<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 結腸癌佔可切除病例的 15%，對化療反應較差。來源：NMK-Studio/Shutterstock.com。</p>
<p>藥明康德已獲得中國國家藥品監督管理局（NMPA）對 Tabosun（ipilimumab N01 注射液）的新藥申請（NDA）批准，該藥物為用於結腸癌的 CTLA-4 單克隆抗體。</p>
<p>該批准涵蓋其與 sintilimab 聯合使用，作為 IIB-III 期可切除微衞星不穩定高（MSI-H）或錯配修復缺陷（dMMR）結腸癌的新輔助治療。</p>
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<h4>LOA 和 PTSR 模型 - FPI-2059 在轉移性結直腸癌中的應用</h4>
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<h4>LOA 和 PTSR 模型 - FPI-2059 在轉移性前列腺癌中的應用</h4>
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<p>這標誌着聯合療法的一個重要監管里程碑，為中國的 MSI-H 或 dMMR 結腸癌患者提供了新的治療選擇。</p>
<p>短期的新輔助治療使用 ipilimumab N01 和 sintilimab 聯合治療顯示出病理完全緩解率的顯著改善，可能使更廣泛的 MSI-H/dMMR 結腸癌患者受益。</p>
<p>藥明康德表示，免疫檢查點抑制療法，包括 PD-1 和 CTLA-4 藥物，已經改變了癌症治療的格局。</p>
<p>ipilimumab N01 和 sintilimab 作為新輔助療法的聯合使用被發現顯著提高病理完全緩解率，並可能減少許多患者對輔助化療的需求。</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 戰略情報</p>
<h1>美國關税正在變化 - 你會反應還是預見？</h1>
<p>不要讓政策變化讓你措手不及。通過實時數據和專家分析保持主動。</p>
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<p>一項發表在《癌症細胞》雜誌上的 I 期臨牀試驗截至 2025 年 6 月 17 日招募了 101 名患者，並將其隨機分配接受 ipilimumab N01 加 sintilimab（n=52）或單獨接受 sintilimab（n=49）。</p>
<p>在符合方案的人羣中，聯合組的病理完全緩解率為 80%，而單獨使用 sintilimab 的組為 47.7%。在中位隨訪 21.4 個月內，兩組均未出現復發。</p>
<p>批准基於關鍵的 III 期 NeoShot 試驗，該試驗評估了新輔助 ipilimumab N01 和 sintilimab 與直接根治手術的療效和安全性。</p>
<p>主要終點包括無事件生存期和病理完全緩解率。獨立數據監測委員會（iDMC）的中期分析確認主要終點已達成。</p>
<h2>製藥技術卓越獎 - 提名已關閉</h2>
<p>製藥技術卓越獎 的提名現已關閉。感謝所有參與的組織 - 你們的回應非常出色，展示了卓越的創新、領導力和影響力。</p>
<p><strong>行動中的卓越</strong></p>
<p>Upperton Pharma Solutions 因在 綜合製造 方面的業務擴展獲得 2025 年製藥技術卓越獎，正在迅速擴大其在英國的 GMP 和無菌製造能力。瞭解 Upperton 的綜合 CDMO 模型如何幫助製藥公司從早期開發到臨牀和小眾商業供應，減少交接和加快時間。</p>
<p>發現影響</p>

