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Hansa Biopharma
HNSA (, %) SEK
Hansa Biopharma
Purple colonies of streptococcus bacteria

History

A story of innovation

Discovery

2001-2010

The enzyme IdeS is discovered at Lund University in Streptococcus pyogenes bacteria. The enzyme appears to have the unique ability to neutralize antibodies. The genetic code for the enzyme is then transferred from Streptococcus pyogenes, into E.coli bacteria through recombinant DNA technology, allowing for its production and isolation.

In 2007, the company is founded with the name Hansa Medical and listed Nasdaq First North Growth Market Stockholm from 2007 to 2015 and on the Nasdaq Stockholm since 2015. The clinical development process is outlined, initially focusing on kidney transplantation for highly sensitized patients. In 2008, Project HMedIdeS (imlifidase) is initiated.

 Development

2013-2019

Hansa runs the first successful in-human study of imlifidase in 2013. Starting in 2014, the company runs and completes four Phase 2 studies enabling kidney transplantation in 46 patients. 

In 2014 Hansa initiates Phase 2 studies in Anti-GBM Antibody disease, Antibody mediated kidney transplant rejection (AMR) and Guillain-Barré syndrome (GBS).

In 2017, imlifidase is granted orphan drug designation by the European Commission, followed by the US Food and Drug Administration (FDA) in 2018.

In 2019, on the back of the Phase 2 studies, a marketing authorization application is submitted to the European Medicines Agency (EMA) for the use of imlifidase in kidney transplantation.

Expansion

2020 - present

In June 2020, Hansa enters into the expanding space of gene therapy through a partnership agreement with Sarepta Therapeutics. Further partnerships established in 2021 with argenx BV and in 2022 with AskBio support the expansion in new indications and disease areas.

In August 2020, Hansa's first product in kidney transplantation is granted conditional authorization by the European Medicines Agency (EMA).

While overseeing significant growth in the number of its employees and in its international presence, Hansa Biopharma AB is certified as a Great Place to Work® for two consecutive years, in 2020 and 2021.