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<p>該試驗在第 48 周顯示出劑量依賴性結果，接受 2.4mg 治療的患者實現了 15.4% 的體重減輕。圖片來源：GBALLGIGGSPHOTO / Shutterstock.com。</p>
<p>Sciwind Biosciences 已獲得中國國家藥品監督管理局（NMPA）對其用於慢性體重管理的 Ecnoglutide 注射劑的批准。</p>
<p>Ecnoglutide 是一種環腺苷單磷酸（cAMP）偏向的類胰高血糖素肽-1（GLP-1）受體激動劑，旨在用於中國成年人的慢性體重管理，適用於肥胖或超重者。</p>
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<p>它以選擇性激活 cAMP 信號通路為特徵，減少β-逮捕蛋白的招募。這一機制使得有效且持續的體重減輕成為可能，同時支持代謝改善並最小化慢性疾病的風險。</p>
<p>Ecnoglutide 的批准基於一項於 2025 年 6 月在《柳葉刀糖尿病與內分泌學》上發表的第三階段臨牀試驗。</p>
<p>該試驗在第 48 周顯示出劑量依賴性結果，接受最高劑量（2.4mg）的患者平均體重減輕 15.4%（安慰劑調整後為 15.1%）。</p>
<p>此外，92.8% 的參與者實現了至少 5% 的體重減輕，許多人超過了 10% 或 15% 的減輕。體重減輕在 48 周內持續進行，沒有停滯。</p>
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<p>接受 Ecnoglutide 治療的參與者在心血管代謝風險因素方面也看到了顯著改善，例如血壓、空腹血糖、胰島素水平、糖化血紅蛋白（HbA1c）、胰島素抵抗的穩態模型評估（HOMA-IR）、脂質譜和腰圍。</p>
<p>該治療導致尿酸水平顯著降低，最高可達 54.3µmol/L，並減少了高尿酸血癥的發生率。</p>
<p>對於基線肝臟脂肪含量在 8% 或以上的患者，Ecnoglutide 在接受 2.4mg 劑量的患者中，在第 40 周實現了平均減少-53.1%。肝酶濃度的下降也超過了安慰劑組的記錄。</p>
<p>Sciwind Biosciences 創始人兼首席執行官潘海博士表示：“Ecnoglutide 注射劑在體重管理方面的批准是 Sciwind 在代謝疾病領域的重要里程碑，也是中國創新藥物在全球 GLP-1 領域的突破。”</p>
<p>“作為全球首個獲得批准的 cAMP 偏向 GLP-1 受體激動劑，Ecnoglutide 注射劑現已完成其在體重管理和 2 型糖尿病適應症方面的戰略定位。”</p>

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<p>Sciwind 已獲得中國國家藥品監督管理局（NMPA）對 Ecnoglutide 注射液的批准，這是一種針對肥胖成人的 GLP-1 受體激動劑，旨在進行慢性體重管理。該批准基於發表在《柳葉刀》上的第三階段臨牀試驗，結果顯示顯著的體重減輕和心代謝風險因素的改善。Ecnoglutide 在最高劑量下的平均體重減少為 15.4%，92.8% 的參與者至少減重 5%。Sciwind 的首席執行官強調，這是 GLP-1 領域創新藥物的一個里程碑</p>

