An Open-label, Phase 2 Trial to Evaluate the Efficacy and Safety of a Single Intravenous Administration of GNT0003 (an Adeno-associated Viral (AAV) Vector Expressing the UGT1A1 Transgene) Following Imlifidase Pre-treatment in Adult Participants With Severe Crigler-Najjar Syndrome (CNS) Requiring Daily Phototherapy and Presenting Pre-existing Anti-AAV8 Antibodies

Clinical trial rationale:
CNS is an ultra-rare (<1/1 million newborns), autosomal recessive disorder of bilirubin conjugation caused by mutation in the gene coding for uridine 5'-diphosphate glucuronosyltransferase (UGT1A1), that causes the accumulation of neurotoxic unconjugated bilirubin (UCB).
Reduction of UCB is managed with phenobarbital in mild CNS, and daily phototherapy in severe CNS.
There is no authorized curative medical treatment for CNS. Liver transplantation is currently the only curative treatment for severe CNS.
GNT0003 is a genetically modified recombinant (r) viral vector composed of the AAV8 viral capsid carrying the UGT1A1 transgene which aims to correct the dysfunction of the mutated gene by achieving durable expression of a functional copy of the affected gene.
Imlifidase (IgG-degrading enzyme) has demonstrated its efficacy in highly sensitized adult kidney transplant patients.
To give participants with pre-existing anti-AAV8 antibodies access to gene therapy treatments, this trial aims to demonstrate the safety and efficacy of GNT0003 following imlifidase pre-treatment in adult participants with severe CNS requiring daily phototherapy and presenting with pre-existing anti-AAV8 antibodies.
Primary objective: to assess efficacy of a single intravenous administration of GNT0003 following imlifidase pre-treatment in participants with severe CNS requiring phototherapy and pre-existing AAV8 antibodies
Secondary objective: to collect data on safety and tolerability of GNT0003 and imlifidase, efficacy of imlifidase, pharmacokinetic and pharmacodynamic profile of GNT0003, and Quality of Life.
The trial will include 3 parts:
* A baseline period for at least 3 months
* A treatment period
* A follow-up period:
* Initial post-treatment follow-up over 48 weeks
* Long-term follow-up for 4 additional years
This trial will be conducted in accordance with the International Conference on Harmonization Guideline for Good Clinical Practice and the Declaration of Helsinki. Participants must be consented using the approved Informed Consent Form before any procedures specified in the protocol are performed.

开始日期2024-11-08

申办/合作机构

Genethon

[+1]

NCT06461546

/ Withdrawn临床2期IIT

Imlifidase in Living Donor Renal Transplantation Highly Sensitized Recipients (LIVEDES)

This is a Phase II, pilot, prospective, unicentric trial, to evaluate Imlifidase could improve the transplantability of the highly sensitized patients with good outcomes respect to survival and functionality of the graft.

开始日期2024-10-22

申办/合作机构-

100 项与 Imlifidase 相关的临床结果

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100 项与 Imlifidase 相关的转化医学

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100 项与 Imlifidase 相关的专利（医药）

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112

项与 Imlifidase 相关的文献（医药）

2026-04-01·Current Opinion in Organ Transplantation

Managing the highly sensitized kidney transplant patient

Review

作者: Jackson, Kyle R. ; Parsons, Ronald F.

Purpose of review:

Highly sensitized kidney transplant candidates, particularly those with calculated panel reactive antibody (CPRA) ≥99.9%, face significant immunologic barriers to transplantation. This review highlights recent clinical strategies that have improved transplant access and outcomes in this population, with a focus on allocation policy, kidney-paired donation, and desensitization.

Recent findings:

Updates from national allocation systems and kidney-paired donation programs have demonstrated substantial gains in transplant access for many highly sensitized candidates. However, those with CPRA at least 99.9% remain difficult to match. Novel desensitization approaches, such as imlifidase, proteasome inhibitors, anti-CD38 mAbs, and early-phase CAR T-cell therapies have shown promise in selected patients. Increasingly, immunologic phenotyping or gene expression profiling may help tailor desensitization strategies to individual recipients.

Summary:

Most highly sensitized candidates now achieve transplant through allocation policy or paired donation. For those with CPRA at least 99.9%, desensitization will likely remain an important tool to facilitate transplantation. Emerging therapies and immunologic profiling may help individualize treatment and expand transplant access for this challenging group.

