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<p>Sobi 拥有在美国、加拿大和中国以外市场推广 Tryngolza 的独家权利。来源：瑞典孤儿生物制药公司。</p>
<p>Ionis Pharmaceuticals 和 Sobi 宣布 Tryngolza（olezarsen）在欧盟获得批准，用于治疗患有家族性乳糜微粒血症（FCS）的成年人。</p>
<p>FCS 是一种罕见的遗传疾病，导致甘油三酯水平极高，通常超过 880 mg/dL，而正常水平低于 150 mg/dL。</p>
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<h4>LOA 和 PTSR 模型 - AROAPOC-3 在高甘油三酯血症中的应用</h4>
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<p>Tryngolza 是一种靶向核糖核酸（RNA）的疗法，旨在减少 apoC-III 的产生，这是一种参与甘油三酯代谢的蛋白质。</p>
<p>该药物已在美国获得批准，并正在评估用于严重高甘油三酯血症（sHTG），其特征是空腹甘油三酯水平为 500mg/dL 或更高。</p>
<p>欧盟的批准是基于欧洲药品管理局人用药品委员会（CHMP）的积极推荐。</p>
<p>Ionis 首席执行官 Brett Monia 表示：“Tryngolza 在欧盟的批准是治疗 FCS 的重大进展。</p>
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<p>“Tryngolza 有潜力成为欧盟 FCS 患者的变革性治疗选择，他们面临着致残和危及生命的急性胰腺炎发作风险。</p>
<p>“我们很自豪能与 Sobi 合作，Sobi 是 Ionis 和 FCS 社区的长期合作伙伴，使 Tryngolza 能够在欧盟提供给 FCS 患者。”</p>
<p>欧盟的批准得到了 III 期 Balance 试验的数据支持，该试验评估了 olezarsen 在 FCS 患者中的疗效和安全性。</p>
<p>该疗法在六个月内显著降低了空腹甘油三酯水平，并在一年内维持了这一水平。</p>
<p>它还显示出急性胰腺炎事件的显著减少。</p>
<p>研究结果发表在《新英格兰医学杂志》上，表明 Tryngolza 具有良好的耐受性和安全性。</p>
<p>在 2025 年 3 月，Ionis 和 Sobi 签署了一项许可协议 以商业化 Tryngolza。</p>
<p>Sobi 拥有在美国、加拿大和中国以外市场推广该药物的独家权利。</p>
<h2>制药技术卓越奖 - 参赛的好处</h2>
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Ionis制药

<p>Ionis 制药和 Sobi 已获得欧盟批准，允许使用 Tryngolza（olezarsen）治疗患有家族性乳糜微粒血症（FCS）的成年人，这是一种导致高甘油三酯水平的罕见遗传疾病。Sobi 将在美国、加拿大和中国以外的地区销售该药物。此次批准是基于欧洲药品管理局的积极推荐，并依据 III 期临床试验数据，显示甘油三酯水平和急性胰腺炎事件显著减少。Ionis 首席执行官 Brett Monia 强调了该治疗在欧盟为 FCS 患者转变护理的潜力</p>

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<p>Sobi holds exclusive rights to market Tryngolza outside the US, Canada and China. Credit: Swedish Orphan Biovitrum AB.</p>
<div class="lb-trans"><p>Sobi 拥有在美国、加拿大和中国以外市场推广 Tryngolza 的独家权利。来源：瑞典孤儿生物制药公司。</p>
</div><p>Ionis Pharmaceuticals and Sobi have announced the approval of Tryngolza (olezarsen) in the European Union (EU) for adults with familial chylomicronemia syndrome (FCS).</p>
<div class="lb-trans"><p>Ionis Pharmaceuticals 和 Sobi 宣布 Tryngolza（olezarsen）在欧盟获得批准，用于治疗患有家族性乳糜微粒血症（FCS）的成年人。</p>
</div><p>FCS is a rare genetic condition that leads to extremely high triglyceride levels, often exceeding 880 mg/dL, compared to normal levels below 150 mg/dL.</p>
<div class="lb-trans"><p>FCS 是一种罕见的遗传疾病，导致甘油三酯水平极高，通常超过 880 mg/dL，而正常水平低于 150 mg/dL。</p>
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<div class="lb-trans"><h4>LOA 和 PTSR 模型 - AROAPOC-3 在高甘油三酯血症中的应用</h4>
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</div><p>Tryngolza is a ribonucleic acid (RNA)-targeted therapy designed to reduce the production of apoC-III, a protein involved in triglyceride metabolism.</p>
<div class="lb-trans"><p>Tryngolza 是一种靶向核糖核酸（RNA）的疗法，旨在减少 apoC-III 的产生，这是一种参与甘油三酯代谢的蛋白质。</p>
