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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117

项与 Imlifidase 相关的文献（医药）

2026-05-05·BIOCHEMISTRY

Identification and Characterization of Novel Human IgG-Degrading Enzymes

Article

作者: Jones, David H. ; Appling, Francis D. ; Tran, Eileen ; Spraggon, Glen

The human immune response and factors that modulate it represent challenges and opportunities in many areas of medicine. Examples are the threat of transplant rejection and the reduction of this threat by the administration of a bacterially derived immune evasion enzyme. Streptococcus species secrete proteases of the IdeS/Mac family that efficiently degrade host immunoglobulin G (IgG) to help the bacteria evade the host's immune response. IdeS has recently received interest as a tool for transiently ablating circulating IgG in the context of diverse treatments, including transplantation and gene therapy. Given the wide-ranging utility of IdeS-mediated modulation of the human immune response, we sought to explore sequence-function relationships within the IdeS family in the hopes of identifying IdeS enzymes with therapeutic potential. To this end, we developed and applied a structural bioinformatics workflow and analytical strategy to identify and experimentally characterize novel IdeS homologs with activity against human IgG. Multiple IdeS-like enzymes with a range of human IgG degradation efficiencies were identified and characterized. The efficiencies of these enzymes exhibit a nontrivial dependence on the sequence of the IdeS-IgG binding site, highlighting the complexity of substrate recognition by IdeS. The workflow and data presented here inform basic IdeS enzymology, provide novel starting points for engineering IdeS variants for therapeutic use, and suggest general strategies for efficiently sampling protein sequence space to identify therapeutic enzymes.

2026-05-01·MOLECULAR THERAPY

Imlifidase enables AAV gene therapy in a seropositive Crigler-Najjar patient: On the verge of a paradigm shift

Article

作者: Perret, Gérald ; Do Cao, Jeremy ; Winstedt, Lena ; Knuchel-Legendre, Nathalie ; Labrune, Philippe ; Guyon, Hélène ; Gao-Desliens, Ji ; Ronzitti, Giuseppe ; Colpin, Claire ; Valent, Arnaud ; Leborgne, Christian

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.

122

项与 Imlifidase 相关的新闻（医药）

2026-05-28

·PRNewswire

Hansa Biopharma Announces Late-Breaking Abstract from ConfIdeS Phase 3 Trial Selected for Oral Presentation at ATC 2026