2026-03-31·PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Polypharmacology of S-1117, an Fc-fused IgG-selective degrading enzyme, for chronic treatment of autoantibody-mediated diseases

Article

作者: Le, Nam ; Mascanfroni, Ivan D. ; Pellerin, Alex ; Vital, Heather ; Green, Tobias ; Sanmarco, Liliana M. ; Sundy, John S. ; Chen, Jiyun ; Newton, Andita ; Otipoby, Kevin L. ; Higginson-Scott, Nathan ; Manasson, Julia ; Peckner, Ryan ; Ramello, Maria Cecilia ; Anderson, Jordan M. ; Xing, Yi ; Plasencia, Agustin

Antigen-specific immunoglobulin-G (IgG) antibodies cause or contribute to the pathogenesis of a wide spectrum of human diseases and conditions. Multiple therapeutic approaches have been developed, yet they are limited by variable safety and efficacy, patient inconvenience, and cost. IdeS, a cysteine protease derived from S. pyogenes , specifically cleaves IgG antibodies, representing a unique opportunity for the treatment of IgG-mediated diseases. However, clinical utilization of IdeS is limited by the immunogenic nature of bacterial proteases and short half-life. Using Seismic’s IMPACT platform, we engineered S-1117, an IgG cleaving enzyme fused to a human effectorless IgG1 Fc domain for an extended half-life. S-1117 is being developed to address the limitations of existing therapies in IgG-mediated diseases. In vitro and in vivo pharmacology studies demonstrate that S-1117 exhibits reduced B and T cell immunogenicity, a superior pharmacokinetic profile, and manufacturability and developability properties resembling those of monoclonal antibodies. S-1117 cleavage of IgG reduces circulating levels of IgG, including pathogenic IgG autoantibodies and IgG immune-complexes, and reduces IgG antibody effector functions, such as complement fixation, antibody-dependent cellular cytotoxicity, and antibody-dependent cell phagocytosis. The polypharmacology of S-1117 further extends to cleaving the antigen receptor on IgG-positive memory B cells, thereby modulating activation of memory B cells.

2026-01-02·Clinical Kidney Journal

Complement activation in anti-glomerular basement membrane disease before and after treatment with imlifidase

Article

作者: Hellmark, Thomas ; Sonesson, Elisabeth ; Segelmark, Mårten ; Blom, Anna M ; Tyrberg, Linnéa ; Uhlin, Fredrik ; Alam, Shanavaz

ABSTRACT:

Background:

The involvement of the complement system in anti-glomerular basement membrane (GBM) disease is well known but incompletely characterized. The ability of autoantibodies to trigger the classical pathway is evident, while the lectin and alternative pathways also seem to be of importance. We studied complement activation in patients treated with imlifidase, which leads to rapid IgG depletion, to elucidate the role of complement in anti-GBM disease.

Methods:

The GOOD-IDES-01 trial included 15 anti-GBM disease patients treated with one dose of imlifidase in addition to standard therapy with 6 months of follow-up. Plasma samples were analyzed for C3, C4 and complement activation products [C4d, C3bBbP and soluble terminal complement complexes (sTCC)]. Ratios of C4d/C4 and C3bBbP/C3 were calculated to correct for plasmapheresis. Serum samples were analyzed for anti-drug antibodies (ADA) directed against imlifidase.

Results:

The C4d/C4 ratio decreased rapidly from its pre-dose level, while sTCC decreased more slowly. sTCC and C3bBbP/C3 were above the reference level throughout the trial. We observed a transient increase in C4d/C4 and C3bBbP/C3, but not sTCC, immediately following treatment with imlifidase, which tended to be more pronounced in patients with more pre-existing ADA.

Conclusions:

Classical pathway activation decreased rapidly after autoantibody removal by imlifidase and increased again in most of those that experienced a rebound, but terminal complement activation remained elevated throughout the trial. However, due to the small sample size our results must be interpreted with caution.

113

项与 Imlifidase 相关的新闻（医药）

2026-03-26

·动脉网

汉莎生物制药发布2025年年度及可持续发展报告Hansa Biopharma publishes 2025 Annual and Sustainability Reports

