<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/PT-29-12-2025-shutterstock_2518449681-430x241.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/PT-29-12-2025-shutterstock_2518449681-430x241.jpg"/></p>
<p>MSI-H/dMMR 结肠癌占可切除病例的 15%，对化疗反应较差。来源：NMK-Studio/Shutterstock.com。</p>
<p>药明康德已获得中国国家药品监督管理局（NMPA）对 Tabosun（ipilimumab N01 注射液）的新药申请（NDA）批准，该药物为用于结肠癌的 CTLA-4 单克隆抗体。</p>
<p>该批准涵盖其与 sintilimab 联合使用，作为 IIB-III 期可切除微卫星不稳定高（MSI-H）或错配修复缺陷（dMMR）结肠癌的新辅助治疗。</p>
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<h4>LOA 和 PTSR 模型 - FPI-2059 在转移性结直肠癌中的应用</h4>
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<h4>LOA 和 PTSR 模型 - FPI-2059 在转移性前列腺癌中的应用</h4>
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<p>这标志着联合疗法的一个重要监管里程碑，为中国的 MSI-H 或 dMMR 结肠癌患者提供了新的治疗选择。</p>
<p>短期的新辅助治疗使用 ipilimumab N01 和 sintilimab 联合治疗显示出病理完全缓解率的显著改善，可能使更广泛的 MSI-H/dMMR 结肠癌患者受益。</p>
<p>药明康德表示，免疫检查点抑制疗法，包括 PD-1 和 CTLA-4 药物，已经改变了癌症治疗的格局。</p>
<p>ipilimumab N01 和 sintilimab 作为新辅助疗法的联合使用被发现显著提高病理完全缓解率，并可能减少许多患者对辅助化疗的需求。</p>
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<h1>美国关税正在变化 - 你会反应还是预见？</h1>
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<p>一项发表在《癌症细胞》杂志上的 I 期临床试验截至 2025 年 6 月 17 日招募了 101 名患者，并将其随机分配接受 ipilimumab N01 加 sintilimab（n=52）或单独接受 sintilimab（n=49）。</p>
<p>在符合方案的人群中，联合组的病理完全缓解率为 80%，而单独使用 sintilimab 的组为 47.7%。在中位随访 21.4 个月内，两组均未出现复发。</p>
<p>批准基于关键的 III 期 NeoShot 试验，该试验评估了新辅助 ipilimumab N01 和 sintilimab 与直接根治手术的疗效和安全性。</p>
<p>主要终点包括无事件生存期和病理完全缓解率。独立数据监测委员会（iDMC）的中期分析确认主要终点已达成。</p>
<h2>制药技术卓越奖 - 提名已关闭</h2>
<p>制药技术卓越奖 的提名现已关闭。感谢所有参与的组织 - 你们的回应非常出色，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 方面的业务扩展获得 2025 年制药技术卓越奖，正在迅速扩大其在英国的 GMP 和无菌制造能力。了解 Upperton 的综合 CDMO 模型如何帮助制药公司从早期开发到临床和小众商业供应，减少交接和加快时间。</p>
<p>发现影响</p>

信达生物

<p>信达生物已获得中国国家药品监督管理局（NMPA）对其 CTLA-4 单克隆抗体 Tabosun 用于治疗结肠癌的批准。该批准允许其与信迪利单抗联合使用，作为 IIB-III 期可切除 MSI-H 或 dMMR 结肠癌的新辅助治疗。这种联合疗法在病理完全缓解率方面显示出显著改善，可能减少辅助化疗的需求。该批准基于关键的 III 期 NeoShot 试验结果，确认了该治疗的有效性和安全性</p>

