Hansa Biopharma宣布与 SERB Pharmaceuticals就 Idefirix在欧洲及中东和北非地区达成价值 1.15亿欧元的许可交易并完成交割-动脉网

Hansa Biopharma announces closing of €115 million licensing transaction with SERB Pharmaceuticals for Idefirix in Europe and MENA

PR Newswire 等信源发布 2026-07-01 21:15

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SERB assumes responsibility for the commercialization of Idefirix in transplantation in the EU, UK, Switzerland, Norway, Liechtenstein, Iceland and MENA region

SERB 负责 Idefirix 在欧盟、英国、瑞士、挪威、列支敦士登、冰岛以及中东和北非（MENA）地区移植领域的商业化。

The transaction significantly strengthens Hansa's financial position and enables a robust US launch,

该交易显著增强了汉萨公司的财务实力，并为其在美国市场的强劲发布奠定了基础。

subject to US approval of imlifidase

须待美国批准伊米苷酶

LUND, Sweden

瑞典，隆德

，

July 1, 2026

2026年7月1日

/PRNewswire/ -- Hansa Biopharma AB ('Hansa' or 'the Company') (NASDAQ Stockholm: HNSA) and SERB S.A. ('SERB') today announced required regulatory approvals have been obtained and that the previously announced exclusive licensing transaction with SERB has closed.

/美通社/ -- Hansa Biopharma AB（“Hansa”或“公司”）（纳斯达克斯德哥尔摩交易所：HNSA）与SERB S.A.（“SERB”）今日宣布，已获得所需的监管批准，此前宣布的与SERB的独家许可交易已完成交割。

Under the agreement, Hansa has granted SERB an exclusive license for the development and commercialization of Idefirix in solid organ transplantation in the European Union (EU), United Kingdom (UK), Switzerland, Norway, Liechtenstein, Iceland and the MENA (Middle East and North Africa) region. The total transaction value is €115 million, comprising 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..

根据协议，Hansa授予SERB在欧盟（EU）、英国（UK）、瑞士、挪威、列支敦士登、冰岛以及中东和北非（MENA）地区开发和商业化Idefirix用于实体器官移植的独家许可。交易总价值为1.15亿欧元，包括1.1亿欧元的首付款，以及在欧洲药品管理局受理Idefirix完整批准申请后支付的500万欧元。

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 是一种首创疗法，可在 2 至 6 小时内特异性靶向并裂解所有类别的免疫球蛋白 G（IgG）抗体。欧盟委员会已对其授予附条件上市许可，用于对交叉配型试验呈阳性、且有可用已故捐献者肾脏的高度致敏成人肾移植患者进行脱敏治疗。

Idefirix offers a pioneering breakthrough for patients with a significant unmet medical need..

Idefirix 为存在重大未满足医疗需求的患者提供了开创性的突破。

Renée Aguiar-Lucander, CEO of Hansa Biopharma, said:

Hansa Biopharma 首席执行官 Renée Aguiar-Lucander 表示：

'The closing of this transaction marks an important milestone for Hansa. With SERB as our partner in Europe and MENA, we believe Idefirix will benefit from additional expertise, reach and resources to enable access for appropriate highly sensitized kidney transplant patients, addressing a significant unmet medical need.

“本次交易的完成标志着汉萨公司的重要里程碑。随着SERB成为我们在欧洲和中东及北非地区的合作伙伴，我们相信Idefirix将受益于额外的专业知识、市场覆盖和资源，从而为合适的高度致敏肾移植患者提供药物可及性，解决一个重大的未满足医疗需求。”

At the same time, the transaction strengthens Hansa's financial position as we continue to prepare for a potential US launch of imlifidase, subject to US approval, and advance our broader R&D pipeline.' .

与此同时，随着我们继续为伊米福酶（imlifidase）在美国的潜在上市做准备（须获得美国监管机构批准），并推进更广泛的研发管线，此次交易也巩固了Hansa的财务地位。

SERB is a privately owned, global speciality 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..

SERB 是一家私有跨国 specialty 制药公司，在罕见病、罕见医疗急症和医疗对策领域拥有超过25年的经验。公司在18个国家开展商业化运营，拥有70多种产品，员工人数超过600人，并具备强大的并购记录，是一家完全整合的合作伙伴，具有经过验证的价值驱动增长能力。

Hansa will apply to the EMA for transfer of the Market Authorization of Idefirix to SERB and continue to fully support SERB in the filing for conversion to full approval and the EMA review process based on the outcome of the Post-Authorization Efficacy Study topline data announced May 27. SERB will assume responsibility for the long-term PAES follow-up and the ongoing paediatric study upon obtaining Market Authorization Holdership..