<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/03/PT-2-09-03-2026-shutterstock_1161446392-430x241.jpg" alt="" original-src="https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/03/PT-2-09-03-2026-shutterstock_1161446392-430x241.jpg"/></p>
<p>The trial demonstrated dose-dependent results at week 48, with patients on 2.4mg achieving a 15.4% weight reduction. Credit: GBALLGIGGSPHOTO / Shutterstock.com.</p>
<div class="lb-trans"><p>該試驗在第 48 周顯示出劑量依賴性結果，接受 2.4mg 治療的患者實現了 15.4% 的體重減輕。圖片來源：GBALLGIGGSPHOTO / Shutterstock.com。</p>
</div><p>Sciwind Biosciences has received China’s National Medical Products Administration (NMPA) approval for its Ecnoglutide injection for chronic weight management.</p>
<div class="lb-trans"><p>Sciwind Biosciences 已獲得中國國家藥品監督管理局（NMPA）對其用於慢性體重管理的 Ecnoglutide 注射劑的批准。</p>
</div><p>Ecnoglutide is a cyclic adenosine monophosphate (cAMP)-biased glucagon-like peptide-1 (GLP-1) receptor agonist intended for chronic weight management in Chinese adults with obesity or who are overweight.</p>
<div class="lb-trans"><p>Ecnoglutide 是一種環腺苷單磷酸（cAMP）偏向的類胰高血糖素肽-1（GLP-1）受體激動劑，旨在用於中國成年人的慢性體重管理，適用於肥胖或超重者。</p>
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</div><h4>LOA and PTSR Model - Ecnoglutide in Obesity</h4>
<div class="lb-trans"><h4>LOA 和 PTSR 模型 - Ecnoglutide 在肥胖中的應用</h4>
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</div><h4>LOA and PTSR Model - Ecnoglutide in Type 2 Diabetes</h4>
<div class="lb-trans"><h4>LOA 和 PTSR 模型 - Ecnoglutide 在 2 型糖尿病中的應用</h4>
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</div><p>It is distinguished by its selective activation of the cAMP signalling pathway, reducing β-arrestin recruitment. This mechanism enables potent and sustained weight loss while supporting metabolic improvements and minimising the risk of chronic diseases.</p>
<div class="lb-trans"><p>它以選擇性激活 cAMP 信號通路為特徵，減少β-逮捕蛋白的招募。這一機制使得有效且持續的體重減輕成為可能，同時支持代謝改善並最小化慢性疾病的風險。</p>
</div><p>Ecnoglutide’s approval was based on a Phase III clinical trial that was published in <em>The Lancet Diabetes &amp; Endocrinology</em> in June 2025.</p>
<div class="lb-trans"><p>Ecnoglutide 的批准基於一項於 2025 年 6 月在《柳葉刀糖尿病與內分泌學》上發表的第三階段臨牀試驗。</p>
</div><p>The trial demonstrated dose-dependent results at week 48, where patients receiving the highest dose (2.4mg) achieved a mean 15.4% (placebo-adjusted 15.1%) reduction in weight.</p>
<div class="lb-trans"><p>該試驗在第 48 周顯示出劑量依賴性結果，接受最高劑量（2.4mg）的患者平均體重減輕 15.4%（安慰劑調整後為 15.1%）。</p>
</div><p>Furthermore, 92.8% of participants realised a weight loss of at least 5%, with many surpassing 10% or 15% reductions. Weight loss continued throughout 48 weeks without plateauing.</p>
<div class="lb-trans"><p>此外，92.8% 的參與者實現了至少 5% 的體重減輕，許多人超過了 10% 或 15% 的減輕。體重減輕在 48 周內持續進行，沒有停滯。</p>
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</div><p>Participants receiving Ecnoglutide also saw significant improvements across cardiometabolic risk factors such as blood pressure, fasting glucose, insulin levels, haemoglobin A1c (HbA1c), homeostatic model assessment of insulin resistance (HOMA-IR), lipid profile, and waist circumference.</p>
<div class="lb-trans"><p>接受 Ecnoglutide 治療的參與者在心血管代謝風險因素方面也看到了顯著改善，例如血壓、空腹血糖、胰島素水平、糖化血紅蛋白（HbA1c）、胰島素抵抗的穩態模型評估（HOMA-IR）、脂質譜和腰圍。</p>
</div><p>The treatment led to a notable decrease in uric acid levels, up to 54.3µmol/L, and reduced hyperuricaemia incidence.</p>
<div class="lb-trans"><p>該治療導致尿酸水平顯著降低，最高可達 54.3µmol/L，並減少了高尿酸血癥的發生率。</p>
</div><p>For those with baseline liver fat content of 8% or above, Ecnoglutide resulted in a mean reduction of -53.1% by week 40 among those on the 2.4mg dose. Liver enzyme concentrations also dropped more than those recorded in the placebo group.</p>
<div class="lb-trans"><p>對於基線肝臟脂肪含量在 8% 或以上的患者，Ecnoglutide 在接受 2.4mg 劑量的患者中，在第 40 周實現了平均減少-53.1%。肝酶濃度的下降也超過了安慰劑組的記錄。</p>
</div><p>Sciwind Biosciences founder and CEO Dr Hai Pan said: “The approval of Ecnoglutide injection for weight management is an important milestone for Sciwind in the metabolic disease area, and a breakthrough for China’s innovative drugs in the global GLP-1 field.</p>
<div class="lb-trans"><p>Sciwind Biosciences 創始人兼首席執行官潘海博士表示：“Ecnoglutide 注射劑在體重管理方面的批准是 Sciwind 在代謝疾病領域的重要里程碑，也是中國創新藥物在全球 GLP-1 領域的突破。”</p>
</div><p>“As the world’s first approved cAMP-biased GLP-1 receptor agonist, Ecnoglutide injection has now completed its strategic positioning for both weight management and type 2 diabetes indications.”</p>
<div class="lb-trans"><p>“作為全球首個獲得批准的 cAMP 偏向 GLP-1 受體激動劑，Ecnoglutide 注射劑現已完成其在體重管理和 2 型糖尿病適應症方面的戰略定位。”</p>
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Sciwind secures China’s NMPA approval for Ecnoglutide injection

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Sciwind 公司獲得了中國國家藥品監督管理局（NMPA）對 Ecnoglutide 注射液的批准