Elebsiran

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

Cohort 4 follow-up confirms durable hepatitis B surface antigen (HBsAg) loss at 24 weeks post end of treatment (EOT) in BRII-179 anti-HBs responders treated with elebsiran plus pegylated interferon alfa (PEG-IFNα) Data suggest the potential to shorten PEG-IFNα treatment duration for BRII-179 anti-HBs responders showing faster and greater HBsAg reduction DURHAM, N.C. and BEIJING, Nov. 10, 2025 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio," or the "Company", stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet medical needs, announced 24-week post end of treatment (EOT) follow-up results from Cohort 4 of its ongoing Phase 2 ENSURE study. These late-breaking data were presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting®, held in Washington D.C. from November 7-11, 2025, and were simultaneously published in Nature Medicine (link). ENSURE (NCT05970289) is a multicenter, open-label Phase 2 study in the Asia-Pacific region. Cohort 4 evaluates a novel sequential combination treatment strategy for hepatitis B virus (HBV), utilizing Brii Bio's therapeutic vaccine, BRII-179, to prime and enrich patients, with a goal to improve responsiveness to therapies potentially offering a functional cure. Participants previously treated with nine doses of elebsiran and BRII-179 treatment in a prior Phase 2 study BRII-179-835-001 (NCT04749368) were enrolled to this cohort to receive 48 weeks of combination treatment with elebsiran and PEG-IFNα. These participants were categorized as BRII-179 anti-HBs responders or non-responders based on their peak hepatitis B surface antibody (anti-HBs) levels during the prior study (≥10 IU/L or <10 IU/L, respectively). EOT data from Cohort 4 were previously presented at the European Association for the Study of the Liver (EASL) Congress 2025. The newly reported data confirm that the HBsAg loss benefit in the BRII-179 responder group was sustained over time. At EOT, 58% (11/19) HBsAg loss was observed in BRII-179 anti-HBs responders. In anti-HBs non-responders, only 17% (2/12) achieved HBsAg loss. At 24 weeks post EOT, 42% (8/19) of anti-HBs responders maintained HBsAg loss compared to 8% (1/12) of anti-HBs non-responders. 50% (4/8) of anti-HBs responders with sustained HBsAg loss at 24 weeks post EOT had baseline HBsAg levels between 1,514-3,086 IU/mL when enrolled in the previous BRII-179-835-001 study suggesting BRII-179 may elicit anti-HBs responses even in patients with higher baseline surface antigen levels. This supports BRII-179's potential to improve functional cure outcomes and broaden its applicability across diverse patient populations. To further define BRII-179's role in treatment of HBV infection and optimize combination regimens for pivotal studies, Brii Bio is conducting two additional Phase 2b trials. The ENRICH study evaluates the role of BRII-179 in priming HBV-specific immunity and/or identifying immuno-responsive patients with a higher likelihood of achieving functional cure. The ENHANCE study includes two parts: one to evaluate the triple combination of BRII-179, elebsiran and PEG-IFNα given concurrently for 48 weeks, and another exploring a sequential approach of BRII-179 and elebsiran for 24 weeks followed by triple combination for 24 weeks, and a 48-week PEG-IFNα control arm. Both studies are fully enrolled, and EOT data are expected to be presented in 2026. "We are encouraged to see that the difference in HBsAg seroclearance rates observed at EOT was maintained through 24 weeks of follow-up." said David Margolis, MD, Chief Medical Officer of Brii Bio. "These results support BRII-179's potential to deliver more rapid and durable HBsAg loss and potentially enable a shorter treatment duration of PEG-IFNα. We look forward to validating these findings in our ongoing confirmatory studies." Publication Number: 5036 Title: Chronic hepatitis B virus infected participants responding to prior BRII-179 treatment achieved higher rate of sustained hepatitis B virus surface antigen loss on elebsiran plus pegylated interferon alfa: follow-up data from ENSURE study Presenter: Grace Lai-Hung Wong, MBChB (CUHK), MD (CUHK), FRCP (Lond, Edin), FHKCP, FHKAM (Medicine), Professor of Gastroenterology and Hepatology at CUHK Medical Data Analytics Centre (MDAC) and Department of Medicine and Therapeutics in Hong Kong SAR, China A total of 31 participants were analyzed, with 19 BRII-179-induced anti-HBs responders and 12 non-responders. Median [range] HBsAg at baseline of this ENSURE study was numerically higher in anti-HBs responders (520 [34-2165] IU/mL) than in non-responders (185 [51-672] IU/mL). At 24 weeks post EOT, a notably higher rate of HBsAg loss was achieved in BRII-179-induced anti-HBs responders (8/19, 42.1%) compared to non-responders (1/12, 8.3%). Although all participants with sustained HBsAg loss had HBsAg < 1,500 IU/mL at baseline of this ENSURE study, 4/8 (50.0%) from anti-HBs responders had baseline HBsAg ranging from 1,514-3,086 IU/mL when enrolled in the previous study, suggesting that BRII-179 may induce anti-HBs responses regardless of baseline HBsAg level. The elebsiran and PEG-IFNα combination was generally safe and well-tolerated. About Hepatitis B Hepatitis B virus (HBV) infection is one of the world's most significant infectious disease threats with more than 254 million people infected globally.[1] Chronic HBV infection is the leading cause of liver disease and an estimated 820,000 people die of complications from chronic HBV infection each year.[1] HBV is of exceptional concern in China, where 87 million people are chronically infected.[2] About BRII-179 BRII-179 is a novel recombinant protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, and is designed to induce enhanced and broad B-cell and T-cell immunity. In November 2023, the Center for Drug Evaluation (the "CDE") of the National Medical Products Administration (the "NMPA") granted BRII-179 Breakthrough Therapy Designation. About Elebsiran Elebsiran is an investigational subcutaneously administered HBV-targeting siRNA designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. It has the potential to have direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. Brii Bio licensed exclusive rights to develop and commercialize elebsiran for the Greater China territory from Vir Biotechnology, Inc. in 2020. In May 2024, the CDE of the NMPA granted elebsiran Breakthrough Therapy Designation. About Brii Bio Brii Biosciences Limited ("Brii Bio", stock code: 2137.HK) is a biotechnology company developing therapies to address major public health challenges where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B virus (HBV) infection. The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, visit . SOURCE Brii Biosciences Limited 21% more press release views with Request a Demo