<ul>
<li><em>协议强调了 Norgine 的使命，即为患者带来创新疗法，并基于我们在肝病学和专业药品领域的传统。</em></li>
<li><em>Vir Biotechnology 的慢性肝炎δ治疗候选药物显示出强劲的病毒学反应，反映出一种差异化的治疗方法。</em></li>
</ul>
<p>, /PRNewswire/ -- Norgine，一家领先的欧洲专业制药公司，今天宣布了一项独家许可协议，根据该协议，Norgine 将在获得必要的市场授权后，在欧洲、澳大利亚和新西兰商业化 tobevibart 和 elebsiran 的组合用于治疗慢性肝炎δ（CHD）。由于现有治疗选择的潜在局限性，CHD 对有效治疗的需求非常迫切。</p>
<p>根据许可协议的条款，Vir Biotechnology 将获得 5500 万欧元的初始补偿款，以及最多 4.95 亿欧元的潜在监管和商业里程碑付款。此外，Vir Biotechnology 将在 Norgine 的许可区域内获得净销售额的中等青少年到高二十几的百分比的分级版税。Vir Biotechnology 在其 ECLIPSE 注册项目（ECLIPSE 1、2 和 3）中进行的临床开发费用将由双方分担，Norgine 将承担一定比例的后续外部费用。Norgine 将负责所有商业化活动，并将在其许可区域内持有所有市场授权。该交易在美国以外某些司法管辖区的完成取决于 Norgine 获得相关当局的监管批准。</p>
<p>&#34;Norgine 在肝病学和专业护理方面有着丰富的历史，这笔交易代表了一个高度创新和协同的产品组合，继续巩固我们在这一领域的强大立足点，&#34; Norgine 首席执行官 Janneke van der Kamp 表示。&#34;通过将我们经过验证的商业和区域专业知识与 Vir Biotechnology 的前沿科学相结合，我们正在加强我们改善医疗保健结果的承诺。像这样的合作关系确认了 Norgine 作为寻求在欧洲、澳大利亚和新西兰找到可信赖合作伙伴的公司的首选合作伙伴的地位。&#34;</p>
<p>&#34;这项合作增强了我们为需要有效、安全和便捷治疗选择的慢性肝炎δ患者提供这一重要疗法的能力，&#34; Vir Biotechnology 首席执行官 Marianne De Backer，M.Sc., Ph.D., MBA 表示。&#34;Norgine 在欧洲、澳大利亚和新西兰的专业药物领域的良好记录与我们在临床开发方面的实力和持续的注册努力相辅相成。我们共同的目标是扩大对生活在这种严重疾病中的人们的治疗机会并改善结果。&#34;</p>
<p>tobevibart 和 elebsiran 的组合通过多种机制针对病毒生命周期，提供了治疗该疾病的潜力。Tobevibart 是一种研究中的中和单克隆抗体，旨在增强免疫反应。Elebsiran 是一种研究中的小干扰 RNA（siRNA），旨在实现对肝脏的靶向递送，并减少乙型肝炎表面抗原，这是一种乙型肝炎病毒生命周期所需的蛋白质。</p>
<p><strong>关于 Tobevibart 和 Elebsiran</strong></p>
<p>Tobevibart 是一种研究中的广谱中和单克隆抗体，针对乙型肝炎表面抗原（HBsAg）。它旨在抑制乙型肝炎和肝炎δ病毒进入肝细胞，并减少血液中循环的病毒和亚病毒颗粒的水平。Tobevibart 是通过 Vir Biotechnology 的专有单克隆抗体发现平台识别的。Fc 结构域经过工程设计，以增强免疫反应和 HBsAg 免疫复合物的清除，并结合了 Xencor 的 Xtend™技术以延长半衰期。Tobevibart 通过皮下注射给药，目前正在进行慢性肝炎δ患者的临床开发。</p>
<p>Elebsiran 是一种针对乙型肝炎病毒的小干扰核糖核酸（siRNA），由 Alnylam Pharmaceuticals, Inc.发现。它旨在降解乙型肝炎病毒 RNA 转录物，并限制乙型肝炎表面抗原的产生。目前的数据表明，它可能对乙型肝炎病毒和肝炎δ病毒具有直接的抗病毒活性。Elebsiran 通过皮下注射给药，目前正在进行慢性肝炎δ（CHD）患者的临床开发。</p>
<p>tobevibart 和 elebsiran 的组合已获得美国食品和药物管理局（FDA）的突破性疗法和快速通道认证，以及欧洲药品管理局（EMA）的优先药物（PRIME）和孤儿药认证。</p>
<p><strong>关于慢性肝炎δ（CHD）</strong></p>
<p>CHD 是最严重的慢性病毒性肝炎形式，最近被国际癌症研究机构分类为致癌物。生活在这种疾病中的人们迅速进展为肝硬化、肝衰竭和与肝脏相关的死亡。目前在美国没有批准的治疗方案，欧盟和全球的选择也有限。</p>
<p><strong>关于 Norgine</strong></p>
<p>Norgine 是一家中型的欧洲制药公司，拥有 1500 名员工，年销售额约为 6 亿美元。在 Norgine，创新推动我们的使命，即提供改变生活的药物。从便秘等常见病症到儿童癌症等罕见和严重疾病，我们针对未满足的医疗需求，因为我们相信每一个科学突破都应当惠及需要帮助的患者。</p>
<p>我们利用创新的开发、商业化和制造能力，以及战略合作伙伴关系来应对复杂的路径。结合我们丰富的历史和深厚的区域专业知识，这种方法使我们能够加速并扩大改变生命的药物在欧洲、澳大利亚和新西兰的覆盖范围。</p>
<p>我们受到医疗专业人士和患者对我们的信任的指引，始终致力于提供能够改变生活的创新，一次一个患者。</p>
<p><strong>参考文献：</strong></p>
<p>1 NIH 国家糖尿病和消化及肾脏疾病研究所 乙型肝炎 D - NIDDK (nih.gov)，访问时间：2025 年 9 月</p>
<p>2 Karagas, Margaret R 等，<em>乙型肝炎 D 病毒、人类巨细胞病毒和梅克尔细胞多瘤病毒的致癌性，</em>《柳叶刀肿瘤学》，第 26 卷，第 8 期，994 – 995。</p>
<p>3 CDC 乙型肝炎 D 是什么 - 常见问题 | CDC，访问时间：2025 年 9 月</p>
<p><strong>前瞻性声明</strong></p>
<p>本新闻稿包含前瞻性声明，包括关于我们未来运营、战略、计划、目标和预期产品发布的声明。前瞻性声明基于当前的期望和假设，并涉及已知和未知的风险和不确定性，这些因素可能导致实际结果与所表达或暗示的结果存在重大差异。诸如 “预期”、“相信”、“期望”、“打算”、“可能”、“计划”、“寻求” 等词语标识此类声明。</p>
<p>可能导致实际结果不同的因素包括但不限于：监管批准、临床开发结果、制造和供应链风险、市场接受度、竞争动态以及适用法律的变化。前瞻性声明仅在本发布之日有效。诺尔金不承担更新或修订任何前瞻性声明的义务，除非法律要求。</p>
