Hansa Biopharma AB (publ)

Hansa Biopharma is a commercial-stage biopharmaceutical company based in Lund, Sweden, focused on developing and commercializing innovative immunomodulatory treatments for individuals with rare immunological conditions. The company's mission is to leverage its expertise in enzyme technology and immunology to transform care for patients suffering from acute or complex immune disorders.

The company's core technology revolves around a proprietary antibody-cleaving enzyme platform designed to eliminate pathogenic IgG antibodies. Its lead product, Idefirix (imlifidase), is a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy approved in the European Union for desensitization treatment in highly sensitized adult kidney transplant patients. Hansa Biopharma's pipeline also includes HNSA-5487, a next-generation IgG-cleaving enzyme under development for Guillain-Barré Syndrome (GBS) and other neuro-autoimmune conditions. The company's therapeutic focus areas include transplantation, autoimmune diseases, and gene therapy.

Recent developments include the appointment of Renée Aguiar-Lucander as CEO in April 2025, followed by other key executive appointments to strengthen the leadership team. In December 2025, Hansa Biopharma submitted a Biologics License Application (BLA) for imlifidase to the FDA for highly sensitized kidney transplant patients, following positive Phase 3 trial results, with a PDUFA target date set for December 19. To support its strategic initiatives, including a potential U.S. launch of imlifidase, the company secured a USD 30 million convertible note financing in March 2026. Hansa Biopharma also announced plans for a restructuring in May 2025 to optimize resources and operational efficiency.