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

  • Preparing for potential launch of imlifidase under conditional approval in core European markets starting in H2 2020. MAA is currently under review by EMA
  • Imlifidase to be launched through Hansa´s own medical and commercial organization, while the company is expected to pursue a partnership strategy outside core markets
  • In the US a clear regulatory path has been agreed with the FDA that support potential submission of a BLA in 2023 under the accelerated approval pathway
  • 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 partnerships