LUND, Sweden 瑞典隆德, ，March 26, 2026 2026年3月26日/PRNewswire/ --Hansa Biopharma AB, 'Hansa' or the 'Company' (NASDAQ STOCKHOLM: HNSA), today published its Annual and Sustainability Reports for 2025. /PRNewswire/ -- Hansa Biopharma AB，简称“Hansa”或“公司”（纳斯达克斯德哥尔摩：HNSA），今天发布了其2025年年度及可持续发展报告。Peter Nicklin, Chair of the Board, Hansa Biopharma, said: ' 汉莎生物制药公司董事会主席彼得·尼克林说：'2025 was a year of transformation for Hansa Biopharma, marked by the appointment of Renée Aguiar 2025年是Hansa Biopharma的转型之年，Renée Aguiar的任命成为标志。- -Lucander as our new CEO with a clear mandate to reshape the company for sustainable growth. Under her leadership, we strengthened our foundations by improving our financial resilience and assembling a substantially new leadership team of proven, high 卢坎德出任我们的新首席执行官，肩负明确的使命，重塑公司以实现可持续增长。在她的领导下，我们通过增强财务韧性并组建了一支实力雄厚、经验丰富的全新领导团队，进一步巩固了我们的基础。- -performing leaders. At the same time, we achieved major scientific progress, including highly positive results from the pivotal U.S. Phase 3 imlifidase trial, supporting our preparations for a potential U.S. launch. Complementing this progress, decisive organizational changes have further sharpened our strategic focus and strengthened our capabilities. 表现突出的领导者。同时，我们取得了重大的科学进展，包括来自美国关键的三期imlifidase试验的高度积极的结果，这支持了我们为可能的美国上市所做的准备。与此进展相辅相成的是，果断的组织变革进一步明确了我们的战略重点并增强了我们的能力。With strong clinical momentum and a more resilient platform for growth, Hansa is well. 汉莎公司具有强大的临床动力和更坚实的增长平台，发展良好。- -positioned to deliver meaningful impact for patients and long 准备好为患者带来有意义的影响和长远的效益- -term value for shareholders 股东的期限价值.' .'Renée Aguiar-Lucander, CEO, Hansa Biopharma, said, ' 汉莎生物制药公司首席执行官雷内·阿吉亚尔-卢坎德表示：'2025 was a year of meaningful progress for Hansa. We advanced our science, significantly improved our financial robustness, and positioned the company for long-term growth. The highly statistically significant ConfIdeS results and our BLA submission of imlifidase, marked major steps toward addressing the urgent unmet needs of highly sensitized kidney transplant patients in one of the largest global transplant markets. 2025年对汉萨而言是取得有意义进展的一年。我们推进了科学研究，显著增强了财务稳健性，并为公司的长期增长奠定了基础。ConfIdeS研究结果具有高度统计学意义，我们提交的imlifidase生物制品许可申请（BLA）标志着在满足全球最大移植市场之一中高致敏肾移植患者的迫切未满足需求方面迈出了重要步伐。In Europe, access to IDEFIRIX continued to grow, reflected by a 46% increase in product revenue. We also progressed our gene therapy programs, took a strategic decision to advance our next generation enzyme HNSA-5487 in autoimmune diseases, and continued to embed sustainability across our strategy. As we look ahead to a potential U.S. 在欧洲，IDEFIRIX的使用持续增长，产品收入增长了46%。我们还推进了基因治疗项目，做出了战略性决策以推动我们在自身免疫疾病方面的下一代酶HNSA-5487的发展，并继续将可持续性融入我们的战略中。展望未来，美国市场潜力巨大。approval and further pipeline developments in 2026, I am proud of the dedication of our employees and partners and confident in our ability to deliver transformative therapies to patients who need them most.'. 2026年的审批和进一步的管道开发，我为我们的员工和合作伙伴的奉献精神感到自豪，并对我们为最需要的患者提供变革性治疗的能力充满信心。'2025 highlights 2025年亮点Pivotal U.S. Phase 3 Success 关键的美国第三阶段成功Hansa reported positive topline results from ConfIdeS, its pivotal U.S. Phase 3 trial of imlifidase. The study met its primary endpoint with strong statistical significance (p<0.0001), demonstrating that imlifidase can enable transplantation for highly sensitized patients who otherwise face years on dialysis with very limited or no access to compatible organs. Hansa 报告了其关键的美国 III 期试验 ConfIdeS 中 imlifidase 的积极顶线结果。