Our Commitment

“At Hansa Biopharma we envision a world where patients with rare immunologic diseases can lead long and healthy lives.

We are dedicated to attaining market approval for the first treatment that potentially may enable kidney transplantation in highly sensitized patients.”

 

Søren Tulstrup President and CEO of Hansa Biopharma

Our Vision

A world where all patients with rare immunologic diseases can lead long and healthy lives.

Our Mission

We leverage our unique enzyme technology platform to develop innovative, lifesaving and life altering immunomodulating therapies, bring these to the patients with rare diseases who need them, and generate value to society at large.

 

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Our goal is to create value for patients, healthcare providers, societies and our shareholders. We are striving to develop therapies for patients with an unmet medical need and bringing our drugs all the way from the laboratory to the patients.

Recent Achievements

Hansa Biopharma has applied for marketing authorization of imlifidase for enabling kidney transplantation in highly sensitized patients in the EU. The Marketing Authorization Application is currently under review by the European Medicines Agency. We are in dialogue with the U.S. Food and Drug Administration to pursue a regulatory path forward.

We have initiated three Phase 2 clinical studies in autoimmune indications; Guillain-Barré Syndrome (GBS), Goodpasture’s syndrome (anti-GBM antibody disease) and acute Antibody-Mediated Rejection (AMR) in kidney transplantation.

We have selected a lead candidate in the NiceR program and are exploring the opportunities for repeat dosing in a range of conditions including relapsing autoimmune diseases, chronic transplant rejection, pre-treatment in oncology and in combination with gene therapy.

Strategic Priorities

Attain marketing authorization for our antibody-cleaving enzyme imlifidase as a treatment for highly sensitized patients prior to kidney transplantation

Establish a commercial and medical infrastructure in Europe and the U.S.

Investigate the potential of imlifidase in additional transplant areas and in autoimmune indications

Advance the next generation of immunomodulatory enzymes, designed for repeat dosing, into clinical development

Explore potential combination therapies in oncology with IgG-modulating enzymes and gene therapy in patients with neutralizing antibodies