汉莎生物制药发布2025年年度及可持续发展报告-动脉网

Hansa Biopharma publishes 2025 Annual and Sustainability Reports

PR Newswire 等信源发布 2026-03-26 15:21

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LUND, Sweden

瑞典隆德

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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BLA

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

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。

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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-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.

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

[email protected]

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

[email protected]

电子邮件地址

Notes to editors

编辑须知

About Hansa Biopharma

关于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.

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

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关注我们

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Forward-Looking Statements

前瞻性声明

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.

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 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.

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

https://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,c4326814

The following files are available for download:

以下文件可供下载：

https://mb.cision.com/Main/1219/4326814/4006377.pdf

Hansa 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