该研究达到了主要终点，具有很强的统计学意义（p<0.0001），证明了 imlifidase 可以使高度致敏患者进行移植，否则他们将面临多年透析，并且几乎无法获得相容器官。ConfIdeS is the first large, randomized trial of imlifidase and reinforces the clinical relevance of Hansa's IgG cleaving enzyme platform.. ConfIdeS 是 imlifidase 的首个大型随机试验，进一步证实了 Hansa 的 IgG 切割酶平台的临床相关性。BLA Submission to the FDA 向FDA提交BLABuilding on the ConfIdeS results, Hansa submitted a Biologics License Application (BLA) to the FDA in December 2025, seeking approval under the accelerated pathway, a major milestone toward a potential U.S. launch 基于ConfIdeS的研究结果，汉莎于2025年12月向美国食品药品监督管理局（FDA）提交了生物制品许可申请（BLA），寻求通过加速审批通道获得批准，这是迈向潜在美国市场推出的重要里程碑。. 。European Commercial Momentum 欧洲商业势头Across Europe, IDEFIRIX product revenue grew by 46%, driven by increased adoption, two new national guidelines (Spain and Belgium), and expanded reimbursement, which now covers 24 countries. 在整个欧洲，IDEFIRIX产品的收入增长了46%，这得益于采用率的提高、两个新的国家指南（西班牙和比利时）以及报销范围的扩大，目前覆盖了24个国家。Strengthening Financial Position 增强财务状况Hansa significantly strengthened its financial profile by raising approximately USD 96 million and completing a debt restructuring with NovaQuest. These actions enabled continued investment in regulatory activities, commercial readiness for a potential U.S. launch, and advancement of pipeline programs.. 汉莎通过筹集约9600万美元并完成与NovaQuest的债务重组，大幅增强了其财务状况。这些举措使得公司能够持续投资于监管活动、为潜在的美国市场推出做好商业准备，并推进管道项目的进展。Pipeline Advancement: HNSA-5487 管道进展：HNSA-5487Hansa made the strategic decision to advance its next generation enzyme HNSA-5487 into development for Guillain–Barré syndrome (GBS), with FDA interactions planned for first half of 2026. 汉莎做出战略决策，将其下一代酶HNSA-5487推进到吉兰-巴雷综合征（GBS）的开发中，并计划在2026年上半年与FDA进行互动。Strengthened Leadership to Support Next Phase of Growth 加强领导力以支持下一阶段的增长To drive execution of its strategy, Hansa strengthened its executive leadership team with appointments across key roles, including a new CEO, COO & President U.S., Chief Medical Officer, Chief Legal Officer & Corporate Secretary, Chief Human Resources Officer, and SVP Regulatory Affairs. These additions enhance operational depth and support the company's growth ambitions.. 为了推动其战略的执行，汉莎通过在关键职位上进行任命来加强其行政领导团队，包括新的首席执行官、首席运营官兼美国区总裁、首席医疗官、首席法律官兼公司秘书、首席人力资源官以及监管事务高级副总裁。这些人员的加入增强了公司的运营深度，并支持了公司的增长雄心。This is information that Hansa Biopharma AB (publ) is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 7:00 AM CET on 26 March 2026. 这是Hansa Biopharma AB（publ）根据《证券市场法》必须公开的信息。该信息于2026年3月26日欧洲中部时间早上7:00提交发布。Contacts for more information: 更多信息请联系：Evan Ballantyne,Chief Financial Officer 埃文·巴拉ntyne，首席财务官[emailprotected] 电子邮件地址Kerstin Falck,VP Global Corporate Affairs 克尔斯廷·法尔克，全球企业事务副总裁 [emailprotected] 电子邮件地址Notes to editors 编辑须知About Hansa Biopharma 关于Hansa BiopharmaHansa Biopharma AB is a pioneering commercial-stage biopharmaceutical company developing and commercializing novel immunomodulatory therapies to transform care for patients with acute or complex immune disorders. Hansa's proprietary IgG-cleaving enzyme technology platform addresses serious unmet medical needs in transplantation, gene therapy and autoimmune diseases. Hansa Biopharma AB 是一家处于商业阶段的开创性生物制药公司，致力于开发和商业化新型免疫调节疗法，以改变急性或复杂免疫疾病患者的治疗方式。Hansa 专有的 IgG 切割酶技术平台解决了移植、基因治疗和自身免疫疾病领域中未满足的重大医疗需求。