Tobevibart

Agreement underscores Norgine's mission to bring innovative therapies to patients and builds on our heritage in hepatology and specialty pharmaceuticals. Vir Biotechnology's chronic hepatitis delta treatment candidate has shown robust virological responses and reflects a differentiated approach to treatment. UXBRIDGE, England, Dec. 17, 2025 /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. 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. "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," said Janneke van der Kamp, Chief Executive Officer of Norgine. "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." "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," said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. "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." 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. About Tobevibart and Elebsiran 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. 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). 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). About Chronic Hepatitis Delta (CHD) 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. About Norgine 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. 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. 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. References: 1 NIH National Institute of Diabetes and Digestive and Kidney Diseases Hepatitis D - NIDDK (nih.gov), accessed September 2025 2 Karagas, Margaret R et al., Carcinogenicity of hepatitis D virus, human cytomegalovirus, and Merkel cell polyomavirus, The Lancet Oncology, Volume 26, Issue 8, 994 – 995. 3 CDC What is Hepatitis D - FAQ | CDC, accessed September 2025 Forward-Looking Statements 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 "anticipate", "believe", "expect", "intend", "may", "plan", "seek", and similar expressions identify such statements. 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. Logo - SOURCE Norgine Pharmaceuticals Limited 21% more press release views with Request a Demo

▎Armstrong 2025年12月16日，Vir Bio宣布将丁肝联合疗法欧洲、澳大利亚、新西兰的权益授权给Norgine，后者支付5500万欧元预付款，4.95亿欧元里程碑金额，以及中双位数至20%百分比的销售分成。 Vir Bio聚焦肝病和肿瘤疗法，丁肝联合疗法Tobevibart+elebsiran目前处于注册临床阶段（ECLIPSE 1,2,3）. 全球范围内有700万例丁肝患者，仍然存在严重的未满足临床需求。 Tobevibart为一款HBsAg抗体，elebsiran为一款降解乙肝RNA的siRNA。 今年AASLD会议上，Vir Bio披露了该联合疗法的二期临床数据，联合治疗24周时病毒响应率为41%，48周时病毒响应率为66%。 总结 丁肝领域，越来越受到行业关注，前不久Mirum以8.2亿美元收购Bluejay获得其丁肝中和抗体。此次，Vir Bio将丁肝联合疗法的欧洲等权益以5.5亿欧元授权给Norgine。国内方面，华辉安健HH-003为全球首创的PreS1抗体，目前处于上市审评阶段，此前已经获得中国、美国双重突破疗法认定。今年AASLD会议上，华辉安健披露了2b期关键注册性临床数据，HH-003在复合终点应答率、病毒学抑制、ALT复常及肝脏硬度改善方面均显示优异疗效。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理； 补体靶向药物技术全梳理； 补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理； 靶点冷暖，行业自知； 中国大分子新药研发格局； 被炮轰的“me too”； 佐剂百年史； 胰岛素百年传奇； CUSBEA：风雨四十载； 中国新药研发的焦虑； 中国生物医药企业的研发竞争； 中国双抗竞争格局； 中国ADC竞争格局； 中国双抗技术全梳理； 中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理； 亘喜生物技术全梳理； 康哲药业技术全梳理； 科济药业技术全梳理； 恺佧生物技术全梳理； 同宜医药技术全梳理； 百奥赛图技术全梳理； 腾盛博药技术全梳理； 创胜集团技术全梳理； 永泰生物技术全梳理； 中国抗体技术全梳理； 德琪医药技术全梳理； 德琪医药技术全梳理2.0； 和铂医药技术全梳理； 荣昌生物技术全梳理； 再鼎医药技术全梳理； 药明生物技术全梳理； 恒瑞医药技术全梳理； 豪森药业技术全梳理； 正大天晴技术全梳理； 吉凯基因技术全梳理； 基石药业技术全梳理； 百济神州技术全梳理； 百济神州技术全梳理第2版； 信达生物技术全梳理； 信达生物技术全梳理第2版； 中山康方技术全梳理； 复宏汉霖技术全梳理； 先声药业技术全梳理； 君实生物技术全梳理； 嘉和生物技术全梳理； 志道生物技术全梳理； 道尔生物技术全梳理； 尚健生物技术全梳理； 康宁杰瑞技术全梳理； 科望医药技术全梳理； 岸迈生物技术全梳理； 礼进生物技术全梳理； 康桥资本技术全梳理； 余国良的抗体药布局； 荃信生物技术全梳理； 安源医药技术全梳理； 三生国健技术全梳理； 仁会生物技术全梳理； 乐普生物技术全梳理； 同润生物技术全梳理； 宜明昂科技术全梳理； 派格生物技术全梳理； 迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理； 普米斯生物技术全梳理； 普米斯生物技术全梳理2.0； 三叶草生物技术全梳理； 贝达药业抗体药全梳理； 泽璟制药抗体药全梳理； 恒瑞医药抗体药全梳理； 齐鲁制药抗体药全梳理； 石药集团抗体药全梳理； 豪森药业抗体药全梳理； 华海药业抗体药全梳理； 科伦药业抗体药全梳理； 百奥泰技术全梳理； 凡恩世技术全梳理。