MM：美国、法国、德国、意大利、西班牙、英国和日本）到 2030 年达到 115.6 亿美元。</p>
<p>GlobalData 是《制药技术》的母公司。</p>
<h2>制药技术卓越奖 - 提名已关闭</h2>
<p>提名现已结束，感谢所有参与的组织——你们的响应非常出色，展示了卓越的创新、领导力和影响力。</p>
<p><strong>行动中的卓越</strong></p>
<p>Upperton Pharma Solutions 因在 综合制造 方面获得 2025 年制药技术卓越奖，正在迅速扩展其在英国的 GMP 和无菌制造能力。了解 Upperton 的综合 CDMO 模式如何帮助制药公司从早期开发阶段过渡到临床和小众商业供应，减少交接并加快时间进度。</p>
<p>发现影响</p>

4502

<p>武田制药计划在 2026 年向 FDA 提交其口服斑块状银屑病药物 zasocitinib 的新药申请，此前该药物成功完成了 III 期临床试验。试验显示该药物达到了所有主要和次要终点，且在疗效上优于安慰剂和 apremilast。Zasocitinib 还在与百时美施贵宝的 Sotyktu 以及其他疾病进行测试。该药物耐受性良好，副作用事件一致。武田的研发总裁对结果表示兴奋，这些结果验证了 II 期的发现</p>

