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(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
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 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 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.
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
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
Table of Contents
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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