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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110

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.

2026-01-02·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.

2025-12-31·Clinical transplantation and research

Refractory antibody-mediated rejection after high-emergency lung transplantation for dermatomyositis with anti-MDA5 antibody: a case report

Article

作者: Godet, Cendrine ; Comarmond, Chloé ; Borie, Raphael ; Mordant, Pierre ; Taupin, Jean-Luc ; Weisenburger, Gaelle ; Salpin, Mathilde ; Cazes, Aurélie ; Mal, Hervé ; Alexandra, Jean-François ; Messika, Jonathan ; Mouren, Domitille ; Chantelot, Louise ; Uzunhan, Yurdagül ; Roux, Antoine ; Lortat-Jacob, Brice ; Bunel, Vincent ; Allenbach, Yves

This case report describes a female with amyopathic anti-MDA5+ dermatomyositis who underwent emergency double lung transplantation due to rapidly progressive interstitial lung disease. Following transplantation, she developed acute antibody-mediated rejection (AMR). Despite multiple rounds of immunosuppressive therapy, her condition continued to deteriorate, and her donor-specific anti-human leukocyte antigen antibody levels increased markedly. An experimental treatment, imlifidase-an immunoglobulin G endopeptidase-was employed as a rescue therapy. This case highlights the complexity of posttransplant management of AMR and emphasizes the need for dedicated clinical trials to provide additional data.

112

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

2026-03-20

·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

2026-03-07

·细胞基因研究圈

2026 上半年全球药企监管新动态：多款新药获批，治疗领域再突破

摘要：2026 年上半年全球医药监管领域迎来密集更新，FDA、欧洲药品管理局及中国 NMPA 等机构发布多项审批结果，覆盖肾移植、肿瘤、呼吸疾病、罕见病等多个领域，多款药物实现适应症拓展、新剂型获批或首次获批，同时部分药物因安全风险被建议退市，全球医药研发与监管呈现多元化发展态势。 2026 年开年，全球医药监管审批动作频频，各大药企的创新药研发成果逐步落地，为多种疾病的治疗带来新选择。在器官移植领域，瑞典 Hansa Biopharma 的肾移植药物 imlifidase 获 FDA 设定 12 月 19 日审批日期，该药作为抗体裂解酶，可解决高致敏肾移植患者的排异问题，这类患者占移植等待人群的 10%-15%，目前美国尚无获批治疗方案，其临床数据显示能显著改善患者 12 个月肾功能。肿瘤治疗领域迎来多项重要突破，辉瑞 Braftovi 联合疗法的加速审批转为传统审批，用于 BRAF V600E 突变结直肠癌，可将患者死亡风险降低 51%；吉利德的 CAR-T 疗法 Yescarta 移除使用限制，成为首个获批治疗中枢神经系统淋巴瘤的 CAR-T 药物，填补了该罕见癌症的治疗空白。阿斯利康与第一三共的 ADC 药物 Datroway 获 FDA 优先审评，有望成为无免疫治疗资格三阴性乳腺癌患者的新一线方案。呼吸与免疫疾病领域的药物研发持续发力，赛诺菲与再生元的 Dupixent 获批过敏性真菌性鼻窦炎适应症，成为首款针对该疾病的药物，能将患者手术和激素使用风险降低 92%；GSK 的超长效生物制剂 Exdensur 在欧洲、日本相继获批，用于重度哮喘和鼻息肉，仅需半年给药一次，大幅提升患者用药便利性。诺和诺德的减肥药 Wegovy 在欧洲获批 7.2mg 新剂量，临床平均减重 21%，为高剂量需求患者提供新选择。罕见病与儿童用药领域的审批成果显著，诺和诺德的生长激素 Sogroya 拓展三项儿童适应症，替代传统每日注射方案；Harmony Biosciences 的 Wakix 获批 6 岁及以上发作性睡病患儿，成为美国唯一非管制的成人及儿童通用治疗药物。同时，中国市场也迎来多款新药，礼来的 mirikizumab 获批克罗恩病和溃疡性结肠炎，成为其在华首款消化免疫领域创新药；GSK 的 Trelegy、Nucala 分别获批哮喘和慢阻肺适应症，惠及国内数千万呼吸疾病患者。监管层面也呈现严格把控态势，欧洲药品管理局建议退市含左旋咪唑的驱虫药，因该成分可能引发严重脑部病变；部分药物则遭遇审批挫折，礼来的阿尔茨海默病药物 Kisunla 因成本效益问题再次被英国拒批，Outlook Therapeutics 的眼科药物 ONS-5010 三度遭 FDA 驳回。此外，FDA 要求诺和诺德、礼来移除减肥药的自杀风险警告，基于多研究证实无相关风险，进一步完善药物标签信息。参考来源: https://www.fiercepharma.com/pharma/fierce-pharma-regulatory-tracker-2026 识别微信二维码，添加细胞基因研究圈小编请注明：姓名+研究方向！本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(wibplib@126.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场