<p>Logo - https://mma.prnewswire.com/media/2846726/5684424/Norgine_Logo.jpg</p>
<p>来源 诺尔金制药有限公司</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjUxMjE3Jk5ld3NJdGVtSWQ9TE40ODYzNiZUcmFuc21pc3Npb25fSWQ9MjAyNTEyMTcwMzAxUFJfTkVXU19VU1BSX19fX19MTjQ4NjM2?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://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjUxMjE3Jk5ld3NJdGVtSWQ9TE40ODYzNiZUcmFuc21pc3Npb25fSWQ9MjAyNTEyMTcwMzAxUFJfTkVXU19VU1BSX19fX19MTjQ4NjM2"/></p>

<p>Norgine 与 Vir Biotechnology 达成独家许可协议，在欧洲、澳大利亚和新西兰商业化慢性肝炎δ治疗。Vir 将获得 5500 万欧元的初始付款，以及高达 4.95 亿欧元的里程碑付款。Norgine 将负责商业化和市场授权，而临床开发费用将由双方共同承担。该协议旨在满足对慢性肝炎δ治疗的未满足医疗需求</p>

<ul>
<li><em>Agreement underscores Norgine's mission to bring innovative therapies to patients and builds on our heritage in hepatology and specialty pharmaceuticals.</em></li>
<li><em>Vir Biotechnology's chronic hepatitis delta treatment candidate has shown robust virological responses and reflects a differentiated approach to treatment.</em></li>
</ul>
<div class="lb-trans"><ul>
<li><em>协议强调了 Norgine 的使命，即为患者带来创新疗法，并基于我们在肝病学和专业药品领域的传统。</em></li>
<li><em>Vir Biotechnology 的慢性肝炎δ治疗候选药物显示出强劲的病毒学反应，反映出一种差异化的治疗方法。</em></li>
</ul>
</div><p>, /PRNewswire/ -- Norgine, a leading European specialty pharmaceutical company, today announced an exclusive licensing agreement under which Norgine will commercialise the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta (CHD) in Europe, Australia and New Zealand following the necessary marketing authorisations. There is a high unmet medical need for effective treatments for CHD given potential limitations with existing treatment options.</p>
<div class="lb-trans"><p>, /PRNewswire/ -- Norgine，一家领先的欧洲专业制药公司，今天宣布了一项独家许可协议，根据该协议，Norgine 将在获得必要的市场授权后，在欧洲、澳大利亚和新西兰商业化 tobevibart 和 elebsiran 的组合用于治疗慢性肝炎δ（CHD）。由于现有治疗选择的潜在局限性，CHD 对有效治疗的需求非常迫切。</p>
</div><p>Under the terms of the licensing agreement, Vir Biotechnology will receive a EUR 55 million initial reimbursement payment and up to EUR 495 million in potential regulatory and commercial milestone payments. Additionally, Vir Biotechnology will receive tiered, mid-teen to high-twenties percent royalties on net sales in Norgine's licensed territories. Clinical development costs for the ongoing trials in Vir Biotechnology's ECLIPSE registrational program (ECLIPSE 1, 2 and 3) will be shared, with Norgine contributing a percentage of go-forward external costs. Norgine will be responsible for all commercialisation activities and will hold all marketing authorisations in its licensed territories. The closing of this transaction with respect to certain jurisdictions outside the United States is subject to Norgine receiving regulatory approval from the applicable authorities as may be required.</p>
