Hansa Biopharma AB, today announced that its Biologics License Application (BLA) for imlifidase has been accepted by the U.S. Food and Drug Administration (FDA).

Hansa Biopharma AB今天宣布，其针对imlifidase的生物制品许可申请（BLA）已被美国食品药品监督管理局（FDA）接受。

FDA's filing review was completed on day 60 which is meant to verify that the submission is substantially complete and meets the requirements for a full evaluation.

FDA的文件审查在第60天完成，这是为了核实提交的文件基本完整并符合全面评估的要求。

Renée Aguiar-Lucander, CEO, Hansa Biopharma said: “We now look forward to receiving the 74-Day Letter which will provide details regarding review plan, timelines and other pertinent information and start working with the FDA as they go through their review over the coming months.”

汉莎生物制药公司首席执行官雷内·阿吉亚尔-卢坎德表示：“我们期待收到74天函件，其中将提供有关审评计划、时间表和其他相关信息的细节，并在接下来的几个月中开始与FDA合作进行审评。”

Imlifidase is a unique IgG‑cleaving enzyme that rapidly inactivates > 95% of donor‑specific antibodies within 2–6 hours of administration, providing a crucial window to enable HLA‑incompatible kidney transplantation.

Imlifidase 是一种独特的 IgG 切割酶，可在给药后 2 至 6 小时内迅速使超过 95% 的供体特异性抗体失活，为实现 HLA 不相容的肾移植提供了关键窗口。

The BLA submission for imlifidase is supported by the previously communicated highly statistically significant outcome of the pivotal U.S. Phase 3 ConfIdeS trial, which evaluated 12-month kidney function in highly sensitized adult kidney transplant patients (cPRA ≥99.9%) with a positive crossmatch against a deceased donor, compared to a control arm.

imlifidase的BLA提交得到了此前公布的关键性美国III期ConfIdeS试验结果的支持，该试验评估了高致敏成人肾移植患者（cPRA≥99.9%）在与已故供体交叉配型呈阳性的情况下12个月的肾功能，对照组为对照臂。

The trial successfully met its primary endpoint, demonstrating significantly improved kidney function in the imlifidase arm at 12 months as measured by mean estimated glomerular filtration rate (eGFR) (p < 0.0001). A key secondary endpoint—dialysis independence at 12 months—was also statistically significant in favor of imlifidase (p = 0.0007).

试验成功达到了主要终点，结果显示在 12 个月时，imlifidase 组的肾功能显著改善，以平均估算肾小球滤过率 (eGFR) 衡量 (p < 0.0001)。一个关键的次要终点——12 个月时无需透析——也显示出对 imlifidase 具有统计学意义的优势 (p = 0.0007)。

Imlifidase was generally well tolerated, with a safety profile consistent with previous clinical trial experience. .

Imlifidase 通常耐受性良好，其安全性与之前的临床试验经验一致。

About ConfIdeS

关于ConfIdeS

ConfIdeS is a pivotal Phase 3 open label, randomized, controlled trial of imlifidase in kidney transplantation. The trial evaluated kidney function at 12 months in 64 highly sensitized (cPRA ≥99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with a control arm.

ConfIdeS 是一项关键的 III 期开放标签、随机、对照试验，评估了 imlifidase 在肾移植中的应用。该试验在 64 名高度致敏（cPRA ≥99.9%）且针对 deceased donor 呈阳性交叉配型的肾移植患者中，比较了使用 imlifidase 进行脱敏与对照组的效果，并在 12 个月时评估了肾功能。

A total of 25 U.S. sites participated in the trial, and the primary endpoint was kidney graft function at 12 months, measured by mean eGFR (estimated glomerular filtration rate). The total trial duration is five years, which includes a long-term follow-up agreed with the FDA as part of the accelerated approval pathway.

共有 25 个美国试验点参与了这项试验，主要终点是通过平均 eGFR（估算肾小球滤过率）测量的 12 个月时的肾脏移植物功能。试验总时长为五年，其中包括作为加速批准途径的一部分而与 FDA 达成共识的长期随访。

About imlifidase

关于 imlifidase

Imlifidase is conditionally approved in the European Union, Norway, Lichtenstein, 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..