汉莎公司将向欧洲药品管理局（EMA）申请将Idefirix的市场授权转让给SERB，并将继续全力支持SERB基于5月27日公布的上市后有效性研究（PAES）顶层数据结果，提交转为完全批准的申请并参与EMA的审评流程。SERB在获得市场授权持有人资格后，将承担长期PAES随访及正在进行的儿科研究的责任。

Centerview Partners UK LLP acted as exclusive financial advisor and Morgan Lewis acted as legal counsel to Hansa.

Centerview Partners UK LLP 担任汉莎公司的独家财务顾问，Morgan Lewis 担任其法律顾问。

Rothschild & Co. acted as exclusive financial advisor and Freshfields acted as legal counsel to SERB.

罗斯柴尔德公司担任独家财务顾问，弗莱士律师事务所担任塞尔维亚共和国储蓄银行（SERB）的法律顾问。

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 14:30 CEST on July 1, 2026.

这是汉莎生物制药公司（Hansa Biopharma AB (publ)）根据欧盟《市场滥用条例》有义务公开的信息。该信息于2026年7月1日中欧夏令时14:30，通过下述联系人提交发布。

Contacts for more information:

更多信息的联系方式：

Kerstin Falck, VP Global Corporate Affairs

Kerstin Falck，全球企业事务副总裁

[email protected]

Notes to editors

编者注

About imlifidase

关于伊米立酶

Imlifidase is conditionally approved in the European Union, Norway, Liechtenstein, Iceland and the UK under the tradename Idefirix

伊米立酶在欧盟、挪威、列支敦士登、冰岛和英国以商品名 Idefirix 获得附条件批准。

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.

用于对与可用已故供体交叉配型阳性的致敏成人肾移植患者进行脱敏治疗。Idefirix® 也在澳大利亚和瑞士获得批准。

Information about the trial is available at ClinicalTrials.gov:

试验相关信息可在 ClinicalTrials.gov 网站上查询：

NCT04935177

About Idefirix®

关于 Idefirix®

(imlifidase)

（伊米利酶）

Imlifidase is an antibody-cleaving enzyme originating from

伊米利酶是一种源自

Streptococcus pyogenes

化脓性链球菌

that specifically targets and cleaves immunoglobulin G (IgG) antibodies and inhibits IgG-mediated immune response.

特异性靶向并切割免疫球蛋白G（IgG）抗体，并抑制IgG介导的免疫反应。

It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration.

该药物起效迅速，在给药后数小时内即可裂解IgG抗体并抑制其活性。

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..

伊米利酶在欧洲已获得附条件上市批准，商品名为IDEFIRIX，用于对与可获得的已故供体交叉配型阳性的高度致敏成人肾移植患者进行脱敏治疗。IDEFIRIX的使用应仅限于那些在现有肾脏分配系统（包括针对高度致敏患者的优先分配计划）下不太可能接受移植的患者。

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.

Idefirix 作为欧洲药品管理局（EMA）优先药物（PRIME）计划的一部分接受了审评，该计划旨在支持那些可能较现有疗法具有重大治疗优势或惠及无药可治患者的药物。

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

在欧盟和美国进行的四项II期单臂研究以及在美国进行的一项随机对照III期研究中，评估了imlifidase作为移植前治疗以减少供体特异性IgG抗体的有效性和安全性。

2,3-5

. 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.

Hansa 正在收集更多的临床证据，并将基于上述批准后的疗效研究之外的一项观察性随访研究，提交额外的有效性和安全性数据。

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.

在美国，食品药品监督管理局（FDA）于2026年2月受理了imlifidase的生物制品许可申请（BLA），并将处方药用户费法案（PDUFA）的行动日期定为2026年12月19日。

Full EU product information can be accessed via the initial Summary of Product Characteristics found

完整的欧盟产品信息可通过最初的产品特性概要获取

here

这里

。

About kidney failure

关于肾衰竭

Kidney disease can progress to kidney failure or End-Stage Renal Disease (ESRD), identified when a patient's kidney function is less than 15%.

肾脏疾病可能进展为肾衰竭或终末期肾病（ESRD），当患者的肾功能低于15%时即被诊断为终末期肾病。

ESRD poses a significant health burden, affecting nearly 2.5 million patients worldwide.

终末期肾病（ESRD）带来了巨大的健康负担，全球受影响患者近250万人。

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.

对于合适的终末期肾病（ESRD）患者，肾移植是首选治疗方案，因为它能提高生存率、改善生活质量，并且与长期透析相比更具成本效益。目前，美国和欧洲约有17万名肾病患者正在等待新的肾脏移植。

About Hansa Biopharma

关于汉莎生物制药

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 是一家处于商业化阶段的先锋生物制药公司，致力于开发和商业化新型免疫调节疗法，以变革急性或复杂免疫疾病患者的治疗模式。Hansa 专有的 IgG 裂解酶技术平台旨在满足移植、基因治疗和自身免疫性疾病领域尚未被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).

