Our Equity Story

A unique immunomodulatory enzyme technology

Imlifidase works

Targeting rare diseases with a high unmet medical need

  • Imlifidase is a unique IgG antibody-cleaving enzyme with a rapid onset of action and high specificity for inactivation of IgG​ in patients with rare immunologic diseases
Well positioned for commercial success

Evolution into a fully integrated biopharmaceutical company

  • Controlling the full value chain from early discovery through commercialization to maximize the value creation and capture
Addresses a clear unmet need

Preparing for commercialization

  • The European Commission has granted conditional approval for imlifidase in highly sensitized kidney transplant patients in the European Union.
  • Imlifidase to be launched through Hansa´s own medical and commercial organization, while we expected to pursue a partnership strategy outside core markets.
  • In the US, a randomized controlled trial is planned to be initiated in H1 2021, which could support a future BLA submission in the US by 2023. The study protocol was submitted to the FDA June 2020.
  • Broad technology protection with patent coverage throughout 2035 in key markets and orphan drug designation in both the US/EU in our lead indications.
Rich pipeline

Leveraging our proprietary antibody cleaving enzyme technology

  • Advancing our pipeline with three phase 2 programs in transplantation and acute autoimmune diseases.
  • New set of modified enzymes under development (NiceR program) for repeat dosing; potentially enabling treatment in relapsing diseases and oncology.
  • Exploring potential combination therapies in oncology with IgG-modulating enzymes and gene therapy in patients with neutralizing antibodies through potential partnerships.