<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/PT-29-12-2025-shutterstock_2518449681-430x241.jpg" alt="" original-src="https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/PT-29-12-2025-shutterstock_2518449681-430x241.jpg"/></p>
<p>MSI-H/dMMR colon cancer comprises 15% of resectable cases and responds poorly to chemotherapy. Credit: NMK-Studio/Shutterstock.com.</p>
<div class="lb-trans"><p>MSI-H/dMMR 结肠癌占可切除病例的 15%，对化疗反应较差。来源：NMK-Studio/Shutterstock.com。</p>
</div><p>Innovent Biologics has received China’s National Medical Products Administration (NMPA) approval for the New Drug Application (NDA) for Tabosun (ipilimumab N01 injection), a CTLA-4 monoclonal antibody for colon cancer.</p>
<div class="lb-trans"><p>药明康德已获得中国国家药品监督管理局（NMPA）对 Tabosun（ipilimumab N01 注射液）的新药申请（NDA）批准，该药物为用于结肠癌的 CTLA-4 单克隆抗体。</p>
</div><p>The approval covers its use in combination with sintilimab as a neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer.</p>
<div class="lb-trans"><p>该批准涵盖其与 sintilimab 联合使用，作为 IIB-III 期可切除微卫星不稳定高（MSI-H）或错配修复缺陷（dMMR）结肠癌的新辅助治疗。</p>
</div><h3>Go deeper with GlobalData</h3>
<div class="lb-trans"><h3>深入了解 GlobalData</h3>
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<div class="lb-trans"><h4>LOA 和 PTSR 模型 - FPI-2059 在转移性结直肠癌中的应用</h4>
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<div class="lb-trans"><h4>LOA 和 PTSR 模型 - FPI-2059 在转移性前列腺癌中的应用</h4>
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<div class="lb-trans"><p>了解更多</p>
</div><p>This marks a significant regulatory milestone for the combination therapy, providing a new treatment option for patients with MSI-H or dMMR colon cancer in China.</p>
<div class="lb-trans"><p>这标志着联合疗法的一个重要监管里程碑，为中国的 MSI-H 或 dMMR 结肠癌患者提供了新的治疗选择。</p>
</div><p>Short-term neoadjuvant treatment with the ipilimumab N01 and sintilimab combination has shown a substantial improvement in pathological complete response rate, potentially benefiting a wider group of patients with MSI-H/dMMR colon cancer.</p>
<div class="lb-trans"><p>短期的新辅助治疗使用 ipilimumab N01 和 sintilimab 联合治疗显示出病理完全缓解率的显著改善，可能使更广泛的 MSI-H/dMMR 结肠癌患者受益。</p>
</div><p>Innovent stated that immune checkpoint blockade therapies, including PD-1 and CTLA-4 agents, have changed the landscape of cancer treatment.</p>
<div class="lb-trans"><p>药明康德表示，免疫检查点抑制疗法，包括 PD-1 和 CTLA-4 药物，已经改变了癌症治疗的格局。</p>
</div><p>The combination of ipilimumab N01 and sintilimab as a neoadjuvant therapy has been found to significantly improve pathological complete response rates and may reduce the need for adjuvant chemotherapy in many patients.</p>
<div class="lb-trans"><p>ipilimumab N01 和 sintilimab 作为新辅助疗法的联合使用被发现显著提高病理完全缓解率，并可能减少许多患者对辅助化疗的需求。</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>
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</div><p>A Phase Ib trial published in the Cancer Cell journal enrolled 101 patients as of 17 June 2025 and randomised them to receive ipilimumab N01 plus sintilimab (n=52) or sintilimab alone (n=49).</p>
<div class="lb-trans"><p>一项发表在《癌症细胞》杂志上的 I 期临床试验截至 2025 年 6 月 17 日招募了 101 名患者，并将其随机分配接受 ipilimumab N01 加 sintilimab（n=52）或单独接受 sintilimab（n=49）。</p>
</div><p>In the per-protocol population, the pathological complete response rate was 80% in the combination arm compared to 47.7% with sintilimab alone. Neither group experienced recurrence over a median follow-up of 21.4 months.</p>
<div class="lb-trans"><p>在符合方案的人群中，联合组的病理完全缓解率为 80%，而单独使用 sintilimab 的组为 47.7%。在中位随访 21.4 个月内，两组均未出现复发。</p>
</div><p>Approval was based on the pivotal Phase III NeoShot trial, which assessed efficacy and safety for neoadjuvant ipilimumab N01 and sintilimab versus direct radical surgery.</p>
<div class="lb-trans"><p>批准基于关键的 III 期 NeoShot 试验，该试验评估了新辅助 ipilimumab N01 和 sintilimab 与直接根治手术的疗效和安全性。</p>
</div><p>Primary endpoints included event-free survival and pathological complete response rate. Interim analysis by the Independent Data Monitoring Committee (iDMC) confirmed the primary endpoint was met.</p>
<div class="lb-trans"><p>主要终点包括无事件生存期和病理完全缓解率。独立数据监测委员会（iDMC）的中期分析确认主要终点已达成。</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>制药技术卓越奖 的提名现已关闭。感谢所有参与的组织 - 你们的回应非常出色，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 方面的业务扩展获得 2025 年制药技术卓越奖，正在迅速扩大其在英国的 GMP 和无菌制造能力。了解 Upperton 的综合 CDMO 模型如何帮助制药公司从早期开发到临床和小众商业供应，减少交接和加快时间。</p>
</div><p>Discover the Impact</p>
<div class="lb-trans"><p>发现影响</p>
</div>

信达生物的 Tabosun 结肠癌治疗方案获得 NMPA 批准