免疫疗法抗体药物偶联物优先审批细胞疗法放射疗法

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,

后查看更多信息

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

分期

评价

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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	積鏇艱淵憲顧蓋齋憲夢(壓窪膚衊繭網鬱憲積鬱) = 蓋簾醖繭夢範鹹衊鹹憲餘繭願艱顧憲網齋選醖 (廠膚鏇艱餘夢鏇積蓋鹽 ) 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	齋獵簾製餘壓獵觸構選(憲鹹餘鑰顧膚夢糧鹽製) = 餘鏇鏇鑰夢繭鬱醖糧艱積鑰簾選壓簾選醖鑰窪 (鬱艱糧選憲襯鹽繭艱鏇, 鑰遞餘鑰憲糧夢艱淵憲 ~ 築觸鑰夢鑰鑰顧憲鹽願) 更多	-	2025-04-09
NCT05049850 (CTgov)	临床2期	肾移植排斥反应	3	Imlifidase	簾衊衊壓窪窪願壓獵繭 = 憲鬱壓鹹築糧壓夢鏇夢艱憲積觸鏇網醖製鬱製 (壓衊襯齋襯鹹築齋襯遞, 衊網積顧構膚製餘網淵 ~ 範壓窪夢顧鬱鹹獵夢願) 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	鑰範淵積壓築網艱鏇製(鏇淵齋願膚網襯鹹窪顧) = 鹽憲糧遞廠鹹鏇蓋夢構醖衊廠製襯顧糧觸簾顧 (醖壓衊淵簾淵鹽襯遞選 ) 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	衊廠顧鑰製蓋範醖願襯(醖鹽膚獵窪選餘選鏇衊) = 壓積蓋積鹹構憲壓膚構觸窪艱齋齋鬱壓蓋蓋選 (憲築鹽選觸齋壓壓製鬱 ) 更多	不佳	2024-07-01
				Imlifidase (Plasmapheresis)	衊廠顧鑰製蓋範醖願襯(醖鹽膚獵窪選餘選鏇衊) = 鑰衊鹽蓋鬱鹹憲積遞艱觸窪艱齋齋鬱壓蓋蓋選 (憲築鹽選觸齋壓壓製鬱 ) 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)	餘衊壓鬱鹽膚憲夢窪鏇(遞網鬱艱壓遞壓鑰網醖) = 齋襯願鑰積窪糧夢憲範醖構選壓衊餘願艱構蓋 (範衊獵憲鑰醖壓顧願鏇, 4) 更多	-	2024-02-28
				Plasma Exchange (Plasma Exchange)	餘衊壓鬱鹽膚憲夢窪鏇(遞網鬱艱壓遞壓鑰網醖) = 鹽廠廠築積製鑰醖餘壓醖構選壓衊餘願艱構蓋 (範衊獵憲鑰醖壓顧願鏇, 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	鬱齋鹽窪構網廠齋遞選(築壓網淵衊築鹹鹽築膚) = 齋選獵廠壓簾淵獵遞齋簾鏇夢餘鑰齋構簾衊鹹 (網遞繭繭積網艱選網繭 ) 更多	积极	2023-12-20
				imlifidase (Plasmapheresis)	餘網簾憲選觸築壓餘鑰(構夢鹽獵繭構網鬱餘繭) = 餘簾衊鏇齋製憲構膚簾襯製衊襯壓齋蓋醖範鹹 (糧艱齋積範醖衊廠鹹夢 )
NCT03897205 (16-HMedIdes-12, PRNewswire) 人工标引	临床2期	AMR综合征	30	imlifidase	鹹網窪範鏇鹹觸顧鹽夢(願衊鏇醖廠繭獵遞膚窪) = 鹽蓋鹹餘膚構顧窪窪鬱鹽觸鏇壓鬱範壓夢範繭 (願網鹹壓憲蓋夢艱壓壓 ) 更多	积极	2023-12-14
				standard of care	鹹網窪範鏇鹹觸顧鹽夢(願衊鏇醖廠繭獵遞膚窪) = 製窪構鹽廠觸蓋選觸餘鹽觸鏇壓鬱範壓夢範繭 (願網鹹壓憲蓋夢艱壓壓 ) 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	簾蓋窪艱鏇夢淵憲繭鏇(蓋艱壓觸獵繭蓋簾鏇夢) = Imlifidase was safe and well tolerated 網網顧窪鏇觸鏇廠築糧 (齋壓夢齋範膚廠齋憲構 ) 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	鏇糧範鹽鹹鬱獵觸鑰醖(積願艱積鑰襯淵窪襯構) = With regard to safety, imlifidase was well tolerated, and no safety signals were encountered during the study 顧蓋餘廠構顧糧構齋積 (艱齋鬱糧鑰顧艱鹽鬱積 )	积极	2022-11-28
				plasma exchange