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<p>该试验在第 48 周显示出剂量依赖性结果，接受 2.4mg 治疗的患者实现了 15.4% 的体重减轻。图片来源：GBALLGIGGSPHOTO / Shutterstock.com。</p>
<p>Sciwind Biosciences 已获得中国国家药品监督管理局（NMPA）对其用于慢性体重管理的 Ecnoglutide 注射剂的批准。</p>
<p>Ecnoglutide 是一种环腺苷单磷酸（cAMP）偏向的类胰高血糖素肽-1（GLP-1）受体激动剂，旨在用于中国成年人的慢性体重管理，适用于肥胖或超重者。</p>
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<h4>LOA 和 PTSR 模型 - Ecnoglutide 在肥胖中的应用</h4>
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<p>它以选择性激活 cAMP 信号通路为特征，减少β-逮捕蛋白的招募。这一机制使得有效且持续的体重减轻成为可能，同时支持代谢改善并最小化慢性疾病的风险。</p>
<p>Ecnoglutide 的批准基于一项于 2025 年 6 月在《柳叶刀糖尿病与内分泌学》上发表的第三阶段临床试验。</p>
<p>该试验在第 48 周显示出剂量依赖性结果，接受最高剂量（2.4mg）的患者平均体重减轻 15.4%（安慰剂调整后为 15.1%）。</p>
<p>此外，92.8% 的参与者实现了至少 5% 的体重减轻，许多人超过了 10% 或 15% 的减轻。体重减轻在 48 周内持续进行，没有停滞。</p>
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<p>接受 Ecnoglutide 治疗的参与者在心血管代谢风险因素方面也看到了显著改善，例如血压、空腹血糖、胰岛素水平、糖化血红蛋白（HbA1c）、胰岛素抵抗的稳态模型评估（HOMA-IR）、脂质谱和腰围。</p>
<p>该治疗导致尿酸水平显著降低，最高可达 54.3µmol/L，并减少了高尿酸血症的发生率。</p>
<p>对于基线肝脏脂肪含量在 8% 或以上的患者，Ecnoglutide 在接受 2.4mg 剂量的患者中，在第 40 周实现了平均减少-53.1%。肝酶浓度的下降也超过了安慰剂组的记录。</p>
<p>Sciwind Biosciences 创始人兼首席执行官潘海博士表示：“Ecnoglutide 注射剂在体重管理方面的批准是 Sciwind 在代谢疾病领域的重要里程碑，也是中国创新药物在全球 GLP-1 领域的突破。”</p>
<p>“作为全球首个获得批准的 cAMP 偏向 GLP-1 受体激动剂，Ecnoglutide 注射剂现已完成其在体重管理和 2 型糖尿病适应症方面的战略定位。”</p>

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<p>Sciwind 已获得中国国家药品监督管理局（NMPA）对 Ecnoglutide 注射液的批准，这是一种针对肥胖成人的 GLP-1 受体激动剂，旨在进行慢性体重管理。该批准基于发表在《柳叶刀》上的第三阶段临床试验，结果显示显著的体重减轻和心代谢风险因素的改善。Ecnoglutide 在最高剂量下的平均体重减少为 15.4%，92.8% 的参与者至少减重 5%。Sciwind 的首席执行官强调，这是 GLP-1 领域创新药物的一个里程碑</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>该试验在第 48 周显示出剂量依赖性结果，接受 2.4mg 治疗的患者实现了 15.4% 的体重减轻。图片来源：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 已获得中国国家药品监督管理局（NMPA）对其用于慢性体重管理的 Ecnoglutide 注射剂的批准。</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 是一种环腺苷单磷酸（cAMP）偏向的类胰高血糖素肽-1（GLP-1）受体激动剂，旨在用于中国成年人的慢性体重管理，适用于肥胖或超重者。</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 在肥胖中的应用</h4>
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<div class="lb-trans"><h4>LOA 和 PTSR 模型 - Ecnoglutide 在 2 型糖尿病中的应用</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>它以选择性激活 cAMP 信号通路为特征，减少β-逮捕蛋白的招募。这一机制使得有效且持续的体重减轻成为可能，同时支持代谢改善并最小化慢性疾病的风险。</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 的批准基于一项于 2025 年 6 月在《柳叶刀糖尿病与内分泌学》上发表的第三阶段临床试验。</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>该试验在第 48 周显示出剂量依赖性结果，接受最高剂量（2.4mg）的患者平均体重减轻 15.4%（安慰剂调整后为 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% 的参与者实现了至少 5% 的体重减轻，许多人超过了 10% 或 15% 的减轻。体重减轻在 48 周内持续进行，没有停滞。</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 治疗的参与者在心血管代谢风险因素方面也看到了显著改善，例如血压、空腹血糖、胰岛素水平、糖化血红蛋白（HbA1c）、胰岛素抵抗的稳态模型评估（HOMA-IR）、脂质谱和腰围。</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>该治疗导致尿酸水平显著降低，最高可达 54.3µmol/L，并减少了高尿酸血症的发生率。</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>对于基线肝脏脂肪含量在 8% 或以上的患者，Ecnoglutide 在接受 2.4mg 剂量的患者中，在第 40 周实现了平均减少-53.1%。肝酶浓度的下降也超过了安慰剂组的记录。</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 创始人兼首席执行官潘海博士表示：“Ecnoglutide 注射剂在体重管理方面的批准是 Sciwind 在代谢疾病领域的重要里程碑，也是中国创新药物在全球 GLP-1 领域的突破。”</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>“作为全球首个获得批准的 cAMP 偏向 GLP-1 受体激动剂，Ecnoglutide 注射剂现已完成其在体重管理和 2 型糖尿病适应症方面的战略定位。”</p>
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Sciwind secures China’s NMPA approval for Ecnoglutide injection

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Sciwind 公司获得了中国国家药品监督管理局（NMPA）对 Ecnoglutide 注射液的批准