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Our Equity Story
A unique immunomodulatory enzyme technology
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
Evolution into a fully integrated biopharmaceutical company
Controlling the full value chain from early discovery through commercialization to maximize the value creation and capture
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.
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.