<p><img src="https://imageproxy.pbkrs.com/https://www.worldpharmaceuticals.net/wp-content/uploads/sites/12/2026/03/CTA-04-03-2026-shutterstock_341007092-428x241.jpg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" width="428" height="241" original-src="https://imageproxy.pbkrs.com/https://www.worldpharmaceuticals.net/wp-content/uploads/sites/12/2026/03/CTA-04-03-2026-shutterstock_341007092-428x241.jpg"/></p>
<p>研究结果表明与 OX40 通路调节可能存在潜在的机制联系。来源：实验室照片 / Shutterstock.com。</p>
<p>Kyowa Kirin 宣布全球停止所有正在进行的 rocatinlimab 临床试验，该药物是一种正在研究用于中重度特应性皮炎（AD）、结节性瘙痒和中重度哮喘的抗 OX40 单克隆抗体。</p>
<p>暂停 rocatinlimab 临床试验计划的决定是在计划的安全性审查之后做出的。</p>
<p>来自全球临床项目的最新安全性更新使 Kyowa Kirin 和 Amgen 得出结论，潜在风险可能超过所研究患者群体的益处。</p>
<p><img src="https://imageproxy.pbkrs.com/https://hubspot-pmisites.pantheonsite.io/techmonitor/wp-content/themes/goodlife-wp-B2B/assets/images/icons/Module.png?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" width="130" height="183" original-src="https://imageproxy.pbkrs.com/https://hubspot-pmisites.pantheonsite.io/techmonitor/wp-content/themes/goodlife-wp-B2B/assets/images/icons/Module.png"/></p>
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<p>本次评估考虑了新出现的安全信息，包括之前报告的风险。</p>
<p>在过去几周内，安全性审查引发了对可能与病毒或免疫相关机制相关的恶性肿瘤的担忧。审查确认了一个新的确诊病例和一个疑似病例，此外还有一个之前确认的病例。</p>
<p>这些发现表明与 OX40 通路调节可能存在潜在的机制联系。尽管总体恶性肿瘤的数量仍低于预期的背景水平，但这些病例的特征呈现出一个不容忽视的生物学关注点。</p>
<p>Kyowa Kirin 的总裁兼首席运营官 Abdul Mullick 表示：“这是一个令人深感失望的消息，因为我们希望能为患者提供安全有效的治疗。Rocatinlimab 在 ROCKET 项目中显示出对中重度特应性皮炎的持久和临床意义的疗效。</p>
<p>“然而，安全性特征已经发生变化，患者安全仍然是我们的最高优先事项，因此我们采取了这一果断而谨慎的步骤。”</p>
<p>Kyowa Kirin 和 Amgen 正在通知监管机构和试验研究人员这一决定。</p>
<p>所有研究将在参与者完成所需的安全随访访问后正式终止。两家公司将共同分析完整的数据集，并计划在数据评估完成后提供进一步的更新。</p>
<p>在 2025 年 9 月，Amgen 和 Kyowa Kirin 宣布了 rocatinlimab 治疗中重度 AD 的 III 期 ASCEND 试验的初步顶线结果。</p>
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医疗业 ETF - Vanguard

基因改革 ETF - ARK

纽交所高增长板生物技术指数 ETF - First Trust

<p>Kyowa Kirin 宣布全球停止所有正在进行的 rocatinlimab 临床试验，这是一种抗 OX40 单克隆抗体。此决定是在安全性审查后做出的，该审查提出了关于潜在风险的担忧，包括与该治疗相关的恶性肿瘤。尽管在中度至重度特应性皮炎方面之前显示出疗效，但不断变化的安全性特征导致得出风险可能超过收益的结论。Kyowa Kirin 和 Amgen 将在完成安全性跟踪后通知监管机构并终止研究</p>