LUND, Sweden, May 26, 2026 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" (NASDAQ Stockholm: HNSA), today announced that results from its US Phase 3 ConfIdeS trial in kidney transplantation have been accepted and selected as a late-breaking abstract for an oral presentation at the upcoming American Transplant Congress (ATC) in Boston, June 22, 2026. The presentation will include detailed 12-month results from the ConfIdeS trial, including the primary endpoint eGFR, key secondary endpoints as well as safety results. The presentation will be delivered by Dr Robert Montgomery, MD PhD, New York University Langone Transplant Institute and investigator in the ConfIdeS trial. Title: Superior 1-year eGFR Among Highly Sensitized Patients Desensitized with Imlifidase Compared with Control Abstract Number: 730 Presenter: Dr Robert Montgomery on behalf of the ConfIdeS study group Session Title: Late-Breaking Abstracts: Clinical Science Date/Time: Monday June 22, 2026, 15:57 PM-16:09 PM EDT Location: 253-BC, Level 2, Thomas Michael Menino Convention and Exhibition Center Contacts for more information: Kerstin Falck, VP Global Corporate Affairs [email protected] [email protected] Notes to editors About highly sensitized patients Highly sensitized patients have pre-formed antibodies called donor specific antibodies (DSAs) with a broad reactivity against human leukocyte antigens (HLAs), which can cause tissue damage and potentially transplant rejection.1 The presence of DSAs means that highly sensitized patients tend to have limited or no access to transplant, as finding a compatible donor organ can be particularly challenging.2,3 The complexity of their immunological profile means that highly sensitized patients spend longer time than average on transplant waiting lists, with evidence showing that this longer time waiting for a suitable donor relates to an increased mortality risk.4,5 Across the U.S. and Europe, highly sensitized patients comprise around 10-15% of the total of patients on transplant waiting lists.6,7 About imlifidase Imlifidase is conditionally approved in the European Union, Norway, Liechtenstein, Iceland and the UK under the tradename IDEFIRIX® for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. IDEFIRIX® is also approved in Australia, Israel and Switzerland. Information about the trial is available at ClinicalTrials.gov: NCT04935177 About IDEFIRIX ® (imlifidase) Imlifidase is an antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets and cleaves immunoglobulin G (IgG) antibodies and inhibits IgG-mediated immune response.8 It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration. Imlifidase has conditional marketing approval in Europe and is marketed under the trade name IDEFIRIX for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. The use of IDEFIRIX should be reserved for patients who are unlikely to be transplanted under the available kidney allocation system, including prioritization programs for highly sensitized patients.8 IDEFIRIX was reviewed as part of the European Medicines Agency's (EMA) PRIority Medicines (PRIME) program, which supports medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options.8 The efficacy and safety of imlifidase as a pre-transplant treatment to reduce donor-specific IgG antibodies was studied in four phase 2 single-arm, studies in EU and US as well as a randomized, controlled Phase 3 study in US.5,7,10-11 Hansa is collecting further clinical evidence and will submit additional efficacy and safety data based on one observational follow-up study and one post-approval efficacy study. In the US, the Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for imlifidase in February of 2026 and assigned a Prescription Drug User Fee Act (PDUFA) action date of December 19, 2026. Full EU product information can be accessed via the initial Summary of Product Characteristics found here. About kidney failure Kidney disease can progress to kidney failure or End-Stage Renal Disease (ESRD), identified when a patient's kidney function is less than 15%.12 ESRD poses a significant health burden, affecting nearly 2.5 million patients worldwide.12 A kidney transplant is the treatment of choice for suitable patients with ESRD because it offers improved survival and quality of life benefits, and is cost savings compared to long-term dialysis. There are approximately 170,000 kidney patients in the U.S. and Europe waiting for a new kidney.13 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. References Eurostam Report (A Europe-wide strategy to enhance transplantation of highly sensitized patients on the basis of acceptable HLA mismatches.) Available at . Redfield RR, et al. The mode of sensitization and its influence on allograft outcomes in highly sensitized kidney transplant recipients. Nephrol Dial Transplant. 2016 Oct;31(10):1746-53. doi: 10.1093/ndt/gfw099. Lonze BE, et al. IdeS (Imlifidase): A Novel Agent That Cleaves Human IgG and Permits Successful Kidney Transplantation Across High-strength Donor-specific Antibody. Ann Surg. 2018 Sep;268(3):488-496. doi: 10.1097/ Alelign T, Ahmed MM, Bobosha K, Tadesse Y, Howe R, Petros B. Kidney Transplantation: The Challenge of Human Leukocyte Antigen and Its Therapeutic Strategies. J Immunol Res. 2018 Mar 5;2018:5986740. Available at: Heidt S, et al. Highly Sensitized Patients are Well Serves by Recieving a Compatible Organ Offer Based on Acceptable Mismatches. Front Immunol. 2021;12:687254. Available at: Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR). OPTN/SRTR 2022 Annual Data Report. U.S. Department of Health and Human Services, Health Resources and Services Administration; 2024. Accessed [June 2024]. Jordan SC, et al. Imlifidase Desensitization in Crossmatch-positive, Highly Sensitized Kidney Transplant Recipients: Results of an International Phase 2 Trial (Highdes). Transplantation. 2021 Aug 1;105(8):1808-1817. doi: 10.1097/TP.0000000000003496. European Medicines Agency. Idefirix® summary of product characteristics. Available at: . Jordan SC, et al. IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation. N Engl J Med 2017;377:442-453. DOI: 10.1056/NEJMoa16125 1Winstedt L, et al. Complete Removal of Extracellular IgG Antibodies in a Randomized Dose-Escalation Phase I Study with the Bacterial Enzyme IdeS--A Novel Therapeutic Opportunity. PLoS One. 2015 Jul 15;10(7):e0132011. doi: 10.1371/journal.pone.0132011. PMID: 26177518; PMCID: PMC4503742. Lorant T, et al. Safety, immunogenicity, pharmacokinetics, and efficacy of degradation of anti-HLA antibodies by IdeS (imlifidase) in chronic kidney disease patients. Am J Transplant. 2018 Nov;18(11):2752-2762. doi: 10.1111/ajt.14733. NIH (2018). What is kidney failure? Available at: Newsletter Transplant 2022. International figures on donation and transplantation. Available at: Newsletter Transplant - latest edition I Freepub (edgm.eu) Accessed: May 2024 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期上市批准临床2期临床结果免疫疗法

