DelveInsight's "Hemophilia B Pipeline Insight 2025" report delivers extensive analysis on over 15 companies and more than 20 pipeline drugs in the Hemophilia B treatment arena. It includes thorough profiles of Hemophilia B pipeline drugs, encompassing clinical and nonclinical development stages. Additionally, it evaluates Hemophilia B pipeline therapeutics by product category, development phase, administration method, and molecular structure. It also points out discontinued pipeline products in this domain.
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Key Takeaways from the Hemophilia B Pipeline Report
On September 3, 2025, Pfizer disclosed a long-term safety and effectiveness follow-up for individuals with Hemophilia B previously involved in the C0371005 (formerly SPK-9001-101) trial. Additionally, the company is launching a dose-escalation sub-study to assess the safety, tolerability, and pharmacokinetics of a higher dose, alongside extended safety and efficacy monitoring. Importantly, participation in this sub-study does not require prior involvement in the original C0371005 trial.
DelveInsight's Hemophilia B Pipeline report illustrates a vibrant arena with over 15 active contributors developing more than 20 pipeline treatments for Hemophilia B care.
The prominent Hemophilia B Companies include Shanghai Vitalgen BioPharma, Belief BioMed, TiumBio, Jiangsu Gensciences, Centessa Pharmaceuticals, Takeda, Sanofi, GC Biopharma Corp, Equilibra Bioscience LLC, Regeneron Pharmaceuticals, ISU Abxis, and others.
Promising Hemophilia B Therapies include REGV131, LNP1265, APVO101, SPK-9001, ANB-002, Benefix, IB1001, marstacimab, and others.
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Hemophilia B Emerging Drugs Profile
BBM-H901: Belief Biomed BBM-H901 is intended for preventive treatment of bleeding in adults with hemophilia B. BBM-H901 aims to restore the production of factor IX (FIX), the blood-clotting protein that is defective or absent in individuals with hemophilia B, by introducing a functional version of the F9 gene to liver cells, the primary sites of clotting factor production. Gene therapy elements are transported to liver cells via a modified, safe adeno-associated virus (AAV) acting as a carrier. The gene therapy is administered as a single intravenous infusion. The drug BBM-H901 is in Phase III clinical trials for hemophilia B treatment.
ISU304: ISU ABXIS ISU304 (Dalcinonacog alfa, DalcA) is an engineered recombinant Factor IX protein for preventive care of patients with Hemophilia B, resulting from a lack of coagulation FIX. It is formulated for subcutaneous administration and reaches standard FIX activity levels to avert bleeding in hemophilia B patients. Existing approved protein replacement therapies for hemophilia B depend on intravenous delivery. With subcutaneous administration, ISU304 is anticipated to enhance patient quality of life and treatment ease. The drug is in Phase II clinical trials for hemophilia B.
TU7710: TiumBio TU7710 is a bypassing agent for individuals with neutralizing antibodies, featuring an extended half-life 6~7 times longer than traditional options via transferrin fusion gene recombination technology. TU7710 is poised to significantly enhance convenience and quality of life for hemophilia patients with neutralizing antibodies. The drug is currently in Phase I clinical trials for Hemophilia B.
The Hemophilia B Pipeline Report Provides Insights into
The report furnishes comprehensive details on organizations advancing therapies for Hemophilia B, including the total treatments each company is developing.
It examines various therapeutic candidates categorized into initial, intermediate, and advanced development stages for Hemophilia B management.
Hemophilia B Companies are engaged in precision therapeutics with ongoing and paused (inactive or halted) initiatives.
Hemophilia B Drugs in progress, sorted by development phase, delivery route, target receptor, standalone or combined therapy, unique action mechanisms, and molecular category.
Comprehensive review of partnerships (corporate alliances and academic collaborations), licensing deals, and funding information to drive future growth in the Hemophilia B market.
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Hemophilia B Companies Shanghai Vitalgen BioPharma, Belief BioMed, TiumBio, Jiangsu Gensciences, Centessa Pharmaceuticals, Takeda, Sanofi, GC Biopharma Corp, Equilibra Bioscience LLC, Regeneron Pharmaceuticals, ISU Abxis, and others.
Hemophilia B pipeline report assesses the therapeutic potential of pipeline drugs by Route of Administration. Products are grouped under different ROAs, including
Oral
Intravenous
Subcutaneous
Parenteral
Topical
Hemophilia B Products have been categorized under various Molecule types such as
Recombinant fusion proteins
Small molecule
Monoclonal antibody
Peptide
Polymer
Gene therapy
Learn about emerging Hemophilia B drugs, pipeline advancements, and key companies with DelveInsight's expert analysis @ Hemophilia B Market Drivers and Barriers
Scope of the Hemophilia B Pipeline Report
Coverage- Global
Hemophilia B Companies- Shanghai Vitalgen BioPharma, Belief BioMed, TiumBio, Jiangsu Gensciences, Centessa Pharmaceuticals, Takeda, Sanofi, GC Biopharma Corp, Equilibra Bioscience LLC, Regeneron Pharmaceuticals, ISU Abxis, and others.
Hemophilia B Therapies- REGV131, LNP1265, APVO101, SPK-9001, ANB-002, Benefix, IB1001, marstacimab, and others.
Hemophilia B Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
Hemophilia B Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
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Table of Contents
Introduction
Executive Summary
Hemophilia B: Overview
Pipeline Therapeutics
Therapeutic Assessment
Hemophilia B - DelveInsight's Analytical Perspective
Late Stage Products (Phase III)
BBM-H901: Belief Biomed
Drug profiles in the detailed report.....
Mid Stage Products (Phase II)
ISU304: ISU ABXIS
Drug profiles in the detailed report.....
Early Stage Products (Phase I)
TU7710: TiumBio
Drug profiles in the detailed report.....
Preclinical and Discovery Stage Products
Drug name: Company name
Drug profiles in the detailed report.....
Inactive Products
Hemophilia B Key Companies
Hemophilia B Key Products
Hemophilia B - Unmet Needs
Hemophilia B - Market Drivers and Barriers
Hemophilia B - Future Perspectives and Conclusion
Hemophilia B Analyst Views
Hemophilia B Key Companies
Appendix
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