Hansa Biopharma Signs €115 Million Imlifidase Licensing Agreement with SERB

Sweden-based biopharmaceutical company Hansa Biopharma (Hansa) and SERB Pharmaceuticals (SERB), a European-based specialty pharma company, have entered into an exclusive licensing agreement valued at €115 million (US$134 million) for development and commercialization of imlifidase (Idefirix), an immunoglobulin G (IgG)-cleaving enzyme, across Europe and the Middle East and North Africa (MENA) region.¹

The agreement covers the European Union, United Kingdom, Switzerland, Norway, Liechtenstein, Iceland, and MENA territories. Under the deal, Hansa will receive an upfront payment of €110 million (US$128 million) and an additional €5 million (US$6 million) payment upon acceptance of a filing seeking full approval of imlifidase by the European Medicines Agency (EMA). Completion of the agreement remains subject to customary closing conditions, including foreign direct investment regulatory approval, and is expected within 60 days.

“This agreement is transformative for Hansa Biopharma,” said Renée Aguiar-Lucander, CEO of Hansa Biopharma, in a company press releae.¹ “It crystallizes the value of the franchise and significantly strengthens our financial position assuring an optimized US launch and a pathway to profitability, subject to a 2026 US approval, as well as the continued pursuit of our R&D pipeline.”

How will SERB support commercialization of imlifidase?

Under the agreement, SERB will assume responsibility for development and commercialization activities for imlifidase in transplantation across the licensed territories. Hansa will support SERB during the EMA filing and review process following reporting of topline data from a post-authorization efficacy study (PAES).

SERB will later assume responsibility for long-term PAES follow-up and an ongoing pediatric study after obtaining market authorization holder status. The company’s commercial infrastructure and rare disease experience offer the capability to expand access to the therapy in transplantation settings.

“SERB is committed to expanding access to transplantation for highly sensitized patients who currently have very limited alternatives,” said Jeremie Urbain, chairman of SERB, in the release.¹ “SERB is designed to address rare and urgent conditions, and will leverage its … expertise, … commercial execution, and established platform across Europe and MENA to expand the reach and clinical impact of [Idefirix].”

What clinical role does imlifidase play in kidney transplantation?

Imlifidase is derived from Streptococcus pyogenes. It rapidly cleaves IgG antibodies and suppresses IgG-mediated immune responses within hours after administration.²

The therapy is intended for highly sensitized adult kidney transplant patients who are unlikely to receive transplantation under available allocation systems due to pre-existing donor-specific antibodies.² According to Hansa, imlifidase enables desensitization prior to transplantation in patients with positive crossmatch tests against available deceased donors.

The therapy received conditional marketing authorization in Europe and has also been approved in Australia and Switzerland. It was evaluated through four phase 2 single-arm studies in Europe and the United States, along with a randomized phase 3 trial in the US.

How does the agreement support Hansa’s broader regulatory strategy?

The transaction provides financial flexibility to support Hansa’s ongoing commercialization and development activities, including its US regulatory strategy for imlifidase.

In February 2026, FDA accepted the biologics license application for imlifidase and assigned a Prescription Drug User Fee Act action date of Dec.19, 2026, according to Hansa.¹ The company is also continuing development of additional immunomodulatory therapies targeting transplantation, autoimmune disease, and gene therapy applications.

Kidney failure, or end-stage renal disease, affects approximately 2.5 million patients worldwide.³ Hansa estimated that approximately 170,000 patients in the US and Europe are currently waiting for kidney transplantation.¹

References

1. Hansa Biopharma. Hansa Biopharma enters into €115 million licensing agreement with SERB Pharmaceuticals for IDEFIRIX in Europe and MENA. Published May 19, 2026. Accessed May 19, 2026. https://www.hansabiopharma.com/media/press-releases/2026/hansa-biopharma-enters-into-115-million-licensing-agreement-with-serb-pharmaceuticals-for-idefirix-in-europe-and-mena/
2. EMA. Idefirix summary of product characteristics. Accessed May 19, 2026. https://www.ema.europa.eu/en/documents/product-information/idefirix-epar-product-information_en.pdf
3. NIH. What is kidney failure? Accessed May 19, 2026. https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/what-is-kidney-failure