Hansa Biopharma
Hansa Biopharma is a Swedish commercial-stage biopharmaceutical company developing IgG-cleaving enzyme therapies, most notably IDEFIRIX (imlifidase), which enables kidney transplantation in highly sensitized patients and is pending FDA approval for U.S. launch.
- Company typePublic
- Founded2012
- HeadquartersLund, Sweden
- Headcount101–250
- GTM typeB2B
- OfferingHardware or Manufacturing
What Hansa Biopharma does
Hansa Biopharma AB is a commercial-stage biopharmaceutical company headquartered in Lund, Sweden, and listed on Nasdaq Stockholm under the ticker HNSA. The company develops immunomodulating therapies based on a proprietary IgG-cleaving enzyme platform derived from Streptococcus pyogenes, designed to inactivate immunoglobulin G antibodies and enable transplantation, gene therapy, and treatment of IgG-driven autoimmune diseases.
Its commercial product IDEFIRIX (imlifidase) is a first-in-class IgG-cleaving enzyme conditionally approved across Europe, the UK, Australia, Israel, and Switzerland for desensitization of highly sensitized adult kidney transplant patients, a population representing roughly 10-15% of transplant waiting lists. A U.S. Biologics License Application has been accepted with a PDUFA action date of December 19, 2026. A next-generation candidate, HNSA-5487, is being developed for Guillain-Barré syndrome with FDA interactions planned for H1 2026.
Hansa generates revenue from direct IDEFIRIX product sales through hospital and transplant center channels across 24 European countries, supplemented by out-licensing (notably a €115M deal with SERB Pharmaceuticals for EU/UK/MENA rights in May 2026) and non-dilutive financing instruments such as the $70M NovaQuest agreement and $30M Athyrium convertible note. The company's primary customers are transplant centers and rare-disease patients, with ongoing gene therapy collaborations with Genethon and Sarepta expanding into adjacent indications.
Hansa Biopharma firmographics
Firmographics- Name
- Hansa Biopharma
- Legal name
- Hansa Biopharma AB
- Website
- https://hansabiopharma.com
- Company type
- Public
- Founded year
- 2012
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- Hansa Biopharma is a Swedish commercial-stage biopharmaceutical company developing IgG-cleaving enzyme therapies, most notably IDEFIRIX (imlifidase), which enables kidney transplantation in highly sensitized patients and is pending FDA approval for U.S. launch.
- Ownership category
- akta.pro rank
Hansa Biopharma industry classification
Industry- Product category
- Biopharmaceuticals / Rare Disease Therapeutics
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254)
- SIC
- Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)
- akta.pro primary industry
- Transplant & Immunosuppression Specialty Pharmaceuticals (HLAIACAJ)
- akta.pro secondary industries
- Immunology & Inflammation Pharmaceuticals (HLAIAAAD), Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB), Rare Immunology, Autoimmune & Autoinflammatory Therapies (HLAIAIAE)
Keywords
Where Hansa Biopharma is headquartered
LocationHeadquarters
- HQ city
- Lund
- HQ country
- Sweden
- HQ region
- Europe
Offices1 record
Markets served
Hansa Biopharma business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Technology or R&D, Marketing or Sales, Operations
Revenue model
- Product Sales - IDEFIRIX: Commercial product revenue from IDEFIRIX sales in European markets. 46% growth in European product revenue in 2025. Coverage in 24 countries.
- Out-licensing - SERB Pharmaceuticals: Exclusive development and commercialization rights to Idefirix for EU, UK, Switzerland, Norway, Iceland, MENA region. €110 million upfront + €5 million upon EMA acceptance of filing for full approval.
- Non-dilutive Financing - NovaQuest: $70 million non-dilutive financing with milestone and royalty payments based on future sales and approvals for enzyme technology development.
Go-to-market motion2 records
Distribution channels3 records
Marketing channels5 records
Hansa Biopharma product offering
Product offeringCore offering
Hansa Biopharma develops and commercializes immunomodulatory biopharmaceutical products based on its proprietary IgG-cleaving enzyme platform. Its lead commercial product, IDEFIRIX (imlifidase), is a first-in-class bacterial enzyme therapy conditionally approved in the EU, UK, Australia, Israel, and Switzerland for desensitization of highly sensitized adult kidney transplant patients. The company is preparing for U.S. market entry pending FDA approval (PDUFA December 19, 2026), and is advancing a next-generation enzyme, HNSA-5487, for Guillain-Barré syndrome.