The company's portfolio includes imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients, and HNSA-5487, a next-generation IgG-cleaving molecule that will be developed for Guillain-Barré Syndrome (GBS). 公司产品组合包括 imlifidase，这是一种首创的免疫球蛋白 G (IgG) 抗体切割酶疗法，已被证明可以帮助高度致敏患者进行肾移植，以及 HNSA-5487，这是一种下一代 IgG 切割分子，将用于开发治疗吉兰-巴雷综合征 (GBS)。Hansa Biopharma is based in Lund, Sweden, and has operations in Europe and the U.S. The company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at . 汉莎生物制药公司总部位于瑞典隆德，在欧洲和美国开展业务。该公司在纳斯达克斯德哥尔摩上市，股票代码为HNSA。欲了解更多信息，请访问。www.hansabiopharma.com www.hansabiopharma.comand follow us on 关注我们LinkedIn 领英. 。©2026 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and IDEFIRIX flower logo are trademarks of Hansa Biopharma AB, Lund, Sweden. All rights reserved. ©2026 Hansa Biopharma AB。Hansa Biopharma、灯塔标志、IDEFIRIX 和 IDEFIRIX 花形标志是瑞典隆德的 Hansa Biopharma AB 的商标。保留所有权利。Forward-Looking Statements 前瞻性声明This press releasecontainsforward-looking statements relating to the business of Hansa, including, without limitation, statementsregardingHansa's strategy, commercialization efforts, business plans, regulatory submissions, clinical development plans, revenue and product sales projections or forecasts and focus. 本新闻稿包含与汉莎业务相关的前瞻性陈述，包括但不限于关于汉莎的战略、商业化努力、业务计划、监管提交、临床开发计划、收入和产品销售预测或展望的陈述。The words 'may,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'plan,' 'anticipate,' 'intend,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'continue,' 'target,' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. “可能”、“将”、“可以”、“会”、“应该”、“预期”、“计划”、“预期”、“打算”、“相信”、“估计”、“预测”、“预计”、“潜在”、“继续”、“目标”等词语及类似表达旨在识别前瞻性陈述，尽管并非所有前瞻性陈述都包含这些识别词。Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Hansa's business and operations, the presumed mechanism of action of imlifidase, the safety and efficacy of imlifidase inthe patient population aboveor other potential indications, market acceptance of imlifidase, competitive products, anticipated timelines and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements.Hansa cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. 本新闻稿中的任何前瞻性陈述均基于管理层的当前预期和信念，并受到多种风险、不确定性和重要因素的影响，这些因素可能导致实际事件或结果与本新闻稿中包含的任何前瞻性陈述所表达或暗示的内容存在重大差异，包括但不限于与Hansa的业务和运营、imlifidase的假定作用机制、imlifidase在上述患者群体或其他潜在适应症中的安全性和有效性、imlifidase的市场接受度、竞争产品、预期时间表等相关因素，以及其他可能导致实际结果、表现或成就与这些前瞻性陈述所表达或暗示的未来结果、表现或成就存在重大不同的因素。Hansa提醒您不要过度依赖任何前瞻性陈述，这些陈述仅在其发布之日有效。Hansa disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstanc. 汉莎公司否认有任何义务公开更新或修改任何此类声明，以反映预期或事件、条件或情况的任何变化。This information was brought to you by Cision 此信息由Cision提供给您http://news.cision.com http://news.cision.comhttps://news.cision.com/hansa-biopharma-ab/r/hansa-biopharma-publishes-2025-annual-and-sustainability-reports,c4326814 https://news.cision.com/hansa-biopharma-ab/r/hansa-biopharma发布2025年年度及可持续发展报告,c4326814The following files are available for download: 以下文件可供下载：https://mb.cision.com/Main/1219/4326814/4006377.pdf https://mb.cision.com/Main/1219/4326814/4006377.pdfHansa Biopharma Annual Report 2025 汉莎生物制药2025年年度报告https://mb.cision.com/Main/1219/4326814/4006387.zip https://mb.cision.com/Main/1219/4326814/4006387.zip549300LLEO25ZJJ3NT91-2025-12-31-1-sv.zip 549300LLEO25ZJJ3NT91-2025-12-31-1-sv.ziphttps://mb.cision.com/Public/1219/4326814/b3952aca5ea18de9.pdf https://mb.cision.com/Public/1219/4326814/b3952aca5ea18de9.pdfHansa Biopharma Sustainability Report 2025 汉莎生物制药2025年可持续发展报告21 21% %more press release views with 更多新闻发布视图与 Request a Demo 请求演示