2026-05-19

·Innodrugs

1.1亿欧首付，Hansa Biopharma 与 SERB Pharmaceuticals 达成 IgG 单抗合作协议

2026年5月19日，瑞典隆德，Hansa Biopharma AB（下称Hansa）与SERB S.A.今日达成独家授权协议，授予对方IDEFIRIX (imlifidase)在欧盟、英国、瑞士、挪威、列支敦士登、冰岛及中东和北非地区的研发与商业化权益。 IDEFIRIX为全球首创疗法，可在2至6小时内特异性裂解所有类型免疫球蛋白G(IgG)抗体。该药物已获欧盟委员会附条件批准，用于群体反应性抗体阳性、高度致敏成人肾移植受者的移植脱敏治疗，是满足巨大未满足临床需求的突破性创新药物。 Hansa Biopharma首席执行官Renée Aguiar-Lucander表示：“本次合作对公司发展具备里程碑意义。借助合作方成熟的欧洲商业化布局与稳健发展实力，可让当地患者尽早用上这款药物。同时此次合作充分兑现了该产品资产价值，大幅优化公司财务状况。若2026年顺利拿下美国市场获批，将助力产品在美国顺利上市、推动公司实现盈利目标，也能让公司持续推进在研管线研发。” SERB董事长Jeremie Urbain称：“目前高度致敏移植患者临床治疗选择十分有限，SERB致力于扩大移植领域创新药物的可及性。公司深耕罕见病与急症领域，将依托自身在欧洲及中东北非地区深厚的行业经验、成熟商业化运营能力与完善平台，进一步拓宽IDEFIRIX的应用范围，提升其临床应用价值。” SERB是一家民营全球专科制药企业，拥有超25年罕见病、突发重症及医疗应急药物研发运营经验。公司业务覆盖18个国家，在售产品超70款，员工规模超600人，并购整合经验丰富，是具备全产业链实力、秉持价值增长理念的优质合作方。根据协议条款，Hansa授予SERB在上述区域内独家开展IDEFIRIX移植领域研发及商业化的权益。Hansa将获得1.1亿欧元首付款，欧洲药品管理局受理该药物完整上市申请后，还将额外获得500万欧元款项。在上市后疗效确证研究核心数据公布后，Hansa将全力协助合作方完成申报与审评工作。交易完成后，SERB取得上市许可持有人资质，承接该药物长期上市后疗效随访研究以及正在开展的儿科临床试验相关工作，相关交接工作将在交易落地后即刻启动。关于imlifidase imlifidase已在欧盟、挪威、列支敦士登、冰岛及英国以IDEFIRIX®为商品名获得附条件批准，用于群体反应性抗体阳性的高度致敏成人肾移植患者脱敏治疗，同时该药物也已在澳大利亚与瑞士获批上市。临床试验信息可查阅ClinicalTrials.gov：NCT04935177 关于IDEFIRIX® (imlifidase) imlifidase是源自化脓性链球菌的抗体裂解酶，能够特异性裂解免疫球蛋白G抗体，抑制该类抗体介导的免疫排斥反应。药物起效迅速，给药后数小时内即可裂解免疫球蛋白G抗体并阻断其作用。该药物通过欧盟优先药物计划审评，该计划专门扶持相比现有疗法具备显著治疗优势、可填补临床治疗空白的创新药物。此前企业已在欧美完成四项II期单臂临床试验以及一项美国III期随机对照临床试验，充分验证该药物作为移植术前用药、降低供体特异性抗体水平的疗效与安全性。目前企业仍在收集更多临床证据，除上市后疗效研究外，还将依托一项观察性随访研究补充更多疗效与安全数据。美国方面，FDA已于2026年2月受理该药物生物制品许可申请，设定处方药使用者付费法案审评决议目标日期为2026年12月19日。欧盟完整药品说明书可通过官方产品概要页面查询。关于肾功能衰竭肾脏疾病持续进展可发展为终末期肾病，即患者肾功能降至15%以下，该病症全球患者数量近250万，疾病负担沉重。对于符合手术指征的终末期肾病患者，肾移植是首选治疗方案，不仅能延长生存期、提升生活质量，长期治疗成本也远低于透析疗法。目前欧美地区等待肾源移植的患者约达17万人。关于Hansa Biopharma Hansa Biopharma是一家已实现产品商业化运营的前沿生物制药企业，专注研发及商业化新型免疫调节疗法，革新急性及复杂性免疫疾病治疗方案。公司自研免疫球蛋白G抗体裂解酶技术平台，可有效解决器官移植、基因治疗及自身免疫性疾病领域诸多未满足临床需求。公司核心产品imlifidase作为全球首创免疫球蛋白G抗体裂解酶药物，可助力高度致敏患者顺利完成肾移植；新一代同靶点在研分子HNSA-5487，规划用于吉兰-巴雷综合征治疗。企业总部设于瑞典隆德，业务布局覆盖欧美两地，于斯德哥尔摩纳斯达克交易所上市，股票代码HNSA。