Product overview
Hansa Biopharma is a commercial-stage biopharmaceutical company developing immunomodulating therapies based on its proprietary IgG-cleaving enzyme platform. The company's portfolio consists of two main products: Idefirix (imlifidase), a first-in-class enzyme therapy conditionally approved in Europe and under FDA review in the US for enabling kidney transplantation in highly sensitized patients; and HNSA-5487, a next-generation IgG-cleaving enzyme in development for Guillain-Barré syndrome. The company's technology platform targets IgG antibodies to inhibit harmful immune responses in transplantation, gene therapy, and autoimmune diseases.
Differentiator
Problem solved
Functional benefit
Brands
- IDEFIRIX: The brand name for imlifidase in Europe and approved markets (EU, Norway, Liechtenstein, Iceland, UK, Australia, Israel, Switzerland). It is a first-in-class IgG-cleaving enzyme therapy for desensitizing highly sensitized kidney transplant patients.
- IDEFIRIX flower logo
Products and services
- Idefirix (imlifidase) A first-in-class IgG-cleaving enzyme derived from Streptococcus pyogenes that enables HLA-incompatible kidney transplantation by rapidly inactivating donor-specific IgG antibodies. Conditionally approved in EU, Norway, Liechtenstein, Iceland, UK, Australia, Israel, and Switzerland for desensitization of highly sensitized adult kidney transplant patients awaiting deceased donor transplantation. FDA BLA under review (PDUFA December 19, 2026).
- HNSA-5487 Next-generation IgG-cleaving enzyme molecule being developed for Guillain-Barré syndrome (GBS), a rare autoimmune disease causing severe pain and potential paralysis. Pre-clinical/early-stage development with FDA interactions planned for H1 2026.
Companies that use Hansa Biopharma
Customer profileNamed customers2 records
Segments2 records
Ideal customer profiles2 records
Hansa Biopharma technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature2 records
Hansa Biopharma partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered core and minor.
- SERB PharmaceuticalscoreSERB Pharmaceuticals acquired exclusive development and commercialization rights to Idefirix for €115 million covering EU, UK, Switzerland, Norway, Iceland, Liechtenstein, and MENA region. Hansa receives €110 million upfront and €5 million upon EMA acceptance of filing for full approval. Transaction subject to FDI regulatory approval expected within 60 days.
- GenethoncoreCollaboration to enable gene therapy treatment in patients with Crigler-Najjar syndrome who have pre-formed antibodies against AAV vectors. First patient successfully treated following imlifidase pre-treatment. GNT-018-IDES clinical trial demonstrated feasibility and safety.
- SareptaminorPartnership to advance use of imlifidase enzyme as per-treatment to Sarepta's approved medication for Duchenne Muscular Dystrophy (DMD), enabling treatment in patients with pre-formed antibodies against AAV vectors.
- EurotransplantcoreEurotransplant initiated Desensitization Program - first international allocation system utilizing imlifidase to enable kidney transplantation in highly sensitized patients. AM program has helped 1,700+ highly sensitized patients receive transplants. Desensitization Program identified 173 patients waiting 5+ years.
Scale indicators6 records
Recent moves6 records
Expansion highlights6 records
Hansa Biopharma competitors and assessment
Company assessmentEmerging players
- argenx: Commercial-stage immunology biopharmaceutical company focused on antibody-mediated autoimmune diseases using Fc receptor-targeting technologies. Comparable as a developer of innovative IgG-targeting biologics for rare immunological conditions with a similar commercial-stage profile and specialty rare-disease focus.
- Alnylam Pharmaceuticals: Commercial-stage biopharmaceutical company developing RNA interference therapeutics for rare diseases, including genetic conditions affecting the liver. Comparable as a developer of innovative therapies for rare diseases with similar commercial-stage profile, capital intensity, and focus on addressing underserved patient populations.
- Sarepta Therapeutics: Commercial-stage gene therapy company for Duchenne Muscular Dystrophy and other rare genetic conditions. Comparable as both a partner (Hansa's imlifidase enables Sarepta's AAV gene therapy in seropositive patients) and a peer in developing innovative biologics for rare diseases with similar hospital-channel commercialization.