</div><p>It is already approved in the US and is also under evaluation for severe hypertriglyceridemia (sHTG), characterised by fasting triglyceride levels of 500mg/dL or higher.</p>
<div class="lb-trans"><p>该药物已在美国获得批准，并正在评估用于严重高甘油三酯血症（sHTG），其特征是空腹甘油三酯水平为 500mg/dL 或更高。</p>
</div><p>The EU approval follows a favourable recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).</p>
<div class="lb-trans"><p>欧盟的批准是基于欧洲药品管理局人用药品委员会（CHMP）的积极推荐。</p>
</div><p>Ionis CEO Brett Monia stated: “The EU approval of Tryngolza is a significant advance for the treatment of FCS.</p>
<div class="lb-trans"><p>Ionis 首席执行官 Brett Monia 表示：“Tryngolza 在欧盟的批准是治疗 FCS 的重大进展。</p>
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</div><p>“Tryngolza has the potential to be a transformative treatment option for FCS patients in the EU who are at risk of debilitating and life-threatening acute pancreatitis attacks.</p>
<div class="lb-trans"><p>“Tryngolza 有潜力成为欧盟 FCS 患者的变革性治疗选择，他们面临着致残和危及生命的急性胰腺炎发作风险。</p>
</div><p>“We are proud to work with Sobi, a long-standing partner of Ionis and the FCS community, to make Tryngolza available to people with FCS in the EU.”</p>
<div class="lb-trans"><p>“我们很自豪能与 Sobi 合作，Sobi 是 Ionis 和 FCS 社区的长期合作伙伴，使 Tryngolza 能够在欧盟提供给 FCS 患者。”</p>
</div><p>The EU approval is supported by data from the Phase III Balance trial, which evaluated the efficacy and safety of olezarsen in FCS patients.</p>
<div class="lb-trans"><p>欧盟的批准得到了 III 期 Balance 试验的数据支持，该试验评估了 olezarsen 在 FCS 患者中的疗效和安全性。</p>
</div><p>The therapy showed significant reductions in fasting triglyceride levels at six months and maintained them over a year.</p>
<div class="lb-trans"><p>该疗法在六个月内显著降低了空腹甘油三酯水平，并在一年内维持了这一水平。</p>
</div><p>It also showed a significant decrease in acute pancreatitis incidents.</p>
<div class="lb-trans"><p>它还显示出急性胰腺炎事件的显著减少。</p>
</div><p>Results from the study, published in <em>The New England Journal of Medicine,</em> indicated a favourable tolerability and safety profile for Tryngolza.</p>
<div class="lb-trans"><p>研究结果发表在《新英格兰医学杂志》上，表明 Tryngolza 具有良好的耐受性和安全性。</p>
</div><p>In March 2025, Ionis and Sobi entered a licence agreement for the commercialisation of Tryngolza.</p>
<div class="lb-trans"><p>在 2025 年 3 月，Ionis 和 Sobi 签署了一项许可协议 以商业化 Tryngolza。</p>
</div><p>Sobi holds exclusive rights to market the drug outside the US, Canada and China.</p>
<div class="lb-trans"><p>Sobi 拥有在美国、加拿大和中国以外市场推广该药物的独家权利。</p>
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<div class="lb-trans"><h2>制药技术卓越奖 - 参赛的好处</h2>
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<div class="lb-trans"><p>获得你应得的认可！制药技术卓越奖 庆祝创新、领导力和影响力。通过参赛，你展示了你的成就，提高了你的行业形象，并将自己定位于推动制药进步的顶尖领导者之中。不要错过脱颖而出的机会——今天就提交你的参赛作品！</p>
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Ionis 制药和 Sobi 公司的 Tryngolza 获得欧盟批准用于治疗家族性乳糜微粒血症（FCS）