Hansa Biopharma

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.

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

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

• Immunomodulatory therapies
• Biopharmaceutical products
• Kidney transplantation
• Rare disease treatments
• Antibody-cleaving enzymes

Headquarters

HQ city

Lund

HQ country

Sweden

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Marketing or Sales, Operations

Revenue model

1. Product Sales - IDEFIRIX: Commercial product revenue from IDEFIRIX sales in European markets. 46% growth in European product revenue in 2025. Coverage in 24 countries.
2. 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.
3. 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

Core 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.

Named customers2 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

Four partnerships are on record, tiered core and minor.

• SERB PharmaceuticalscoreChannel Partner/ Reseller/ Distributor · 19 May 2026SERB 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.
• GenethoncoreStrategic or Co-development Partner · 10 October 2025Collaboration 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.
• SareptaminorStrategic or Co-development PartnerPartnership 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.
• EurotransplantcoreStrategic or Co-development PartnerEurotransplant 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

Emerging 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

• Xx.com/HansaBiopharma
• Facebookfacebook.com/hansabiopharma
• LinkedInlinkedin.com/company/hansa-medical-ab

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Funding overview

Funding rounds4 records

Investors8 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Hansa Biopharma