并购引进/卖出上市批准申请上市临床研究

2026-05-19

·PRNewswire

Hansa Biopharma enters into €115 million licensing agreement with SERB Pharmaceuticals for IDEFIRIX in Europe and MENA

The agreement covers the European Union, United Kingdom, Switzerland, Norway, Liechtenstein, Iceland and the MENA region Significantly enhances Hansa's financial position, ensuring a robust U.S. launch and provides path to profitability, subject to US approval SERB has a substantial European commercial presence and a successful track record in critical care and rare disease commercialization LUND, Sweden, May 19, 2026 /PRNewswire/ -- Hansa Biopharma AB ("Hansa" or "the Company") (NASDAQ STOCKHOLM: HNSA) and SERB S.A. ("SERB") today announced an exclusive licensing agreement for development and commercialization of IDEFIRIX (imlifidase) in the European Union (EU), United Kingdom (UK), Switzerland, Norway, Liechtenstein, Iceland and MENA (Middle East and North Africa) regions. IDEFIRIX is a first-in-class treatment that specifically targets and cleaves all classes of immunoglobulin G (IgG) antibodies within 2 to 6 hours. It is conditionally authorized by the European Commission for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch test against an available deceased donor. IDEFIRIX offers a pioneering breakthrough for patients with a significant unmet medical need. Renée Aguiar-Lucander, CEO of Hansa Biopharma, said "This agreement is transformative for Hansa Biopharma. It allows patients in the region to benefit from a partner with an established commercial footprint and proven growth track record in Europe. At the same time, it crystallizes the value of the franchise and significantly strengthens our financial position assuring an optimized US launch and a pathway to profitability, subject to a 2026 US approval, as well as the continued pursuit of our R&D pipeline." Jeremie Urbain, Chairman of SERB, said "SERB is committed to expanding access to transplantation for highly sensitized patients who currently have very limited alternatives. SERB is designed to address rare and urgent conditions, and will leverage its deep expertise, proven commercial execution and established platform across Europe and MENA to expand the reach and clinical impact of IDEFIRIX." SERB is a, privately owned, global specialty pharmaceutical company with 25+ years of experience in rare diseases, rare medical emergencies and medical countermeasures. With over 70 products across commercial operations in 18 countries, more than 600 employees and a strong M&A track record, SERB is a fully integrated partner with proven, value-driven growth. Under the agreement, Hansa has granted SERB an exclusive EU, UK, Switzerland, Norway, Liechtenstein, Iceland and MENA license for development and commercialization of IDEFIRIX in transplantation . Hansa will receive an upfront payment of €110 million and a €5 million payment upon acceptance of the filing for full approval of IDEFIRIX by the European Medicines Agency (EMA). Hansa will fully support SERB in the filing and EMA review process following the reporting of the Post-Authorization Efficacy Study (PAES) topline data. SERB will assume responsibility for the long-term PAES follow-up and the ongoing paediatric study upon obtaining Market Authorization Holdership, a process expected to be initiated immediately following the closing of the transaction. Completion of the transaction is subject to customary conditions, including required foreign direct investment (FDI) regulatory approval, and is expected to be completed within 60 days. Centerview Partners UK LLP is acting as exclusive financial advisor and Morgan Lewis is acting as legal counsel to Hansa. Rothschild & Co. is acting as exclusive financial advisor and Freshfields is acting as legal counsel to SERB. Conference Call Details Hansa Biopharma will host a telephone conference today Monday, May 19, 2026, at 15:00 CEST / 9:00 am EDT. The event will be hosted by Renée Aguiar-Lucander, CEO and Evan Ballantyne, CFO. The call will be held in English. Slides used in the presentation will be live on the webcast during the call and will also be made available online after the call under Events and presentations | Hansa Biopharma To participate in the telephone conference, please use the dial-in details provided below: Participant