<div class="lb-trans"><p>根据许可协议的条款，Vir Biotechnology 将获得 5500 万欧元的初始补偿款，以及最多 4.95 亿欧元的潜在监管和商业里程碑付款。此外，Vir Biotechnology 将在 Norgine 的许可区域内获得净销售额的中等青少年到高二十几的百分比的分级版税。Vir Biotechnology 在其 ECLIPSE 注册项目（ECLIPSE 1、2 和 3）中进行的临床开发费用将由双方分担，Norgine 将承担一定比例的后续外部费用。Norgine 将负责所有商业化活动，并将在其许可区域内持有所有市场授权。该交易在美国以外某些司法管辖区的完成取决于 Norgine 获得相关当局的监管批准。</p>
</div><p>&#34;Norgine has a rich history in hepatology and specialty care and this transaction represents a highly innovative and synergistic portfolio addition to continue our strong foothold in this space,&#34; said Janneke van der Kamp, Chief Executive Officer of Norgine. &#34;By combining our proven commercial and regional expertise with cutting-edge science from Vir Biotechnology, we are reinforcing our commitment to improving healthcare outcomes. Collaborations like this affirm Norgine's position as a partner-of-choice for companies seeking a trusted collaborator in Europe, Australia and New Zealand.&#34;</p>
<div class="lb-trans"><p>&#34;Norgine 在肝病学和专业护理方面有着丰富的历史，这笔交易代表了一个高度创新和协同的产品组合，继续巩固我们在这一领域的强大立足点，&#34; Norgine 首席执行官 Janneke van der Kamp 表示。&#34;通过将我们经过验证的商业和区域专业知识与 Vir Biotechnology 的前沿科学相结合，我们正在加强我们改善医疗保健结果的承诺。像这样的合作关系确认了 Norgine 作为寻求在欧洲、澳大利亚和新西兰找到可信赖合作伙伴的公司的首选合作伙伴的地位。&#34;</p>
</div><p>&#34;This collaboration strengthens our ability to deliver this important therapy to patients with chronic hepatitis delta in need of efficacious, safe and convenient treatment options,&#34; said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. &#34;Norgine's proven track record in specialty medicines across Europe, Australia and New Zealand complements our clinical development mettle and ongoing registrational efforts. Together, we aim to broaden access and improve outcomes for people living with this severe disease.&#34;</p>
<div class="lb-trans"><p>&#34;这项合作增强了我们为需要有效、安全和便捷治疗选择的慢性肝炎δ患者提供这一重要疗法的能力，&#34; Vir Biotechnology 首席执行官 Marianne De Backer，M.Sc., Ph.D., MBA 表示。&#34;Norgine 在欧洲、澳大利亚和新西兰的专业药物领域的良好记录与我们在临床开发方面的实力和持续的注册努力相辅相成。我们共同的目标是扩大对生活在这种严重疾病中的人们的治疗机会并改善结果。&#34;</p>
</div><p>The combination of tobevibart and elebsiran offers the potential to treat the disease by tackling the viral lifecycle through multiple mechanisms. Tobevibart is an investigational neutralising monoclonal antibody that has been engineered for immune engagement. Elebsiran is an investigational small interfering RNA (siRNA) that is designed to enable targeted delivery to the liver and to reduce hepatitis B surface antigen, a protein which is required for the hepatitis D virus life cycle.</p>
<div class="lb-trans"><p>tobevibart 和 elebsiran 的组合通过多种机制针对病毒生命周期，提供了治疗该疾病的潜力。Tobevibart 是一种研究中的中和单克隆抗体，旨在增强免疫反应。Elebsiran 是一种研究中的小干扰 RNA（siRNA），旨在实现对肝脏的靶向递送，并减少乙型肝炎表面抗原，这是一种乙型肝炎病毒生命周期所需的蛋白质。</p>
</div><p><strong>About Tobevibart and Elebsiran</strong></p>
<div class="lb-trans"><p><strong>关于 Tobevibart 和 Elebsiran</strong></p>
</div><p>Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen (HBsAg). It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology's proprietary monoclonal antibody discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor's Xtend™ technology to extend half-life. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta.</p>
