Breakthrough in Kidney Transplantation: Hansa Biopharma and SERB Pharmaceuticals Secure €115M Deal for IDEFIRIX® in Europe and MENA

A landmark licensing agreement between Hansa Biopharma and SERB Pharmaceuticals will bring IDEFIRIX® (imlifidase), a first-in-class treatment for highly sensitized kidney transplant patients, to Europe and the Middle East and North Africa (MENA) region. The €115 million deal—announced May 19, 2026—marks a pivotal step forward for patients facing one of the most challenging barriers in transplantation: antibody-mediated rejection.

— ### Why This Deal Matters: Addressing a Critical Unmet Need Kidney transplantation is life-saving, yet approximately 20–30% of potential recipients are highly sensitized—meaning their immune systems have developed antibodies against potential donor organs, making transplantation nearly impossible without desensitization. IDEFIRIX®, conditionally authorized by the European Commission in 2025, offers a rapid solution by cleaving all classes of immunoglobulin G (IgG) antibodies within 2 to 6 hours. This breakthrough eliminates the need for prolonged plasmapheresis or intravenous immunoglobulin (IVIG) therapies, which carry significant risks and limited efficacy. > “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.” > — Renée Aguiar-Lucander, CEO of Hansa Biopharma > Source — ### Key Details of the Licensing Agreement The partnership grants SERB Pharmaceuticals exclusive rights to develop and commercialize IDEFIRIX® across: – European Union (EU) – United Kingdom (UK) – Switzerland, Norway, Liechtenstein, Iceland – Middle East and North Africa (MENA) region #### Financial and Strategic Implications 1. €115 Million Upfront Payment The agreement includes a significant upfront payment, strengthening Hansa Biopharma’s financial position to accelerate its U.S. Launch, expected in late 2026 pending FDA approval. This deal also ensures a clearer path to profitability for the company. 2. SERB’s Commercial Expertise SERB brings a proven track record in critical care and rare disease commercialization, including experience with complex therapies. Their established presence in Europe positions IDEFIRIX® for rapid adoption in transplant centers across the region. 3. Global Expansion Strategy While the deal focuses on Europe and MENA, Hansa Biopharma retains rights for other markets, including the U.S. And Asia. The company’s pipeline continues to advance, with two additional clinical-stage programs targeting autoimmune and inflammatory diseases. — ### How IDEFIRIX® Works: A Scientific Breakthrough IDEFIRIX® (imlifidase) is the first and only enzyme designed to specifically degrade all IgG subclasses, including IgG1, IgG2, IgG3, and IgG4. Traditional desensitization methods—such as plasmapheresis or IVIG—require multiple sessions and carry risks like infections or fluid overload. IDEFIRIX®’s mechanism of action offers: – Rapid antibody depletion (within hours) – Reduced treatment duration (compared to weeks of plasmapheresis) – Potential for outpatient administration, improving patient quality of life > “IDEFIRIX offers a pioneering breakthrough for patients with a significant unmet medical need.” > — Hansa Biopharma Press Release — ### Impact on Patients and Healthcare Systems #### For Transplant Candidates – Expanded eligibility: Highly sensitized patients (those with panel-reactive antibody levels >80%) now have a viable option for desensitization. – Faster access to transplantation: Clinical trials have shown IDEFIRIX® enables transplantation within 14 days of treatment in many cases, compared to months or years with conventional methods. #### For Hospitals and Health Systems – Cost savings: Reducing the need for prolonged IVIG or plasmapheresis sessions lowers overall treatment costs. – Streamlined workflows: Single-dose administration simplifies logistical challenges in transplant centers. #### Regulatory Milestones – Conditional EU Approval (2025): Granted under the European Medicines Agency’s (EMA) conditional approval pathway, allowing earlier access for unmet needs. – Pending U.S. FDA Review: Hansa Biopharma is targeting a 2026 approval, which would further expand IDEFIRIX®’s reach. — ### FAQ: What Patients and Providers Need to Know