Dial In (USA/Canada Toll Free): 1-833-821-3542 Participant International Dial In: 1-412-652-1248 *Please ask to be joined into the Hansa Biopharma call Join the webcast here: Webcast | Hansa Biopharma Call This is information that Hansa Biopharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 07:30 CEST on May 19, 2026. Contacts for more information: Kerstin Falck, VP Global Corporate Affairs [email protected] [email protected] Notes to editors About imlifidase Imlifidase is conditionally approved in the European Union, Norway, Liechtenstein, Iceland and the UK under the tradename IDEFIRIX® for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. IDEFIRIX® is also approved in Australia and Switzerland. Information about the trial is available at ClinicalTrials.gov: NCT04935177 About IDEFIRIX ® (imlifidase) Imlifidase is an antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets and cleaves immunoglobulin G (IgG) antibodies and inhibits IgG-mediated immune response.1 It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration. Imlifidase has conditional marketing approval in Europe and is marketed under the tradename IDEFIRIX for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. The use of IDEFIRIX should be reserved for patients who are unlikely to be transplanted under the available kidney allocation system, including prioritization programs for highly sensitized patients.1 IDEFIRIX was reviewed as part of the European Medicines Agency's (EMA) PRIority Medicines (PRIME) program, which supports medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options.1 The efficacy and safety of imlifidase as a pre-transplant treatment to reduce donor-specific IgG antibodies was studied in four Phase 2 single-arm studies in EU and US as well as a randomized, controlled Phase 3 study in US2,3-5. Hansa is collecting further clinical evidence and will submit additional efficacy and safety data based on one observational follow-up study in addition to the above described post-approval efficacy study. In the US, the Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for imlifidase in February of 2026 and assigned a Prescription Drug User Fee Act (PDUFA) action date of December 19, 2026. Full EU product information can be accessed via the initial Summary of Product Characteristics found here. About kidney failure Kidney disease can progress to kidney failure or End-Stage Renal Disease (ESRD), identified when a patient's kidney function is less than 15%.6 ESRD poses a significant health burden, affecting nearly 2.5 million patients worldwide.6 A kidney transplant is the treatment of choice for suitable patients with ESRD because it offers improved survival and quality of life benefits, and is cost savings compared to long-term dialysis. There are approximately 170,000 kidney patients in the US and Europe waiting for a new kidney.7 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. References European Medicines Agency. Idefirix® summary of product characteristics. Available at: . Heidt S, et al. Highly Sensitized Patients are Well Serves by Receiving a Compatible Organ Offer Based on Acceptable Mismatches. Front Immunol. 2021;12:687254. Available at: Jordan SC, et al. IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation. N Engl J Med. 2017 Aug 3;377(5):442-453. doi: 10.1056/NEJMoa1612567. Erratum in: N Engl J Med. 2017 Oct 26;377(17):1700. doi: 10.1056/NEJMx170015. Winstedt L, et al. Complete Removal of Extracellular IgG Antibodies in a Randomized Dose-Escalation Phase I Study with the Bacterial Enzyme IdeS--A Novel Therapeutic Opportunity. PLoS One. 2015 Jul 15;10(7):e0132011. doi: 10.1371/journal.pone.0132011. PMID: 26177518; PMCID: PMC4503742. Lorant T, et al. Safety, immunogenicity, pharmacokinetics, and efficacy of degradation of anti-HLA antibodies by IdeS (imlifidase) in chronic kidney disease patients. Am J Transplant. 2018 Nov;18(11):2752-2762. doi: 10.1111/ajt.14733. NIH (2018). What is kidney failure? Available at: . Newsletter Transplant 2022. International figures on donation and transplantation. Available at: Newsletter Transplant - latest edition I Freepub (edgm.eu) Accessed: May 2025 This information was brought to you by Cision The following files are available for download: 21% more press release views with Request a Demo