该公司的产品组合包括imlifidase，这是一种首创的免疫球蛋白G（IgG）抗体切割酶疗法，已证明能使高度致敏患者进行肾移植；还包括HNSA-5487，这是一种下一代IgG切割分子，将针对吉兰-巴雷综合征（GBS）进行开发。

Hansa Biopharma is based in Lund, Sweden, and has operations in Europe and the US 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，业务遍及欧洲和美国。该公司在纳斯达克斯德哥尔摩交易所上市，股票代码为HNSA。更多信息请访问。

www.hansabiopharma.com

and follow us on

并在以下平台关注我们

领英

。

Forward-Looking Statements

前瞻性陈述

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Hansa业务相关的前瞻性陈述，包括但不限于有关Hansa的战略、商业化努力、业务计划、监管申报、临床开发计划、收入和产品销售的预测或预估以及重点的陈述。

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”、“能够”、“会”、“应该”、“预期”、“计划”、“预计”、“打算”、“相信”、“估计”、“预测”、“规划”、“潜在”、“继续”、“目标”及类似表述旨在识别前瞻性陈述，尽管并非所有前瞻性陈述均包含这些识别性词语。

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.

本新闻稿中的任何前瞻性陈述均基于管理层当前的预期和信念，并受多种风险、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任何前瞻性陈述所明示或暗示的内容存在重大差异，包括但不限于与汉萨公司（Hansa）的业务和运营、伊米福酶（imlifidase）的假定作用机制、伊米福酶在上述患者群体或其他潜在适应症中的安全性和有效性、市场对伊米福酶的接受程度、竞争性产品、预期时间表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明示或暗示的任何未来结果、表现或成就存在重大差异的因素。

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 circumstanc.

Hansa提醒您，不要过度依赖任何前瞻性陈述，这些陈述仅在其发表之日有效。Hansa不承担任何义务公开更新或修改此类陈述以反映预期、事件、条件或情况的变化。

References

参考文献

European Medicines Agency. Idefirix® summary of product characteristics. Available at:

欧洲药品管理局。Idefirix® 产品特性概要。可获取于：

https://www.ema.europa.eu/en/documents/product-information/idefirix-epar-product-information_en.pdf

。

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:

Heidt S 等。基于可接受错配原则提供相容器官，使高度致敏患者获益良好。《免疫学前沿》。2021;12:687254。网址：

https://pubmed.ncbi.nlm.nih.gov/34248971/

Jordan SC, et al. IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation.

Jordan SC 等. IgG 内肽酶在高致敏移植患者中的应用。

N Engl J Med

《新英格兰医学杂志》

. 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.

2017年8月3日；377(5):442-453。doi: 10.1056/NEJMoa1612567。勘误见：《新英格兰医学杂志》。2017年10月26日；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.

Winstedt L 等。在一项使用细菌酶 IdeS 的随机剂量递增 I 期研究中完全清除细胞外 IgG 抗体——一种新的治疗机会。《公共科学图书馆·综合》（PLoS One）。2015年7月15日；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.

Lorant T 等。IdeS（imlifidase）降解抗HLA抗体在慢性肾病患者中的安全性、免疫原性、药代动力学和疗效。《美国移植杂志》. 2018年11月;18(11):2752-2762. doi: 10.1111/ajt.14733.

NIH (2018). What is kidney failure? Available at:

美国国立卫生研究院（2018）。什么是肾衰竭？网址：

https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/what-is-kidney-failure

。

Newsletter Transplant 2022. International figures on donation and transplantation. Available at: Newsletter Transplant - latest edition I Freepub (edgm.eu) Accessed: May 2025

《移植通讯》2022年。捐赠与移植的国际数据。获取地址：《移植通讯》最新版 I Freepub (edgm.eu)。访问日期：2025年5月

This information was brought to you by Cision

本信息由 Cision 提供

http://news.cision.com

。

https://news.cision.com/hansa-biopharma-ab/r/hansa-biopharma-announces-closing-of--115-million-licensing-transaction-with-serb-pharmaceuticals-fo,c4369957

The following files are available for download:

以下文件可供下载：

https://mb.cision.com/Main/1219/4369957/4176877.pdf

2026-07-01 Closing Licensing Agreement ENG FINAL

2026-07-01 许可协议结案英文最终版

SOURCE Hansa Biopharma AB

来源：汉莎生物制药公司

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