Hemophilia B Pipeline 2026 Report Highlights Next-Gen Gene Therapies, FDA Advances, and Clinical Momentum Across Novo Nordisk, Pfizer, Sanofi & Emerging Biotechs | DelveInsight

As per DelveInsight’s assessment, globally, Hemophilia B pipeline constitutes 15+ key companies continuously working towards developing 20+ Hemophilia B treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

“Hemophilia B Pipeline Insight, 2026“ report by DelveInsight outlines comprehensive insights into the present clinical develospment scenario and growth prospects across the Hemophilia B Market.

The Hemophilia B Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

Some of the key takeaways from the Hemophilia B Pipeline Report

• Hemophilia B Companies across the globe are diligently working toward developing novel Hemophilia B treatment therapies with a considerable amount of success over the years. Hemophilia B Key players such as – Belief Biomed, ISU ABXIS, TiumBio, Be Biopharma, Regeneron Pharmaceuticals, Pfizer, Biocad, CSL Behring, Shanghai Vitalgen BioPharma, Baxalta, Amarna therapeutics, Catalyst Biosciences, Freeline Therapeutics, Belief BioMed, Centessa Pharmaceuticals, Novo Nordisk, Sanofi, Pfizer, and others are developing therapies for the Hemophilia B treatment
• Hemophilia B Emerging therapies such as – BBM-H901, ISU304, TU7710, BE-101, REGV131, PF-06838435, ANB-002, AAV5-hFIXco-Padua, VGB-R04, AskBio009, AMA005, CB 2679d-GT, FLT180a, BBM-H901, SerpinPC, Concizumab, Fitusiran, PF-06, and others are expected to have a significant impact on the Hemophilia B market in the coming years.
• In February 2026, Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to its supplemental Biologics License Application (sBLA) for HYMPAVZI. The application seeks to broaden the drug’s approved use to include patients aged 6 years and older with hemophilia A or B who have inhibitors, as well as pediatric patients aged 6 to 11 years with hemophilia A or B without inhibitors. Currently in the United States, HYMPAVZI is approved for patients aged 12 years and older with hemophilia A without factor VIII (FVIII) inhibitors or hemophilia B without factor IX (FIX) inhibitors.
• In January 2026, At the 67th American Society of Hematology (ASH) Annual Meeting and Exposition held in Florida, end-of-study results from the pivotal Phase 3 HOPE-B clinical trial (NCT03569891) were presented. These data underpinned the FDA’s 2022 approval of CSL Behring and uniQure’s etranacogene dezaparvovec, marketed as Hemgenix, an AAV vector–based gene therapy approved for the treatment of hemophilia B.
• In September 2025, Pfizer announced a long-term safety and efficacy follow-up for Hemophilia B patients previously enrolled in the C0371005 (formerly SPK-9001-101) trial. Additionally, the company is launching a dose-escalation sub-study to assess the safety, tolerability, and kinetics of a higher dose, along with extended safety and efficacy monitoring. Importantly, participation in the original C0371005 trial is not a requirement for this sub-study.
• In August 2025, Concizumab-mtci (Alhemo®) has been approved by the US FDA as the first once-daily subcutaneous prophylactic therapy for patients aged 12 and above with hemophilia A or B without inhibitors, broadening its use beyond those previously limited to inhibitor cases.
• In July 2025, Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved Alhemo® (concizumab-mtci) injection as a once-daily prophylactic therapy to prevent or reduce bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B (HA/HB) without inhibitors. This decision expands on the December 2024 approval for patients with HA/HB with inhibitors. Currently, many therapies for HA/HB without inhibitors require intravenous administration; with this approval, Alhemo® provides a subcutaneous treatment alternative for this patient population.
• In April 2025, The FDA approved Qfitlia (fitusiran) for routine prophylaxis to help prevent or reduce bleeding episodes in patients aged 12 years and older with hemophilia A or B, regardless of the presence of factor VIII or IX inhibitors.
• In December 2024, Biopharma initiated the first-in-human Phase 1/2 clinical trial of BE-101, its innovative B-cell therapy for hemophilia B, with patient enrollment underway at two U.S. sites. BE-101, a first-of-its-kind treatment, seeks to address ongoing challenges faced by hemophilia B patients, including the burden of regular treatment and disease management, as many still experience frequent bleeding episodes. The two-part Phase 1/2 trial, named BeCoMe-9 (NCT06611436), is designed to evaluate the safety and clinical activity of a single intravenous infusion of BE-101 in adults with moderately severe to severe hemophilia B.
• In July 2024, CSL Behring has reported the treatment of two patients with HEMGENIX (etranacogene dezaparvovec) gene therapy for haemophilia B, a hereditary bleeding condition. The treatments were administered at haemophilia centres in France. HEMGENIX underwent extensive clinical development led by UniQure, with CSL Behring assuming sponsorship of the trials after acquiring global commercial rights to the therapy.

