Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm: HNSA), has announced that the first commercial patient in Australia has received a living donor kidney transplant following treatment with Idefirix® (imlifidase), consistent with the indication approved by the Therapeutic Goods Administration (TGA).
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. Hansa Biopharma AB is a pioneering commercial-stage biopharmaceutical company developing and commercialising novel immunomodulatory therapies to transform care for patients with acute or complex immune disorders.
Patient outcomes will be documented through an established registry in Australia. Data from real-world clinical use will be collected and may contribute to future scientific publications, and help to further the understanding of the use of Idefirix in living donor transplants.
This first commercial living donor transplant patient in Australia represents an important milestone for Hansa and for patients facing significant barriers to transplantation. We look forward to continued collaboration with the Australian transplant community to build experience with Idefirix across both living and deceased donor transplantations.
Renée Aguiar-Lucander, CEO of Hansa Biopharma
Idefirix is approved in Australia as a desensitization treatment of highly sensitized adult kidney transplant candidates who have a positive cross-match against a living or deceased donor.
Highly sensitised patients have pre-formed antibodies called donor specific antibodies (DSAs) with a broad reactivity against human leukocyte antigens (HLAs), which can cause tissue damage and potentially transplant rejection. The presence of DSAs means that highly sensitized patients tend to have limited or no access to transplant, as finding a compatible donor organ can be particularly challenging. The complexity of their immunological profile means that highly sensitized patients spend longer time than average on transplant waiting lists, with evidence showing that this longer time waiting for a suitable donor relates to an increased mortality risk. Across the U.S. and Europe, highly sensitized patients comprise around 10-15% of the total of patients on transplant waiting lists.
Imlifidase is conditionally approved in the European Union, Norway, Liechtenstein, Iceland and the UK under the tradename Idefirix® for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive cross-match against an available deceased donor. Idefirix® is also approved in Australia, Israel and Switzerland.
Kidney disease can progress to kidney failure or End-Stage Renal Disease (ESRD), identified when a patient’s kidney function is less than 15%. ESRD poses a significant health burden, affecting nearly 2.5 million patients worldwide. 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 U.S. and Europe waiting for a new kidney.
Hansa’s proprietary IgG-cleaving enzyme technology platform addresses serious unmet medical needs in transplantation, gene therapy and autoimmune diseases. 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).
Hansa Biopharma won the 2025 SwedenBIO Award for its contribution to Swedish life science.
In picture: Hansa Biopharma team at the award ceremony https://www.linkedin.com/company/hansa-medical-ab/