2026-03-26

·PRNewswire

Hansa Biopharma publishes 2025 Annual and Sustainability Reports

LUND, Sweden, March 26, 2026 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" or the "Company" (NASDAQ STOCKHOLM: HNSA), today published its Annual and Sustainability Reports for 2025. Peter Nicklin, Chair of the Board, Hansa Biopharma, said: "2025 was a year of transformation for Hansa Biopharma, marked by the appointment of Renée Aguiar-Lucander as our new CEO with a clear mandate to reshape the company for sustainable growth. Under her leadership, we strengthened our foundations by improving our financial resilience and assembling a substantially new leadership team of proven, high-performing leaders. At the same time, we achieved major scientific progress, including highly positive results from the pivotal U.S. Phase 3 imlifidase trial, supporting our preparations for a potential U.S. launch. Complementing this progress, decisive organizational changes have further sharpened our strategic focus and strengthened our capabilities. With strong clinical momentum and a more resilient platform for growth, Hansa is well-positioned to deliver meaningful impact for patients and long-term value for shareholders." Renée Aguiar-Lucander, CEO, Hansa Biopharma, said, "2025 was a year of meaningful progress for Hansa. We advanced our science, significantly improved our financial robustness, and positioned the company for long-term growth. The highly statistically significant ConfIdeS results and our BLA submission of imlifidase, marked major steps toward addressing the urgent unmet needs of highly sensitized kidney transplant patients in one of the largest global transplant markets. In Europe, access to IDEFIRIX continued to grow, reflected by a 46% increase in product revenue. We also progressed our gene therapy programs, took a strategic decision to advance our next generation enzyme HNSA-5487 in autoimmune diseases, and continued to embed sustainability across our strategy. As we look ahead to a potential U.S. approval and further pipeline developments in 2026, I am proud of the dedication of our employees and partners and confident in our ability to deliver transformative therapies to patients who need them most." 2025 highlights Pivotal U.S. Phase 3 Success Hansa reported positive topline results from ConfIdeS, its pivotal U.S. Phase 3 trial of imlifidase. The study met its primary endpoint with strong statistical significance (p<0.0001), demonstrating that imlifidase can enable transplantation for highly sensitized patients who otherwise face years on dialysis with very limited or no access to compatible organs. ConfIdeS is the first large, randomized trial of imlifidase and reinforces the clinical relevance of Hansa's IgG cleaving enzyme platform. BLA Submission to the FDA Building on the ConfIdeS results, Hansa submitted a Biologics License Application (BLA) to the FDA in December 2025, seeking approval under the accelerated pathway, a major milestone toward a potential U.S. launch . European Commercial Momentum Across Europe, IDEFIRIX product revenue grew by 46%, driven by increased adoption, two new national guidelines (Spain and Belgium), and expanded reimbursement, which now covers 24 countries. Strengthening Financial Position Hansa significantly strengthened its financial profile by raising approximately USD 96 million and completing a debt restructuring with NovaQuest. These actions enabled continued investment in regulatory activities, commercial readiness for a potential U.S. launch, and advancement of pipeline programs. Pipeline Advancement: HNSA-5487 Hansa made the strategic decision to advance its next generation enzyme HNSA-5487 into development for Guillain–Barré syndrome (GBS), with FDA interactions planned for first half of 2026. Strengthened Leadership to Support Next Phase of Growth To drive execution of its strategy, Hansa strengthened its executive leadership team with appointments across key roles, including a new CEO, COO & President U.S., Chief Medical Officer, Chief Legal Officer & Corporate Secretary, Chief Human Resources Officer, and SVP Regulatory Affairs. These additions enhance operational depth and support the company's growth ambitions. This is information that Hansa Biopharma AB (publ) is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 7:00 AM CET on 26 March 2026. Contacts for more information: Evan Ballantyne, Chief Financial Officer [email protected] Kerstin Falck, VP Global Corporate Affairs [email protected] Notes to editors About Hansa Biopharma Hansa Biopharma AB is a pioneering commercial-stage biopharmaceutical company developing and commercializing novel immunomodulatory therapies to transform care for patients with acute or complex immune disorders. Hansa's proprietary IgG-cleaving enzyme technology platform addresses serious unmet medical needs in transplantation, gene therapy and autoimmune diseases. The company's portfolio includes imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients, and HNSA-5487, a next-generation IgG-cleaving molecule that will be developed for Guillain-Barré Syndrome (GBS). Hansa Biopharma is based in Lund, Sweden, and has operations in Europe and the U.S. The company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at and follow us on LinkedIn. ©2026 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and IDEFIRIX flower logo are trademarks of Hansa Biopharma AB, Lund, Sweden. All rights reserved. Forward-Looking Statements This press release contains forward-looking statements relating to the business of Hansa, including, without limitation, statements regarding Hansa's strategy, commercialization efforts, business plans, regulatory submissions, clinical development plans, revenue and product sales projections or forecasts and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Hansa's business and operations, the presumed mechanism of action of imlifidase, the safety and efficacy of imlifidase in the patient population above or other potential indications, market acceptance of imlifidase, competitive products, anticipated timelines and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. Hansa cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Hansa disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Hansa's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. This information was brought to you by Cision The following files are available for download: SOURCE Hansa Biopharma AB 21% more press release views with Request a Demo