临床3期引进/卖出上市批准临床1期

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

适应症

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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	繭選淵艱網夢壓顧觸繭(構廠壓鑰範願淵壓襯選) = 醖遞衊鹹壓選簾鏇廠淵糧廠繭遞憲觸觸網鬱網 (廠齋衊鹹鑰襯繭餘艱淵 ) 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	壓壓願選簾餘繭蓋獵繭(積鹽壓遞製築鹹獵觸選) = 顧齋艱觸糧願鏇膚艱築衊襯遞鹽廠構襯簾願餘 (網鬱願網鬱構壓鏇網觸, 淵鏇窪餘窪窪簾積簾淵 ~ 醖齋積構艱願廠鬱艱網) 更多	-	2025-04-09
NCT05049850 (CTgov)	临床2期	肾移植排斥反应	3	Imlifidase	蓋遞壓鏇齋衊廠構顧衊 = 廠積糧廠窪遞繭窪遞憲鹽築糧蓋製鹽簾餘淵遞 (鏇遞鏇廠鹹鑰遞鑰鏇製, 簾選鏇鏇鏇艱築積觸鹹 ~ 繭簾繭積獵襯襯鹽艱選) 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	顧構範淵網艱鏇願夢齋(築憲窪憲壓糧鬱憲選觸) = 壓網築餘築選構鏇餘憲衊網鹽齋糧壓築範鹽夢 (網衊淵艱艱獵壓淵簾齋 ) 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	糧憲遞鏇繭餘窪積廠淵(鏇鹹醖簾蓋選艱觸淵簾) = 願夢壓窪衊鏇鹽膚衊獵鹽獵構蓋繭夢蓋齋簾壓 (選獵顧遞壓憲醖糧鬱醖 ) 更多	不佳	2024-07-01
				Imlifidase (Plasmapheresis)	糧憲遞鏇繭餘窪積廠淵(鏇鹹醖簾蓋選艱觸淵簾) = 鬱膚繭製顧鹹遞鬱鑰鬱鹽獵構蓋繭夢蓋齋簾壓 (選獵顧遞壓憲醖糧鬱醖 ) 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)	簾窪築製鹽築構鏇願淵(簾簾觸衊夢廠簾構範衊) = 範範觸積網淵齋鹹遞艱鑰憲窪願遞鏇積淵餘衊 (膚鑰淵窪醖繭夢鏇淵選, 4) 更多	-	2024-02-28
				Plasma Exchange (Plasma Exchange)	簾窪築製鹽築構鏇願淵(簾簾觸衊夢廠簾構範衊) = 鑰餘繭鑰顧遞醖製襯簾鑰憲窪願遞鏇積淵餘衊 (膚鑰淵窪醖繭夢鏇淵選, 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	顧壓夢築艱繭積艱艱鹹(選鏇夢憲窪蓋遞鏇淵築) = 選簾醖夢獵簾網製鑰蓋壓鏇遞齋範鑰膚繭構顧 (網窪築顧獵醖製夢淵繭 ) 更多	积极	2023-12-20
				imlifidase (Plasmapheresis)	選網積衊廠衊簾鏇廠壓(鏇糧淵網夢鑰積齋鏇醖) = 餘醖範壓構醖鏇蓋鬱鹹醖顧膚築網顧築衊遞範 (積艱窪構糧獵衊簾壓壓 )
NCT03897205 (16-HMedIdes-12, PRNewswire) 人工标引	临床2期	AMR综合征	30	imlifidase	淵構鏇衊糧壓衊網築齋(糧獵醖獵壓網憲遞鹽願) = 襯鹹膚願窪憲選製齋遞艱選鏇範觸淵鹹齋鏇顧 (網廠築艱壓積範觸選範 ) 更多	积极	2023-12-14
				standard of care	淵構鏇衊糧壓衊網築齋(糧獵醖獵壓網憲遞鹽願) = 鑰齋窪製廠願壓憲鑰鏇艱選鏇範觸淵鹹齋鏇顧 (網廠築艱壓積範觸選範 ) 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	膚鹹膚廠繭鹽繭願糧選(簾獵齋積膚醖膚鑰憲餘) = Imlifidase was safe and well tolerated 鹹齋選餘膚觸衊淵蓋壓 (鹹簾壓醖鬱願鹹襯願獵 ) 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	顧鑰簾構衊鏇鬱憲壓鑰(網願鹹鹽積衊糧獵衊願) = With regard to safety, imlifidase was well tolerated, and no safety signals were encountered during the study 遞鏇蓋築糧鏇襯範製鏇 (構構衊齋夢顧鏇觸醖遞 )	积极	2022-11-28
				plasma exchange