Skip to main contentSkip to navigationSkip to search
HNSA (, %) SEK
Hansa Biopharma logotype
EN,SE

Our Product

Imlifidase

Imlifidase is a unique antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets IgG and inhibits IgG-mediated immune response.

Using imlifidase is a novel approach to eliminate pathogenic IgG. It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their reactivity within hours after administration.

Hansa is leveraging its enzyme technology platform to develop immunomodulating treatments for rare IgG-mediated autoimmune conditions, transplant rejection and cancer.

The Research and Development program is advancing the unique enzyme technology to develop the next generation IgG-cleaving enzymes with lower immunogenicity, for repeat dosing. Imlifidase has a strong patent portfolio offering protection beyond 2035.

Potential for Imlifidase

Christian Kjellman
SVP, Chief Scientific Officer and Chief Operating Officer

Regulatory Status 

The European Commission has conditionally approved Idefirix (imlifidase) for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.

Hansa Biopharma has reached an agreement with the FDA on a regulatory path forward for imlifidase in kidney transplantation of highly sensitized patients. Upon an agreement with the FDA, and following submission of a final study protocol, the Company will conduct a randomized, controlled clinical study in a limited group of highly sensitized kidney patients using kidney function (eGFR) as surrogate endpoint.

Hansa’s research and development program is also advancing the Company’s enzyme technology to develop the next generation of IgG-cleaving enzymes with potentially lower immunogenicity, suitable for repeat dosing in relapsing autoimmune diseases and oncology.