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Hemophilia B Overview

Hemophilia B is a rare genetic bleeding disorder in which affected individuals have insufficient blood protein levels called factor IX. Hemophilia B, also known as factor IX deficiency or Christmas disease, is the second most common type of hemophilia. Factor IX is a clotting factor. Clotting factors are specialized proteins needed for blood clotting, the process by which blood seals a wound to stop bleeding and promote healing. Individuals with hemophilia B do not bleed faster than unaffected individuals, they bleed longer.

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Hemophilia B Pipeline Therapies along with Key Players:

• BBM-H901: Belief Biomed
• ISU304: ISU ABXIS
• TU7710: TiumBio
• BE-101: Be Biopharma
• REGV131: Regeneron Pharmaceuticals
• PF-06838435: Pfizer
• ANB-002: Biocad
• AAV5-hFIXco-Padua: CSL Behring
• VGB-R04: Shanghai Vitalgen BioPharma
• AskBio009: Baxalta
• AMA005: Amarna therapeutics
• CB 2679d-GT: Catalyst Biosciences
• FLT180a: Freeline Therapeutics
• BBM-H901: Belief BioMed
• SerpinPC: Centessa Pharmaceuticals
• Concizumab: Novo Nordisk
• Fitusiran: Sanofi
• PF-06741086: Pfizer

Hemophilia B Pipeline Therapeutics Assessment

TheHemophilia B Pipeline report proffers an integral view of the Hemophilia B emerging novel therapies segmented by Stage, Product Type, Molecule Type, Mechanism of Action, and Route of Administration.

Hemophilia B Pipeline Clinical Phases:

DelveInsight’s Report covers around 20+ products under different phases of clinical development like

• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Further Hemophilia B product details are provided in the report. Download the Hemophilia B pipeline report to learn more about the emerging Hemophilia B therapies

Some of the key companies in the Hemophilia B Therapeutics Market include:

Key companies developing therapies for Hemophilia B treatment are – Aptevo, Bayer, BioMarin, Catalyst Biosciences, CSL Behring, GC Pharma, Kaifeng Pharmaceutical, KM Biologics, LFB, Novo Nordisk, Pfizer, Octapharma, Roche, Sanofi, SinoCelltech, Spark Therapeutics, Takeda, UniQure, and others.

Hemophilia B Pipeline Analysis:

The report provides insights into

• The report provides detailed insights about companies that are developing therapies for the Hemophilia B treatment with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Hemophilia B Treatment.
• Hemophilia B key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Hemophilia B Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Hemophilia B market.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Hemophilia B Pipeline Market Drivers

• Increasing prevalence of Hemophilia B disease
• Increasing R&D on identifying new therapeutic agents

Hemophilia B Pipeline Market Barriers

• High cost of Hemophilia B treatment

Scope of Hemophilia B Pipeline Drug Insight

• Coverage: Global
• Key Hemophilia B Companies: Belief Biomed, ISU ABXIS, TiumBio, Be Biopharma, Regeneron Pharmaceuticals, Pfizer, Biocad, CSL Behring, Shanghai Vitalgen BioPharma, Baxalta, Amarna therapeutics, Catalyst Biosciences, Freeline Therapeutics, Belief BioMed, Centessa Pharmaceuticals, Novo Nordisk, Sanofi, Pfizer, and others
• Key Hemophilia B Therapies: BBM-H901, ISU304, TU7710, BE-101, REGV131, PF-06838435, ANB-002, AAV5-hFIXco-Padua, VGB-R04, AskBio009, AMA005, CB 2679d-GT, FLT180a, BBM-H901, SerpinPC, Concizumab, Fitusiran , PF-06, and others
• Hemophilia B Therapeutic Assessment: Hemophilia B current marketed and Hemophilia B emerging therapies
• Hemophilia B Market Dynamics: Hemophilia B market drivers and Hemophilia B market barriers

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Table of Contents

1. Hemophilia B Report Introduction

2. Hemophilia B Executive Summary

3. Hemophilia B Overview

4. Hemophilia B- Analytical Perspective In-depth Commercial Assessment

5. Hemophilia B Pipeline Therapeutics

6. Hemophilia B Late Stage Products (Phase II/III)

7. Hemophilia B Mid Stage Products (Phase II)

8. Hemophilia B Early Stage Products (Phase I)

9. Hemophilia B Preclinical Stage Products

10. Hemophilia B Therapeutics Assessment

11. Hemophilia B Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Hemophilia B Key Companies

14. Hemophilia B Key Products

15. Hemophilia B Unmet Needs

16. Hemophilia B Market Drivers and Barriers

17. Hemophilia B Future Perspectives and Conclusion

18. Hemophilia B Analyst Views

19. Appendix

20. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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