Imlifidase 在欧盟、挪威、列支敦士登、冰岛和英国获得附条件批准，商标名为 IDEFIRIX®，用于对高致敏成人肾移植患者进行脱敏治疗，这些患者对可用的已故供体呈阳性交叉配型。IDEFIRIX® 也已在澳大利亚和瑞士获得批准。

Information about the trial is available at ClinicalTrials.gov: NCT04935177

有关该试验的信息可在 ClinicalTrials.gov 查阅：NCT04935177

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 19:53 CET on February 18, 2026.

这是Hansa Biopharma AB（publ）根据欧盟市场滥用条例规定必须公开的信息。该信息通过以下列出的联系人提交发布，时间为2026年2月18日欧洲中部时间19:53。

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

IR@hansabiopharma.com

IR@hansabiopharma.com

Kerstin Falck, VP Global Corporate Affairs

克尔斯廷·法尔克，全球企业事务副总裁

media@hansabiopharma.com

媒体@汉萨生物制药.com

kerstin.falck@hansabiopharma.com

kerstin.falck@hansabiopharma.com

About IDEFIRIX® (imlifidase)

关于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是一种源自化脓性链球菌的抗体切割酶，专门靶向并切割免疫球蛋白G（IgG）抗体，抑制IgG介导的免疫反应。它起效迅速，在给药后数小时内即可切割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.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.

Imlifidase 在欧洲获得附条件上市许可，并以商品名 IDEFIRIX 上市，用于对具有阳性交叉配型的高度致敏成年肾移植患者进行脱敏治疗。IDEFIRIX 的使用应保留给那些在现有肾脏分配系统（包括针对高度致敏患者的优先计划）下不太可能接受移植的患者。IDEFIRIX 作为欧洲药品管理局 (EMA) 的 PRIority Medicines (PRIME) 计划的一部分接受了审查，该计划支持可能较现有治疗方法具有重大治疗优势或使无治疗选择的患者受益的药物。

The efficacy and safety of imlifidase as a pre-transplant treatment to reduce donor-specific IgG was studied in four Phase 2 open-label, single-arm, six-month clinical trials.2,3-5 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..

在四项二期开放标签、单臂、六个月的临床试验中研究了 imlifidase 作为移植前治疗以减少供体特异性 IgG 的有效性和安全性。Hansa 正在收集更多的临床证据，并将基于一项观察性随访研究和一项批准后的有效性研究提交额外的有效性和安全性数据。

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

完整的欧盟产品信息可以通过此处的初始产品特性摘要访问。

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%.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.

肾病可进展为肾衰竭或终末期肾病 (ESRD)，当患者的肾功能低于 15% 时即可诊断为ESRD。ESRD 带来了显著的健康负担，影响着全球近 250 万名患者。对于适合进行移植的 ESRD 患者，肾移植是首选治疗方案，因为它可以提高生存率和生活质量，并且与长期透析相比节省了成本。

There are approximately 170,000 kidney patients in the US and Europe waiting for a new kidney.7.

美国和欧洲大约有 17 万名肾病患者在等待新的肾源。

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 to address 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，致力于开发和推广新型免疫调节疗法，以改变急性或复杂免疫疾病患者的治疗方式。Hansa 专有的 IgG 切割酶技术平台旨在满足移植、基因治疗和自身免疫疾病领域中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).

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，已被证明能够使高度致敏患者接受肾移植；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  www.hansabiopharma.com  and follow us on LinkedIn..

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。更多信息请访问www.hansabiopharma.com，并在LinkedIn上关注我们。

©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 汉莎生物制药公司。汉莎生物制药、灯塔标志、IDEFIRIX 和 IDEFIRIX 花形标志是瑞典隆德汉莎生物制药公司的商标。保留所有权利。

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声明，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声明。

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”、“可能”、“会”、“应该”、“预期”、“计划”、“预期”、“打算”、“相信”、“估计”、“预测”、“项目”、“潜力”、“继续”、“目标”等类似表述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.

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 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.

汉莎航空提醒您，不要过分依赖任何前瞻性声明，这些声明仅在其发布之日有效。汉莎航空不承担任何义务公开更新或修改任何此类声明，以反映预期、事件、条件或情况的任何变化。

References

参考文献

Source: hansabiopharma.com

来源：hansabiopharma.com