Broad incumbents
- Astellas Pharma: Large Japanese pharmaceutical company with a major transplant franchise including Prograf (tacrolimus) for immunosuppression in organ transplantation. Comparable as an established player in the transplant therapeutics market where Hansa also operates with IDEFIRIX.
- Bristol Myers Squibb: Large pharmaceutical company with Nulojix (belatacept) for kidney transplant immunosuppression and broader immunology portfolio. Comparable as a major incumbent in transplant therapeutics with overlapping indications and a hospital-channel sales motion targeting transplant centers.
- Sanofi: Large global pharmaceutical company with Thymoglobulin (anti-thymocyte globulin) used in transplant immunosuppression and a broader immunology franchise including Dupixent. Comparable as a broad incumbent with transplant and immunology assets, leveraging established hospital sales infrastructure.
- Vertex Pharmaceuticals: Large biopharmaceutical company developing therapies for serious rare diseases including cystic fibrosis and sickle cell disease. Comparable as a commercially successful rare-disease specialty biopharma with similar business model of innovative therapies for underserved populations and hospital-based specialty distribution.
Direct peers
- Veloxis Pharmaceuticals: Specialty pharmaceutical company focused exclusively on transplant therapeutics, developing immunosuppression therapies for organ transplant patients. Most directly comparable peer as both companies target the transplant market with specialty pharmaceuticals serving transplant centers and patients.
- CareDx: Commercial-stage company providing transplant diagnostics and patient management solutions to transplant centers, with established hospital sales channels in kidney transplantation. Comparable business model serving transplant centers, with similar customer base (highly sensitized patients and transplant programs) and revenue growth profile.
Others
- Bio-Rad Laboratories: Life science company providing antibody testing reagents and platforms used in donor-specific antibody screening for transplantation. Adjacent comparable as an enabling technology provider whose Luminex-based antibody detection systems are used to identify the highly sensitized patient population Hansa serves.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Hansa Biopharma social profiles
Digital presenceHansa Biopharma financial estimates
Financial estimateRevenue estimate
Valuation estimate
Hansa Biopharma leadership team
Management profileNumber of profiles
Profiles13 records
Hansa Biopharma funding detail
Funding detailFunding overview
Funding rounds4 records
Investors8 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Hansa Biopharma M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Hansa Biopharma
What does Hansa Biopharma do?
Hansa Biopharma develops and commercializes immunomodulatory biopharmaceutical products based on its proprietary IgG-cleaving enzyme platform. Its lead commercial product, IDEFIRIX (imlifidase), is a first-in-class bacterial enzyme therapy conditionally approved in the EU, UK, Australia, Israel, and Switzerland for desensitization of highly sensitized adult kidney transplant patients. The company is preparing for U.S. market entry pending FDA approval (PDUFA December 19, 2026), and is advancing a next-generation enzyme, HNSA-5487, for Guillain-Barré syndrome.
Is Hansa Biopharma a public or private company?
Hansa Biopharma is a public company. It is classified as public and is currently operating.
When was Hansa Biopharma founded?
Hansa Biopharma was founded in 2012. It employs 101 to 250 people.
Where is Hansa Biopharma based?
Hansa Biopharma is headquartered in Lund, Sweden, in the Europe region.
How does Hansa Biopharma make money?
Three revenue lines are on record. Product Sales - IDEFIRIX is the primary driver. The others are out-licensing - SERB Pharmaceuticals and non-dilutive Financing - NovaQuest.
Who are Hansa Biopharma's main competitors?
Emerging players on record are argenx, Alnylam Pharmaceuticals and Sarepta Therapeutics. Broad incumbents are Astellas Pharma, Bristol Myers Squibb, Sanofi and Vertex Pharmaceuticals. Direct peers are Veloxis Pharmaceuticals and CareDx. Bio-Rad Laboratories is listed as an others.
Does Hansa Biopharma have an API?
No public API is recorded for Hansa Biopharma.
What industry is Hansa Biopharma in?
Hansa Biopharma's product category is Biopharmaceuticals / Rare Disease Therapeutics. Its primary akta.pro industry code is HLAIACAJ, Transplant & Immunosuppression Specialty Pharmaceuticals, with a secondary code of HLAIAAAD, Immunology & Inflammation Pharmaceuticals. Its NAICS code is 325414 and its SIC code is 2836.