Hansa Biopharma publishes 2024 Annual and Sustainability Reports
Hansa Biopharma (NASDAQ Stockholm: HNSA) has published its 2024 Annual and Sustainability Reports, highlighting significant achievements including an 83% year-on-year growth in IDEFIRIX® sales. The company expanded market access to 18 European markets for IDEFIRIX® as a desensitization treatment for kidney transplant patients.
Key 2024 milestones include:
- Completion of randomization in the pivotal Phase 3 ConfIdeS trial, with BLA submission to FDA planned for 2H 2025
- Successful results from NICE-01 trial of HNSA-5487, targeting myasthenia gravis
- Completion of GOOD-IDES-02 Phase 3 trial enrollment in anti-GBM disease
- Positive results from Phase 2 study in Guillain-Barré Syndrome
- Progress in gene therapy collaborations with Genethon and Sarepta
The company maintained its Great Place to Work® certification for the fifth consecutive year with 95% survey participation, while conducting its first Double Materiality Assessment to enhance sustainability practices.
Hansa Biopharma (NASDAQ Stoccolma: HNSA) ha pubblicato i suoi Rapporti Annuali e di Sostenibilità per il 2024, evidenziando risultati significativi, tra cui una crescita dell'83% anno su anno nelle vendite di IDEFIRIX®. L'azienda ha ampliato l'accesso al mercato a 18 mercati europei per IDEFIRIX® come trattamento di desensibilizzazione per i pazienti trapiantati di rene.
I principali traguardi del 2024 includono:
- Completamento della randomizzazione nello studio clinico cruciale di Fase 3 ConfIdeS, con presentazione della BLA all'FDA prevista per il secondo semestre del 2025
- Risultati positivi dallo studio NICE-01 di HNSA-5487, mirato alla miastenia gravis
- Completamento dell'arruolamento nello studio di Fase 3 GOOD-IDES-02 per la malattia anti-GBM
- Risultati positivi dallo studio di Fase 2 nella Sindrome di Guillain-Barré
- Progressi nelle collaborazioni per la terapia genica con Genethon e Sarepta
L'azienda ha mantenuto la certificazione di Great Place to Work® per il quinto anno consecutivo con una partecipazione del 95% al sondaggio, mentre ha condotto la sua prima Valutazione di Doppia Materialità per migliorare le pratiche di sostenibilità.
Hansa Biopharma (NASDAQ Estocolmo: HNSA) ha publicado sus Informes Anuales y de Sostenibilidad para 2024, destacando logros significativos, incluyendo un crecimiento del 83% interanual en las ventas de IDEFIRIX®. La compañía amplió el acceso al mercado a 18 mercados europeos para IDEFIRIX® como tratamiento de desensibilización para pacientes trasplantados de riñón.
Los hitos clave de 2024 incluyen:
- Finalización de la aleatorización en el ensayo pivotal de Fase 3 ConfIdeS, con la presentación de la BLA a la FDA prevista para el segundo semestre de 2025
- Resultados exitosos del ensayo NICE-01 de HNSA-5487, dirigido a la miastenia gravis
- Finalización de la inscripción en el ensayo de Fase 3 GOOD-IDES-02 para la enfermedad anti-GBM
- Resultados positivos del estudio de Fase 2 en el Síndrome de Guillain-Barré
- Avances en colaboraciones de terapia génica con Genethon y Sarepta
La compañía mantuvo su certificación de Great Place to Work® por quinto año consecutivo con una participación del 95% en la encuesta, mientras que realizó su primera Evaluación de Doble Materialidad para mejorar las prácticas de sostenibilidad.
한사 바이오파마 (NASDAQ 스톡홀름: HNSA)는 2024년 연례 및 지속 가능성 보고서를 발표하며, IDEFIRIX® 판매에서 연간 83% 성장이라는 중요한 성과를 강조했습니다. 이 회사는 신장 이식 환자를 위한 탈감작 치료제로서 IDEFIRIX®의 유럽 18개 시장에 대한 시장 접근을 확대했습니다.