临床3期临床结果高管变更基因疗法

2026-03-20

·allsci.com

Hansa Bio raises USD 30m convertible note to fund imlifidase US launch

Sweden-based Hansa Biopharma AB, a commercial-stage biopharmaceutical company developing immunomodulatory therapies for patients with acute or complex immune disorders, announced a USD 30 million convertible note financing with funds managed by Athyrium Capital Management, set to close March 20, 2026. The unsecured convertible senior notes mature in March 2031, carry a fixed interest rate of 3% per year, and include a conversion premium of 25% on the 30-day volume-weighted average share price. The company said the financing extends its cash runway into mid-2027 and is intended to support a US launch of its lead candidate imlifidase, subject to US FDA approval. Hansa filed a Biologics License Application for imlifidase with the US FDA in February 2026. Athyrium Capital Management was the sole investor in the transaction. Laurent Hermouet, partner at Athyrium, said the firm believes imlifidase has the potential to be the first product specifically targeting the unmet need among highly sensitized patients on the kidney transplant wait list. CEO Renée Aguiar-Lucander said the transaction positions the company to execute its US launch plan and ensures resources are in place in a timely manner. Hansa Biopharma’s pipeline is built around a proprietary IgG-cleaving enzyme technology platform. The platform uses endopeptidases that rapidly and specifically cleave immunoglobulin G antibodies, neutralizing pathogenic antibodies without broad immunosuppression. Imlifidase, derived from the Streptococcus pyogenes IgG-degrading enzyme IdeS, is the company’s lead candidate and has been developed to enable kidney transplantation in highly sensitized patients whose pre-existing donor-specific antibodies otherwise preclude transplant. Imlifidase received conditional marketing authorization from the European Commission in 2020 under the brand name Idefirix. The company’s second pipeline asset, HNSA-5487, is a next-generation IgG-cleaving molecule being developed for Guillain-Barré Syndrome. The company has also stated that its platform has applications in gene therapy, where pre-existing anti-AAV antibodies can limit patient eligibility for vector-based treatments. The foundational science underlying the platform originated at Lund University, where Professor Lars Björck and colleagues first characterized the IdeS enzyme. Hansa Biopharma was established as a university spinout in 2007, with intellectual property licensed from Lund University. The company’s headquarters remain in Lund. The company has previously entered into a collaboration with Sarepta Therapeutics to explore the use of imlifidase as an enabling treatment for gene therapy by clearing anti-AAV antibodies prior to vector administration.

上市批准免疫疗法基因疗法

100 项与 Imlifidase 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11470	Imlifidase	L04AA41	DB15258

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
肾移植排斥反应	欧盟	Hansa Biopharma AB	2020-08-25
肾移植排斥反应	冰岛	Hansa Biopharma AB	2020-08-25
肾移植排斥反应	列支敦士登	Hansa Biopharma AB	2020-08-25
肾移植排斥反应	挪威	Hansa Biopharma AB	2020-08-25

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
抗肾小球基膜疾病	临床3期	美国	Hansa Biopharma AB	2022-12-22
抗肾小球基膜疾病	临床3期	奥地利	Hansa Biopharma AB	2022-12-22
抗肾小球基膜疾病	临床3期	比利时	Hansa Biopharma AB	2022-12-22
抗肾小球基膜疾病	临床3期	捷克	Hansa Biopharma AB	2022-12-22
抗肾小球基膜疾病	临床3期	丹麦	Hansa Biopharma AB	2022-12-22
抗肾小球基膜疾病	临床3期	法国	Hansa Biopharma AB	2022-12-22
抗肾小球基膜疾病	临床3期	德国	Hansa Biopharma AB	2022-12-22
抗肾小球基膜疾病	临床3期	爱尔兰	Hansa Biopharma AB	2022-12-22
抗肾小球基膜疾病	临床3期	意大利	Hansa Biopharma AB	2022-12-22
抗肾小球基膜疾病	临床3期	荷兰	Hansa Biopharma AB	2022-12-22