<div class="lb-trans"><p>Tobevibart 是一种研究中的广谱中和单克隆抗体，针对乙型肝炎表面抗原（HBsAg）。它旨在抑制乙型肝炎和肝炎δ病毒进入肝细胞，并减少血液中循环的病毒和亚病毒颗粒的水平。Tobevibart 是通过 Vir Biotechnology 的专有单克隆抗体发现平台识别的。Fc 结构域经过工程设计，以增强免疫反应和 HBsAg 免疫复合物的清除，并结合了 Xencor 的 Xtend™技术以延长半衰期。Tobevibart 通过皮下注射给药，目前正在进行慢性肝炎δ患者的临床开发。</p>
</div><p>Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) discovered by Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicate that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta (CHD).</p>
<div class="lb-trans"><p>Elebsiran 是一种针对乙型肝炎病毒的小干扰核糖核酸（siRNA），由 Alnylam Pharmaceuticals, Inc.发现。它旨在降解乙型肝炎病毒 RNA 转录物，并限制乙型肝炎表面抗原的产生。目前的数据表明，它可能对乙型肝炎病毒和肝炎δ病毒具有直接的抗病毒活性。Elebsiran 通过皮下注射给药，目前正在进行慢性肝炎δ（CHD）患者的临床开发。</p>
</div><p>The combination of tobevibart and elebsiran has been granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA), and Priority Medicines (PRIME) and orphan drug designations by the European Medicines Agency (EMA).</p>
<div class="lb-trans"><p>tobevibart 和 elebsiran 的组合已获得美国食品和药物管理局（FDA）的突破性疗法和快速通道认证，以及欧洲药品管理局（EMA）的优先药物（PRIME）和孤儿药认证。</p>
</div><p><strong>About Chronic Hepatitis Delta (CHD)</strong></p>
<div class="lb-trans"><p><strong>关于慢性肝炎δ（CHD）</strong></p>
</div><p>CHD is the most severe form of chronic viral hepatitis1 and was recently classified as carcinogenic by the International Agency for Research on Cancer.2 People living with the disease rapidly progress to cirrhosis, liver failure3 and liver-related death.1 There are currently no approved treatments in the U.S., and options are limited in the European Union and globally.</p>
<div class="lb-trans"><p>CHD 是最严重的慢性病毒性肝炎形式，最近被国际癌症研究机构分类为致癌物。生活在这种疾病中的人们迅速进展为肝硬化、肝衰竭和与肝脏相关的死亡。目前在美国没有批准的治疗方案，欧盟和全球的选择也有限。</p>
</div><p><strong>About Norgine</strong></p>
<div class="lb-trans"><p><strong>关于 Norgine</strong></p>
</div><p>Norgine is a mid-sized EU-based pharmaceutical company with 1,500 employees, generating approximately $600 million in annual sales. At Norgine, innovation drives our mission to deliver medicines that change lives. From common conditions like constipation to rare and severe diseases such as childhood cancer, we target unmet medical needs because we believe that every scientific breakthrough deserves to reach patients in need.</p>
<div class="lb-trans"><p>Norgine 是一家中型的欧洲制药公司，拥有 1500 名员工，年销售额约为 6 亿美元。在 Norgine，创新推动我们的使命，即提供改变生活的药物。从便秘等常见病症到儿童癌症等罕见和严重疾病，我们针对未满足的医疗需求，因为我们相信每一个科学突破都应当惠及需要帮助的患者。</p>
</div><p>We use our innovative development, commercialisation and manufacturing capabilities as well as strategic partnerships to navigate complex pathways. Combined with our extensive history and deep regional expertise, this approach allows us to accelerate and expand the reach of life-changing medicines across Europe, Australia, and New Zealand.</p>