<p><img src="https://imageproxy.pbkrs.com/https://www.worldpharmaceuticals.net/wp-content/uploads/sites/12/2026/03/CTA-04-03-2026-shutterstock_341007092-428x241.jpg" alt="" original-src="https://www.worldpharmaceuticals.net/wp-content/uploads/sites/12/2026/03/CTA-04-03-2026-shutterstock_341007092-428x241.jpg"/></p>
<p>The findings suggest a potential mechanistic connection to OX40 pathway modulation. Credit: Lab Photo / Shutterstock.com.</p>
<div class="lb-trans"><p>研究结果表明与 OX40 通路调节可能存在潜在的机制联系。来源：实验室照片 / Shutterstock.com。</p>
</div><p>Kyowa Kirin has announced the global discontinuation of all ongoing clinical trials for rocatinlimab, an anti-OX40 monoclonal antibody under investigation for moderate-to-severe atopic dermatitis (AD), prurigo nodularis, and moderate-to-severe asthma.</p>
<div class="lb-trans"><p>Kyowa Kirin 宣布全球停止所有正在进行的 rocatinlimab 临床试验，该药物是一种正在研究用于中重度特应性皮炎（AD）、结节性瘙痒和中重度哮喘的抗 OX40 单克隆抗体。</p>
</div><p>The decision to suspend the rocatinlimab clinical trial programme follows a planned safety review.</p>
<div class="lb-trans"><p>暂停 rocatinlimab 临床试验计划的决定是在计划的安全性审查之后做出的。</p>
</div><p>The recent safety update from the global clinical programme led Kyowa Kirin and Amgen to conclude that potential risks may outweigh the benefits for the patient populations studied.</p>
<div class="lb-trans"><p>来自全球临床项目的最新安全性更新使 Kyowa Kirin 和 Amgen 得出结论，潜在风险可能超过所研究患者群体的益处。</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://hubspot-pmisites.pantheonsite.io/techmonitor/wp-content/themes/goodlife-wp-B2B/assets/images/icons/Module.png" alt="" original-src="https://hubspot-pmisites.pantheonsite.io/techmonitor/wp-content/themes/goodlife-wp-B2B/assets/images/icons/Module.png"/></p>
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</div><p>This assessment considered emerging safety information, which included previously reported risks.</p>
<div class="lb-trans"><p>本次评估考虑了新出现的安全信息，包括之前报告的风险。</p>
</div><p>Over the past several weeks, a safety review raised concerns about malignancies possibly linked to viral or immune-related mechanisms. The review identified one new confirmed case and one suspected case of Kaposi’s sarcoma, besides a previously confirmed case.</p>
<div class="lb-trans"><p>在过去几周内，安全性审查引发了对可能与病毒或免疫相关机制相关的恶性肿瘤的担忧。审查确认了一个新的确诊病例和一个疑似病例，此外还有一个之前确认的病例。</p>
</div><p>These findings suggest a potential mechanistic connection to OX40 pathway modulation. Although the overall number of malignancies is still lower than anticipated background levels, the attributes of these cases present a plausible biological concern that cannot be disregarded.</p>
<div class="lb-trans"><p>这些发现表明与 OX40 通路调节可能存在潜在的机制联系。尽管总体恶性肿瘤的数量仍低于预期的背景水平，但这些病例的特征呈现出一个不容忽视的生物学关注点。</p>
</div><p>Kyowa Kirin’s president and chief operating officer Abdul Mullick said: “This is deeply disappointing news, as we had hoped to bring a safe and effective treatment to patients. Rocatinlimab has demonstrated durable and clinically meaningful efficacy in moderate-to-severe atopic dermatitis in the ROCKET programme.</p>
<div class="lb-trans"><p>Kyowa Kirin 的总裁兼首席运营官 Abdul Mullick 表示：“这是一个令人深感失望的消息，因为我们希望能为患者提供安全有效的治疗。Rocatinlimab 在 ROCKET 项目中显示出对中重度特应性皮炎的持久和临床意义的疗效。</p>
</div><p>“However, the safety profile has evolved, and as patient safety remains our highest priority, we have taken this decisive and cautious step.”</p>
<div class="lb-trans"><p>“然而，安全性特征已经发生变化，患者安全仍然是我们的最高优先事项，因此我们采取了这一果断而谨慎的步骤。”</p>
</div><p>Both Kyowa Kirin and Amgen are notifying regulatory authorities and trial investigators about the decision.</p>
<div class="lb-trans"><p>Kyowa Kirin 和 Amgen 正在通知监管机构和试验研究人员这一决定。</p>
</div><p>All studies will be formally terminated after participants complete the required safety follow-up visits. The companies will jointly analyse the full dataset and plan to provide further updates after data assessments are completed.</p>
<div class="lb-trans"><p>所有研究将在参与者完成所需的安全随访访问后正式终止。两家公司将共同分析完整的数据集，并计划在数据评估完成后提供进一步的更新。</p>
</div><p>In September 2025, Amgen and Kyowa Kirin announced initial top line findings from the Phase III ASCEND trial of rocatinlimab for treating adults and adolescents with moderate to severe AD.</p>
<div class="lb-trans"><p>在 2025 年 9 月，Amgen 和 Kyowa Kirin 宣布了 rocatinlimab 治疗中重度 AD 的 III 期 ASCEND 试验的初步顶线结果。</p>
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协和麒麟停止了正在进行的罗卡替尼利单抗试验