2024년 주요 이정표는 다음과 같습니다:
- 중요한 3상 ConfIdeS 시험에서 무작위 배정 완료, 2025년 하반기 FDA에 BLA 제출 계획
- 중증 근무력증을 목표로 하는 HNSA-5487의 NICE-01 시험에서 성공적인 결과
- 항-GBM 질환에 대한 GOOD-IDES-02 3상 시험 등록 완료
- 길랭-바레 증후군에 대한 2상 연구에서 긍정적인 결과
- 제네톤 및 사레프타와의 유전자 치료 협력에서의 진전
회사는 95%의 설문 참여율로 5년 연속 Great Place to Work® 인증을 유지했으며, 지속 가능성 관행을 강화하기 위해 첫 번째 이중 물질성 평가를 실시했습니다.
Hansa Biopharma (NASDAQ Stockholm: HNSA) a publié ses Rapports Annuels et de Durabilité pour 2024, mettant en avant des réalisations significatives, y compris une croissance de 83 % des ventes d'IDEFIRIX® par rapport à l'année précédente. L'entreprise a élargi l'accès au marché à 18 marchés européens pour IDEFIRIX® en tant que traitement de désensibilisation pour les patients ayant subi une transplantation rénale.
Les principales étapes de 2024 comprennent:
- Achèvement de la randomisation dans l'essai pivotal de Phase 3 ConfIdeS, avec une soumission de la BLA à la FDA prévue pour le deuxième semestre 2025
- Résultats positifs de l'essai NICE-01 de HNSA-5487, ciblant la myasthénie grave
- Achèvement de l'inscription dans l'essai de Phase 3 GOOD-IDES-02 pour la maladie anti-GBM
- Résultats positifs de l'étude de Phase 2 dans le syndrome de Guillain-Barré
- Progrès dans les collaborations en thérapie génique avec Genethon et Sarepta
L'entreprise a maintenu sa certification Great Place to Work® pour la cinquième année consécutive avec une participation de 95 % au sondage, tout en réalisant sa première Évaluation de Double Matérialité pour améliorer les pratiques de durabilité.
Hansa Biopharma (NASDAQ Stockholm: HNSA) hat ihre Jahres- und Nachhaltigkeitsberichte für 2024 veröffentlicht und dabei bedeutende Erfolge hervorgehoben, darunter ein Umsatzwachstum von 83 % im Jahresvergleich bei IDEFIRIX®. Das Unternehmen hat den Marktzugang für IDEFIRIX® als Desensibilisierungsbehandlung für Nierentransplantationspatienten auf 18 europäische Märkte ausgeweitet.
Wichtige Meilensteine für 2024 sind:
- Abschluss der Randomisierung in der entscheidenden Phase-3-Studie ConfIdeS, mit geplanter BLA-Einreichung bei der FDA im 2. Halbjahr 2025
- Erfolgreiche Ergebnisse der NICE-01-Studie zu HNSA-5487, das auf Myasthenia gravis abzielt
- Abschluss der Rekrutierung für die Phase-3-Studie GOOD-IDES-02 bei anti-GBM-Erkrankungen
- Positive Ergebnisse aus der Phase-2-Studie zum Guillain-Barré-Syndrom
- Fortschritte in der Gentherapie-Zusammenarbeit mit Genethon und Sarepta
Das Unternehmen hat seine Great Place to Work®-Zertifizierung im fünften Jahr in Folge mit einer Umfragebeteiligung von 95 % aufrechterhalten und gleichzeitig seine erste Doppelmaterialitätsbewertung durchgeführt, um die Nachhaltigkeitspraktiken zu verbessern.
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Peter Nicklin, Chair of the Board, Hansa Biopharma, said: "Hansa delivered several important milestones in 2024 and remains on track to advance innovative science and important new medicines. This is in large part due to the dedicated, results-driven employees, and the Company's commitment to delivering on its discovery, development and commercialization goals. In my third year as Chair of the Board of Directors, I remain inspired and excited for what is to come for Hansa."
Søren Tulstrup, President and CEO, Hansa Biopharma, said, "2024 was a momentum-building year for Hansa. With year-on-year IDEFIRIX® sales growth of
2024 highlights
In 2024, Hansa advanced the commercialization of IDEFIRIX® (imlifidase) in
A growing body of data, real-world evidence and clinical guidelines on the utilization of imlifidase as a desensitization strategy for highly sensitized kidney transplant patients has been published. The most recent guidance published in Transplant International provides specific guidelines on appropriate use of imlifidase in clinical practice to enable kidney transplants in highly sensitized patients.
