DelveInsight’s, “Hemophilia B Pipeline Insight 2025” report provides comprehensive insights about 15+ companies and 20+ pipeline drugs in Hemophilia B pipeline landscape. It covers the Hemophilia B Pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Hemophilia B Pipeline Therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Curious about the latest updates in the Hemophilia B Pipeline? Click here to explore the therapies and trials making headlines @ Hemophilia B Pipeline Outlook Report

Key Takeaways from the Hemophilia B Pipeline Report

• On 06 October 2025, Bayer announced a Phase 1/2 Open-label Safety and Dose-finding Study of BAY2599023 (DTX201), an Adeno-associated Virus (AAV) hu37-mediated Gene Transfer of B-domain Deleted Human Factor VIII, in Adults With Severe Hemophilia A
• DelveInsight’s Hemophilia B Pipeline report depicts a robust space with 15+ active players working to develop 20+ pipeline therapies for Hemophilia B treatment.
• The leading Hemophilia B Companies such as 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 such as REGV131, LNP1265, APVO101, SPK-9001, ANB-002, Benefix, IB1001, marstacimab and others.

Want to know which companies are leading innovation in Hemophilia B? Dive into the full pipeline insights @ Hemophilia B Clinical Trials Assessment

The Hemophilia B Pipeline Report provides disease overview, pipeline scenario and therapeutic assessment of the key pipeline therapies in this domain. The Hemophilia B Pipeline Report also highlights the unmet needs with respect to the Hemophilia B.

Hemophilia B Overview

Hemophilia B is a rare genetic bleeding disorder characterized by a deficiency in factor IX clotting activity, leading to prolonged oozing after injuries, tooth extractions, or surgery, and delayed or recurrent bleeding prior to complete wound healing. The age of diagnosis and frequency of bleeding episodes are related to the level of factor IX clotting activity. In severe cases, individuals may experience frequent spontaneous bleeding episodes, including joint or muscle bleeds, while those with moderate hemophilia B may have less frequent bleeding, typically after minor trauma. Individuals with mild hemophilia B usually do not have spontaneous bleeding episodes but may experience abnormal bleeding during surgery or tooth extractions. The severity of the condition and the frequency of bleeding episodes vary based on the level of factor IX activity, with severe cases usually diagnosed in early childhood and milder cases potentially not being diagnosed until later in life.

Hemophilia B Emerging Drugs Profile

• BBM-H901: Belief Biomed

BBM-H901 is indicated for prophylactic treatment of bleeding in adults with hemophilia B. BBM-H901 is designed to restore the production of factor IX (FIX) the blood-clotting protein that is faulty or missing in people with hemophilia B by delivering a functional copy of the F9 gene to liver cells, which are the main producers of clotting factors in the body. Gene therapy components are delivered to liver cells by a modified, harmless adeno-associated virus (AAV) that works as a vehicle. The gene therapy is given as a single intravenous (into-the-vein) infusion. The drug BBM-H901 is in the Phase III clinical trial for the treatment of hemophilia B.

• ISU304: ISU ABXIS

ISU304 (Dalcinonacog alfa, DalcA) is a modified recombinant Factor IX protein for the prophylactic therapy of patients with Hemophilia B which is caused by a deficiency of coagulation FIX. It is designed to be administered subcutaneously and achieves normal FIX activity levels to prevent bleeding of patients with hemophilia B. Currently approved protein replacement therapy for hemophilia B rely on intravenous injection. With a subcutaneous injection, ISU304 is expected to improve the quality of life and treatment convenience in patients with hemophilia B. The drug is in phase II stage of its clinical trial for the treatment of hemophilia B.

• TU7710: TiumBio

TU7710 is a bypassing agent treatment for patients with neutralizing antibodies and is an innovative drug candidate with a half-life 6~7 times greater than conventional treatments through our transferrin fusion gene recombination technology. TU7710 is expected to dramatically improve the convenience and quality of life of hemophilia patients with neutralizing antibodies. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Hemophilia B.

If you’re tracking ongoing Hemophilia B Clinical trials, this press release is a must-read. Tap to see the breakthroughs @ Hemophilia B Treatment Drugs

The Hemophilia B Pipeline report provides insights into:-

• The report provides detailed insights about companies that are developing therapies for the treatment of Hemophilia B 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 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.

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 provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• 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

From emerging drug candidates to competitive intelligence, the Hemophilia B Pipeline Report covers it all – check it out now @ Hemophilia B Market Drivers and Barriers, and Future Perspectives

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

Stay ahead in Healthcare Research – discover what’s next for the Hemophilia B Treatment landscape in this detailed analysis @ Hemophilia B Emerging Drugs and Major Players

Table of Contents

1. Introduction
2. Executive Summary
3. Hemophilia B: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Hemophilia B – DelveInsight’s Analytical Perspective
7. Late Stage Products (Phase III)
8. BBM-H901: Belief Biomed
9. Drug profiles in the detailed report…..
10. Mid Stage Products (Phase II)
11. ISU304: ISU ABXIS
12. Drug profiles in the detailed report…..
13. Early Stage Products (Phase I)
14. TU7710: TiumBio
15. Drug profiles in the detailed report…..
16. Preclinical and Discovery Stage Products
17. Drug name: Company name
18. Drug profiles in the detailed report…..
19. Inactive Products
20. Hemophilia B Key Companies
21. Hemophilia B Key Products
22. Hemophilia B – Unmet Needs
23. Hemophilia B – Market Drivers and Barriers
24. Hemophilia B – Future Perspectives and Conclusion
25. Hemophilia B Analyst Views
26. Hemophilia B Key Companies
27. Appendix

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