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03611621 (17-HMedIdeS-14, PRNewswire)	临床1/2期	肾移植排斥反应 --	39	Imlifidase	廠衊鏇積鹽繭選鬱廠蓋(願艱鬱鑰構顧選鬱鑰醖) = 夢鹽繭齋膚廠構鹽鹹廠膚鹽願築鹽顧範鹹衊壓 (襯夢遞選範齋衊觸獵願 ) 更多	积极	2025-06-30
NCT03943589 (15-HMedIdeS-09, CTgov)	临床2期	格林-巴利综合征	30	Imlifidase	艱憲鹹齋艱鏇顧獵鹹壓(製積構醖遞觸襯顧窪糧) = 鏇蓋齋衊築觸糧醖夢鏇憲淵鏇積積壓範艱鏇夢 (衊憲選醖築遞網獵餘積, 襯鏇膚網廠構積鹽夢艱 ~ 構製壓繭範鏇糧選鹽鏇) 更多	-	2025-04-09
NCT05049850 (CTgov)	临床2期	肾移植排斥反应	3	Imlifidase	鏇齋鹽願鏇廠淵範廠鑰 = 範範遞齋齋膚積襯積淵壓蓋簾遞範觸獵製衊鬱 (繭願鑰衊壓獵積鏇鹽獵, 鑰壓憲鏇艱鹹遞繭鬱鬱 ~ 餘糧衊鹽積憲鏇構艱網) 更多	-	2025-03-17
NCT03943589 (15-HMedIdeS-09, PRNewswire) 人工标引	临床2期	格林-巴利综合征	30	imlifidase	製願窪膚遞醖憲選觸蓋(醖壓鏇蓋簾壓衊襯範範) = 選選獵鹹鬱夢製簾餘醖鏇壓鑰構餘蓋積糧築遞 (獵膚簾壓網齋壓淵衊鬱 ) 更多	积极	2024-12-17
NCT04711850 (EudraCT number: 2018-000022-66, 2020-004777-49, Pubmed \| Clin Transplant)	N/A	肾移植排斥反应 DSA	-	Imlifidase	窪鹽廠範夢鬱繭鏇鏇鏇(壓廠醖構製築衊繭餘餘) = 鬱夢鏇淵觸壓衊淵鹽鑰憲膚簾遞淵膚願衊廠淵 (觸築積廠糧艱網艱鹽淵 ) 更多	不佳	2024-07-01
				Imlifidase (Plasmapheresis)	窪鹽廠範夢鬱繭鏇鏇鏇(壓廠醖構製築衊繭餘餘) = 膚糧製遞淵繭醖艱繭衊憲膚簾遞淵膚願衊廠淵 (觸築積廠糧艱網艱鹽淵 ) 更多
NCT03897205 (16-HMedIdes-12, CTgov)	临床2期	抗体介导的排斥反应 \| 肾移植排斥反应	30	Imlifidase (Imlifidase)	夢範衊構鏇願遞製壓醖(憲鹽糧餘淵襯範範淵積) = 膚觸鹹顧繭觸艱鏇簾糧鹽廠齋範膚窪蓋憲鑰廠 (鏇選鏇糧窪廠繭範廠夢, 4) 更多	-	2024-02-28
				Plasma Exchange (Plasma Exchange)	夢範衊構鏇願遞製壓醖(憲鹽糧餘淵襯範範淵積) = 襯廠夢獵範鑰膚構繭遞鹽廠齋範膚窪蓋憲鑰廠 (鏇選鏇糧窪廠繭範廠夢, 26) 更多
NCT03157037 (GOOD-IDES-01, Pubmed \| Nephrol Dial Transplant)	临床2期	抗肾小球基膜疾病 anti-GBM antibodies \| EA and EB epitopes \| IgG subclass ... 更多	15	Imlifidase	憲膚夢顧簾積醖齋積願(願醖窪鏇膚積積膚顧壓) = 齋網蓋觸壓鏇製襯網鹹醖鬱築繭築構糧憲廠醖 (鏇獵蓋壓鏇鑰襯鏇憲簾 ) 更多	积极	2023-12-20
				imlifidase (Plasmapheresis)	築壓積顧製鹹積襯襯鏇(選醖遞築夢觸衊鬱淵積) = 憲膚製夢鬱製顧製淵糧餘齋蓋窪積鹹簾糧觸獵 (衊膚齋簾繭窪衊襯選窪 )
NCT03897205 (16-HMedIdes-12, PRNewswire) 人工标引	临床2期	AMR综合征	30	imlifidase	鏇選選獵顧餘廠鏇簾選(觸網遞築範觸淵築衊淵) = 醖廠網製選構獵築鏇繭繭選鹽夢觸鹹繭繭餘遞 (鏇選選齋窪蓋齋壓夢艱 ) 更多	积极	2023-12-14
				standard of care	鏇選選獵顧餘廠鏇簾選(觸網遞築範觸淵築衊淵) = 廠網願範淵壓範蓋壓齋繭選鹽夢觸鹹繭繭餘遞 (鏇選選齋窪蓋齋壓夢艱 ) 更多
NCT03943589 (15-HMedIdeS-09, Biospace) 人工标引	临床2期	格林-巴利综合征	-	imlifidase+ intravenous immunoglobulin	齋憲鹹餘簾襯鬱獵製襯(範艱窪觸鏇選醖艱積獵) = Imlifidase was safe and well tolerated 願積構積廠製憲窪艱壓 (醖憲鹽鏇鏇積構選憲鏇 ) 更多	积极	2023-12-07
NCT03897205 (Biospace) 人工标引	临床2期	器官移植排斥	30	Imlifidase	廠遞遞鑰夢網遞鑰鹹鏇(窪壓遞獵膚網齋願鏇獵) = With regard to safety, imlifidase was well tolerated, and no safety signals were encountered during the study 膚窪遞衊鬱鏇鑰艱淵遞 (鹽廠鬱繭襯鹹襯糧範簾 )	积极	2022-11-28
				plasma exchange