Hansa Biopharma AB (publ) is a clinical‐stage biopharmaceutical company headquartered in Lund, Sweden, focused on the development and commercialization of precision immunomodulatory therapies for rare diseases. The company’s proprietary platform centers on highly specific bacterial enzymes that selectively cleave immunoglobulin G (IgG) antibodies, offering a novel approach to desensitization and immunomodulation in transplant and autoimmune settings.
The lead asset, imlifidase (Idefirix), is an enzyme therapeutic designed to rapidly inactivate donor‐specific antibodies in highly sensitized kidney transplant patients. Idefirix has received marketing authorization in the European Union for desensitization of adult patients with chronic kidney disease who are incompatible with potential kidney donors due to preformed anti‐HLA antibodies, and the U.S. Food and Drug Administration is reviewing a Biologics License Application. In addition to transplant indications, Hansa is advancing early‐stage programs exploring its enzyme technology in immuno‐oncology and rare autoimmune disorders.
Founded in 2003, Hansa Biopharma operates from its corporate headquarters in Lund with a U.S. subsidiary in Boston to support North American development and commercialization efforts. The company collaborates with leading transplant centers and academic institutions across Europe and the United States, leveraging clinical partnerships to drive patient access and gather real‐world evidence. Its multidisciplinary team combines expertise in enzymology, immunology, and clinical development to propel its pipeline candidates through late‐stage studies.
Under the leadership of a seasoned executive management team and guided by an experienced board of directors, Hansa Biopharma is preparing for the commercial launch of Idefirix in multiple territories while advancing next-generation enzyme candidates. The company’s strategic priorities include expanding approved indications, securing regulatory approvals in key markets, and forging partnerships to extend the impact of its enzyme platform in immunological disease areas with high unmet medical need.
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