<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/shutterstock_2193782839-1-430x241.jpg" alt="" original-src="https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/shutterstock_2193782839-1-430x241.jpg"/></p>
<p>Takeda plans to submit a new drug application (NDA) to the FDA and other regulatory authorities in 2026. Image credit:
Tada Images / Shutterstock.com.</p>
<div class="lb-trans"><p>武田计划在 2026 年向 FDA 及其他监管机构提交新药申请（NDA）。图片来源：Tada Images / Shutterstock.com。</p>
</div><p>Takeda’s once-daily oral plaque psoriasis (PsO) drug has met all its endpoints in two pivotal trials, with the company set to seek approval from the US Food and Drug Administration (FDA) in 2026.</p>
<div class="lb-trans"><p>武田的每日一次口服斑块型银屑病（PsO）药物在两项关键试验中达到了所有终点，预计将在 2026 年向美国食品药品监督管理局（FDA）申请批准。</p>
</div><p>In the randomised, multi-centre, double-blind, Phase III trials (NCT06088043 and NCT06108544), zasocitinib, an oral tyrosine kinase 2 (TYK2) inhibitor, met all its primary and secondary endpoints in adults with moderate-to-severe PsO.</p>
<div class="lb-trans"><p>在随机、多中心、双盲的 III 期试验（NCT06088043 和 NCT06108544）中，zasocitinib（一种口服酪氨酸激酶 2（TYK2）抑制剂）在中度至重度 PsO 成人患者中达到了所有主要和次要终点。</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 - GSK-2831781 in Plaque Psoriasis (Psoriasis Vul...</h4>
<div class="lb-trans"><h4>LOA 和 PTSR 模型 - GSK-2831781 在斑块型银屑病中的应用</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>
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<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 - IMP-731 in Plaque Psoriasis (Psoriasis Vulgaris)</h4>
<div class="lb-trans"><h4>LOA 和 PTSR 模型 - IMP-731 在斑块型银屑病中的应用</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>发现高效的 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>The studies, which were both placebo-controlled and active comparator-controlled, demonstrated superiority of zasocitinib compared to placebo in both static Physician Global Assessment (sPGA) 0/1 and Psoriasis Area and Severity Index (PASI) 75 after 16 weeks of treatment, with PASI 75 response rate seen as early as week four and continuing to increase through week 24.</p>
<div class="lb-trans"><p>这些研究均为安慰剂对照和活性对照，显示出 zasocitinib 在治疗 16 周后在静态医生全球评估（sPGA）0/1 和银屑病面积和严重指数（PASI）75 方面优于安慰剂，PASI 75 的反应率在第四周就已显现，并在第 24 周继续增加。</p>
</div><p>The studies also met all 44 ranked secondary endpoints, including PASI 90, PASI 100 and sPGA 0 against placebo and apremilast, showing the potential of a convenient once-daily pill to deliver complete skin clearance for patients with PsO.</p>
<div class="lb-trans"><p>研究还达到了所有 44 个排名的次要终点，包括 PASI 90、PASI 100 和 sPGA 0，相较于安慰剂和 apremilast，显示出每日一次的便利药丸为 PsO 患者提供完全皮肤清除的潜力。</p>
</div><p>The drug was generally well-tolerated, with adverse events (AEs) remaining consistent with prior studies, such as upper respiratory tract infection, nasopharyngitis and acne.</p>
<div class="lb-trans"><p>该药物总体耐受性良好，副作用（AEs）与之前的研究一致，如上呼吸道感染、鼻咽炎和痤疮。</p>
</div><p>Takeda R&amp;D president Dr Andy Plump said: “It is incredibly rewarding and exciting to see our Phase II results validated in Phase III, with more than half of patients treated with zasocitinib achieving clear or almost clear skin (PASI 90) and about 30 percent achieving completely clear skin (PASI 100) at week 16, with response rates continuing to increase through week 24.”</p>
<div class="lb-trans"><p>武田研发总裁安迪·普朗普博士表示：“看到我们的 II 期结果在 III 期中得到验证是非常令人振奋和激动的，超过一半的接受 zasocitinib 治疗的患者在第 16 周达到了清晰或几乎清晰的皮肤（PASI 90），约 30% 的患者达到了完全清晰的皮肤（PASI 100），反应率在第 24 周继续增加。”</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>Based on the trials, Takeda plans to submit a new drug application (NDA) to the FDA and other regulatory authorities in 2026. The data will also be presented at an upcoming medical congress.</p>
<div class="lb-trans"><p>根据试验结果，武田计划在 2026 年向 FDA 及其他监管机构提交新药申请（NDA）。这些数据也将在即将召开的医学大会上进行展示。</p>
</div><p>Zasocitinib is also being evaluated in a head-to-head study against Bristol Myers Squibb’s Sotyktu (deucravacitinib) in plaque psoriasis, Phase III studies in psoriatic arthritis and Phase II studies in Crohn’s disease and ulcerative colitis, among other indications.</p>
<div class="lb-trans"><p>Zasocitinib 还在与 百时美施贵宝的 Sotyktu（deucravacitinib）进行头对头研究，涉及斑块型银屑病、银屑病关节炎的 III 期研究以及克罗恩病和溃疡性结肠炎的 II 期研究等其他适应症。</p>
</div><p>According to Takeda, results from the Phase III studies have no significant impact on the full-year consolidated forecast for the fiscal year ending in March 2026.</p>
<div class="lb-trans"><p>根据武田的说法，III 期研究的结果对截至 2026 年 3 月的财年全年的合并预测没有重大影响。</p>
</div><p>Both zasocitinib and Sotyktu, the latter of which was approved in September 2022, have the same molecular target. GlobalData’s patient-based forecast estimates Sotyktu will reach blockbuster status in 2025. In 2030, sales are expected to reach $2.17bn.</p>
<div class="lb-trans"><p>Zasocitinib 和 Sotyktu（后者于 2022 年 9 月获得批准）具有相同的分子靶点。GlobalData 的基于患者的预测估计 Sotyktu 将在 2025 年达到重磅药物的地位。到 2030 年，销售预计将达到 21.7 亿美元。</p>
</div><p>Meanwhile, zasocitinib sales, according to the same patient-based forecast, are expected to reach $1.28bn in 2030.</p>
<div class="lb-trans"><p>与此同时，根据同一基于患者的预测，zasocitinib 的销售预计到 2030 年将达到 12.8 亿美元。</p>
</div><p>Johnson &amp; Johnson (J&amp;J) is also hoping to make an impact on the PsO market, with its investigational drug icotrokinra, which is showing potential as a standard of care (SoC) medication.</p>
<div class="lb-trans"><p>强生（Johnson &amp; Johnson，J&amp;J）也希望在 PsO 市场上产生影响，其 研究药物 icotrokinra 显示出作为标准治疗（SoC）药物的潜力。</p>
</div><p>J&amp;J has submitted an NDA to the FDA for approval of the drug and is awaiting a regulatory decision.</p>
<div class="lb-trans"><p>J&amp;J 已向 FDA 提交了该药物的 NDA，正在等待监管决定。</p>
</div><p>This comes as GlobalData predicts that PsO drug sales across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK and Japan) will reach $11.56bn in 2030.</p>
<div class="lb-trans"><p>这正值 GlobalData 预测 PsO 药物销售 将在七个主要市场（7MM：美国、法国、德国、意大利、西班牙、英国和日本）到 2030 年达到 115.6 亿美元。</p>
</div><p>GlobalData is the parent company of <em>Pharmaceutical Technology</em>.</p>
<div class="lb-trans"><p>GlobalData 是《制药技术》的母公司。</p>
</div><h2>Pharmaceutical Technology Excellence Awards - Nominations Closed</h2>
<div class="lb-trans"><h2>制药技术卓越奖 - 提名已关闭</h2>
</div><p>Nominations are now closed for the Pharmaceutical Technology Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact.</p>
<div class="lb-trans"><p>提名现已结束，感谢所有参与的组织——你们的响应非常出色，展示了卓越的创新、领导力和影响力。</p>
</div><p><strong>Excellence in Action</strong></p>
<div class="lb-trans"><p><strong>行动中的卓越</strong></p>
</div><p>Awarded the 2025 Pharmaceutical Technology Excellence Award for Business Expansion in Integrated Manufacturing, Upperton Pharma Solutions is rapidly expanding its UK GMP and sterile manufacturing footprint. Find out how Upperton’s integrated CDMO model helps pharma companies move from early development to clinical and niche commercial supply with fewer handovers and faster timelines.</p>
<div class="lb-trans"><p>Upperton Pharma Solutions 因在 综合制造 方面获得 2025 年制药技术卓越奖，正在迅速扩展其在英国的 GMP 和无菌制造能力。了解 Upperton 的综合 CDMO 模式如何帮助制药公司从早期开发阶段过渡到临床和小众商业供应，减少交接并加快时间进度。</p>
</div><p>Discover the Impact</p>
<div class="lb-trans"><p>发现影响</p>
</div>

武田制药计划基于三期临床试验数据，寻求斑块型银屑病口服药的批准