Preparation for commercialization in the US is progressing, with complete randomization of the pivotal Phase 3 trial - ConfIdeS - announced in May 2024. Data readout for the trial and submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) are planned in 2H 2025.
In October 2024, Hansa announced full results of the NICE-01 first in human trial and 12-month follow up analysis of HNSA-5487, demonstrating that it can robustly and rapidly reduce IgG levels, has redosing potential, and a favorable safety and tolerability profile. Initial clinical development will be focused on neuro-autoimmune disease with a well characterized role of specific autoantibodies in disease pathology and recurring acute phases - specifically, myasthenia gravis (MG). The company plans to align with regulatory authorities in the first half of 2025 on a clinical development path for HNSA-5487 in MG.
In Autoimmune, enrolment was completed for the GOOD-IDES-02 Phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease in December, with data readout expected in the second half of 2025. In Guillain-Barré Syndrome (GBS), Hansa announced positive full results from the 15-HMedIdeS-09 single arm Phase 2 study and an indirect treatment comparison to the International Guillain-Barré Syndrome Outcome Study (IGOS) in December 2024.
In Gene Therapy, Hansa and Genethon announced initiation of GNT-018-IDES, a Phase 2 trial sponsored by Genethon evaluating the efficacy and safety of a single intravenous administration of Genethon's gene therapy GNT-0003 following pre-treatment with imlifidase in patients with severe Crigler-Najjar syndrome and pre-formed antibodies to AAV8. Enrolment continues in the SRP-9001-104 Phase 1b trial evaluating the use of imlifidase as a pre-treatment to Sarepta Therapeutics Inc.'s (Sarepta) ELEVIDYS (delandistrogene moxeparvovec) gene therapy in Duchenne Muscular Dystrophy (DMD).
Hansa's journey towards a more sustainable business continues
Over the last three years, Hansa has continuously evolved its approach to Sustainability aligning to the changes happening within the Company and the external environment. This year's Sustainability Report outlines the continued efforts the Company has advanced and our focus for 2025. The report highlights our work to address high unmet medical need in our three core therapy areas - Autoimmune, Gene Therapy and Transplantation, as well as our continued focus on ensuring that we are operating as a transparent, ethical business. Finally, we continue to believe that a diverse, inclusive, and supportive culture is integral to the Company's success.
2024 also marked the first year Hansa conducted a Double Materiality Assessment, an opportunity to better understand the Company's impact on stakeholders and the environment as well as what opportunities influence its business. The output - a list of prioritized material topics - provided insight and perspective on the Company's sustainability strategy and areas of focus for effective risk management.
Hansa uses an annual company-wide survey by Great Place to Work®, a global authority on workplace culture, to seek employee feedback with the purpose of constantly developing and refining a healthy work environment with highly engaged and motivated colleagues. In 2024, Hansa was certified as a Great Place to Work® for the fifth consecutive year, with a
Read the Annual and Sustainability Reports here.
This is information that Hansa Biopharma AB (publ) is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 15:00 CET on 21 March 2025.
Contacts for more information:
Evan Ballantyne, Chief Financial Officer
IR@hansabiopharma.com
Stephanie Kenney, VP Global Corporate Affairs
media@hansabiopharma.com
About Hansa Biopharma
Hansa Biopharma AB is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative, lifesaving and life-altering treatments for patients with rare immunological conditions. The company has a rich and expanding research and development program based on its proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in autoimmune diseases, gene therapy and transplantation. The company's portfolio includes imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients and HNSA-5487, a next-generation IgG cleaving molecule with redosing potential. Hansa Biopharma is based in
©2025 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and IDEFIRIX flower logo are trademarks of Hansa Biopharma AB,
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FAQ
What was Hansa Biopharma's (HNSA) IDEFIRIX sales growth in 2024?
How many European markets have approved IDEFIRIX for kidney transplant patients in 2024?
When will Hansa Biopharma (HNSA) submit its BLA to the FDA for kidney transplantation?
What are the key clinical trial results expected for HNSA in 2025?
What therapeutic areas is Hansa Biopharma (HNSA) focusing on in 2024-2025?