信達生物

<p>信達生物已獲得中國國家藥品監督管理局（NMPA）對其 CTLA-4 單克隆抗體 Tabosun 用於治療結腸癌的批准。該批准允許其與信迪利單抗聯合使用，作為 IIB-III 期可切除 MSI-H 或 dMMR 結腸癌的新輔助治療。這種聯合療法在病理完全緩解率方面顯示出顯著改善，可能減少輔助化療的需求。該批准基於關鍵的 III 期 NeoShot 試驗結果，確認了該治療的有效性和安全性</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 結腸癌佔可切除病例的 15%，對化療反應較差。來源：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>藥明康德已獲得中國國家藥品監督管理局（NMPA）對 Tabosun（ipilimumab N01 注射液）的新藥申請（NDA）批准，該藥物為用於結腸癌的 CTLA-4 單克隆抗體。</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>該批准涵蓋其與 sintilimab 聯合使用，作為 IIB-III 期可切除微衞星不穩定高（MSI-H）或錯配修復缺陷（dMMR）結腸癌的新輔助治療。</p>
</div><h3>Go deeper with GlobalData</h3>
<div class="lb-trans"><h3>深入瞭解 GlobalData</h3>
</div><ul>
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</div><p>Reports</p>
<div class="lb-trans"><p>報告</p>
</div><h4>LOA and PTSR Model - FPI-2059 in Metastatic Colorectal Cancer</h4>
<div class="lb-trans"><h4>LOA 和 PTSR 模型 - FPI-2059 在轉移性結直腸癌中的應用</h4>
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</div><h4>LOA and PTSR Model - FPI-2059 in Metastatic Prostate Cancer</h4>
<div class="lb-trans"><h4>LOA 和 PTSR 模型 - FPI-2059 在轉移性前列腺癌中的應用</h4>
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<div class="lb-trans"><h5>深入瞭解 GlobalData</h5>
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<div class="lb-trans"><p>商業智能的黃金標準。</p>
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<div class="lb-trans"><h4>發現高效的 B2B 營銷</h4>
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<div class="lb-trans"><p>結合商業智能和編輯卓越，覆蓋 36 個領先媒體平台的專業人士。</p>
</div><p>Find out more</p>
<div class="lb-trans"><p>瞭解更多</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>這標誌着聯合療法的一個重要監管里程碑，為中國的 MSI-H 或 dMMR 結腸癌患者提供了新的治療選擇。</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>短期的新輔助治療使用 ipilimumab N01 和 sintilimab 聯合治療顯示出病理完全緩解率的顯著改善，可能使更廣泛的 MSI-H/dMMR 結腸癌患者受益。</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>藥明康德表示，免疫檢查點抑制療法，包括 PD-1 和 CTLA-4 藥物，已經改變了癌症治療的格局。</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 作為新輔助療法的聯合使用被發現顯著提高病理完全緩解率，並可能減少許多患者對輔助化療的需求。</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 戰略情報</p>
</div><h1>US Tariffs are shifting - will you react or anticipate?</h1>
<div class="lb-trans"><h1>美國關税正在變化 - 你會反應還是預見？</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>不要讓政策變化讓你措手不及。通過實時數據和專家分析保持主動。</p>
</div><p>By GlobalData</p>
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</div><p>Learn more about Strategic Intelligence</p>
<div class="lb-trans"><p>瞭解更多關於戰略情報</p>
</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>一項發表在《癌症細胞》雜誌上的 I 期臨牀試驗截至 2025 年 6 月 17 日招募了 101 名患者，並將其隨機分配接受 ipilimumab N01 加 sintilimab（n=52）或單獨接受 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>在符合方案的人羣中，聯合組的病理完全緩解率為 80%，而單獨使用 sintilimab 的組為 47.7%。在中位隨訪 21.4 個月內，兩組均未出現復發。</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>批准基於關鍵的 III 期 NeoShot 試驗，該試驗評估了新輔助 ipilimumab N01 和 sintilimab 與直接根治手術的療效和安全性。</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>主要終點包括無事件生存期和病理完全緩解率。獨立數據監測委員會（iDMC）的中期分析確認主要終點已達成。</p>
</div><h2>Pharmaceutical Technology Excellence Awards - Nominations Closed</h2>
<div class="lb-trans"><h2>製藥技術卓越獎 - 提名已關閉</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>製藥技術卓越獎 的提名現已關閉。感謝所有參與的組織 - 你們的回應非常出色，展示了卓越的創新、領導力和影響力。</p>
</div><p><strong>Excellence in Action</strong></p>
<div class="lb-trans"><p><strong>行動中的卓越</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 綜合製造 方面的業務擴展獲得 2025 年製藥技術卓越獎，正在迅速擴大其在英國的 GMP 和無菌製造能力。瞭解 Upperton 的綜合 CDMO 模型如何幫助製藥公司從早期開發到臨牀和小眾商業供應，減少交接和加快時間。</p>
</div><p>Discover the Impact</p>
<div class="lb-trans"><p>發現影響</p>
</div>

信達生物的 Tabosun 結腸癌治療方案獲得 NMPA 批准