<div class="lb-trans"><p>我们利用创新的开发、商业化和制造能力，以及战略合作伙伴关系来应对复杂的路径。结合我们丰富的历史和深厚的区域专业知识，这种方法使我们能够加速并扩大改变生命的药物在欧洲、澳大利亚和新西兰的覆盖范围。</p>
</div><p>We are guided by the trust that healthcare professionals and patients place in us and remain committed to delivering innovation that transforms lives, one patient at a time.</p>
<div class="lb-trans"><p>我们受到医疗专业人士和患者对我们的信任的指引，始终致力于提供能够改变生活的创新，一次一个患者。</p>
</div><p><strong>References:</strong></p>
<div class="lb-trans"><p><strong>参考文献：</strong></p>
</div><p>1 NIH National Institute of Diabetes and Digestive and Kidney Diseases Hepatitis D - NIDDK (nih.gov), accessed September 2025</p>
<div class="lb-trans"><p>1 NIH 国家糖尿病和消化及肾脏疾病研究所 乙型肝炎 D - NIDDK (nih.gov)，访问时间：2025 年 9 月</p>
</div><p>2 Karagas, Margaret R et al., <em>Carcinogenicity of hepatitis D virus, human cytomegalovirus, and Merkel cell polyomavirus,</em> The Lancet Oncology, Volume 26, Issue 8, 994 – 995.</p>
<div class="lb-trans"><p>2 Karagas, Margaret R 等，<em>乙型肝炎 D 病毒、人类巨细胞病毒和梅克尔细胞多瘤病毒的致癌性，</em>《柳叶刀肿瘤学》，第 26 卷，第 8 期，994 – 995。</p>
</div><p>3 CDC What is Hepatitis D - FAQ | CDC, accessed September 2025</p>
<div class="lb-trans"><p>3 CDC 乙型肝炎 D 是什么 - 常见问题 | CDC，访问时间：2025 年 9 月</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性声明</strong></p>
</div><p>This press release contains forward-looking statements, including statements regarding our future operations, strategy, plans, objectives, and anticipated product launches. Forward-looking statements are based on current expectations and assumptions and involve known and unknown risks and uncertainties that may cause actual results to differ materially from those expressed or implied. Words such as &#34;anticipate&#34;, &#34;believe&#34;, &#34;expect&#34;, &#34;intend&#34;, &#34;may&#34;, &#34;plan&#34;, &#34;seek&#34;, and similar expressions identify such statements.</p>
<div class="lb-trans"><p>本新闻稿包含前瞻性声明，包括关于我们未来运营、战略、计划、目标和预期产品发布的声明。前瞻性声明基于当前的期望和假设，并涉及已知和未知的风险和不确定性，这些因素可能导致实际结果与所表达或暗示的结果存在重大差异。诸如 “预期”、“相信”、“期望”、“打算”、“可能”、“计划”、“寻求” 等词语标识此类声明。</p>
</div><p>Factors that could cause actual results to differ include, among others: regulatory approvals, clinical development outcomes, manufacturing and supply chain risks, market acceptance, competitive dynamics, and changes in applicable laws. Forward-looking statements speak only as of the date of this release. Norgine undertakes no obligation to update or revise any forward-looking statements, except as required by law.</p>
<div class="lb-trans"><p>可能导致实际结果不同的因素包括但不限于：监管批准、临床开发结果、制造和供应链风险、市场接受度、竞争动态以及适用法律的变化。前瞻性声明仅在本发布之日有效。诺尔金不承担更新或修订任何前瞻性声明的义务，除非法律要求。</p>
</div><p>Logo - https://mma.prnewswire.com/media/2846726/5684424/Norgine_Logo.jpg</p>
<div class="lb-trans"><p>Logo - https://mma.prnewswire.com/media/2846726/5684424/Norgine_Logo.jpg</p>
</div><p>SOURCE Norgine Pharmaceuticals Limited</p>
<div class="lb-trans"><p>来源 诺尔金制药有限公司</p>
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Norgine 通过与 Vir Biotechnology 达成独家授权协议，增强了其肝病学和专业产品组合