Hemophilia B Pipeline 2025: MOA, ROA, FDA-Approved Drugs, and Clinical Trial Progress Assessment by DelveInsight | Novo Nordisk, Sanofi, Pfizer, Belief BioMed, Centessa Pharmaceuticals

(Las Vegas, Nevada, United States) 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, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development 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 https://www.delveinsight.com/sample-request/hemophilia-b-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
• 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 June 2025, A 13-year follow-up study showed that a one-time gene therapy treatment for hemophilia B led to long-lasting factor IX production, maintained clinical improvements, and no delayed safety issues. These long-term findings, published in The New England Journal of Medicine, reinforce the potential of gene therapy as a treatment option for individuals with hemophilia B.
• In April 2025, China approved the gene therapy BBM-H901 (dalnacogene ponparvovec) for adults with moderate to severe hemophilia B, marking the country's first authorized gene therapy for the condition. Developed and produced by Belief Biomed (BBM), the therapy will be marketed across mainland China, Hong Kong, and Macau by Takeda China.
• In April 2025, Findings from a Phase 3 open-label extension study indicate that fitusiran, used with an antithrombin-based dose regimen (AT-DR), demonstrated both effectiveness and tolerability in patients with hemophilia A or B. Published in the journal Blood, the ATLAS-OLE trial (ClinicalTrials.gov Identifier: NCT03754790) involved male patients aged 12 and older with severe hemophilia A or B, with or without inhibitors, who had previously completed a Phase 3 fitusiran trial. The study assessed the safety and efficacy of the AT-DR approach, which optimized dosing to maintain antithrombin activity between 15% and 35%, aiming to reduce the risk of thrombosis.
• In December 2024, Be 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.

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
The Hemophilia 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
https://www.delveinsight.com/sample-request/hemophilia-b-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

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

Download the Hemophilia B pipeline report to learn more about the emerging Hemophilia B therapies
https://www.delveinsight.com/sample-request/hemophilia-b-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

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

Get a Free Sample PDF Report to know more about Hemophilia B Pipeline Assessment
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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

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