Vasculitis Pipeline: Pioneering Progress with 25+ Leading Companies Developing Groundbreaking Therapies | DelveInsight

The Vasculitis market is rapidly advancing and is fueled by groundbreaking research and innovative therapies from companies such as Mitsubishi Tanabe Pharma Corporation, Yake Biotechnology, and Kyverna Therapeutics. These industry pioneers are transforming treatment strategies and redefining the future of Vasculitis, bringing new hope to patients worldwide.

DelveInsight's "Vasculitis Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the Vasculitis market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.

For emerging Vasculitis drugs, the Vasculitis pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

Key Takeaways from the Vasculitis Pipeline Report
• DelveInsight's Vasculitis Pipeline analysis depicts a robust space with 25+ active players working to develop 30+ pipeline drugs for Vasculitis treatment.
• The leading Vasculitis companies include Mitsubishi Tanabe Pharma Corporation, Yake Biotechnology Ltd., Kyverna Therapeutics, Guangdong Hengrui Pharmaceutical Co., Ltd, InflaRx GmbH, Ganzhou Hemay Pharmaceutical Co., Ltd., and others are evaluating their lead assets to improve the Vasculitis treatment landscape.
• Key Vasculitis pipeline therapies in various stages of development include MT-2990, CD19/BCMA CAR T-cells, KYV-101, SHR-1703, IFX-1, Hemay005, and others.
• In September 2024, AstraZeneca's Fasenra (benralizumab) was approved in the U.S. for treating adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare and potentially fatal vasculitis affecting multiple organs.
• In June 2024, NovelMed announced FDA clearance for its investigational drug, Ruxoprubart, to begin an efficacy trial for ANCA-associated vasculitis (AAV), a chronic autoimmune vasculitis causing inflammation in small blood vessels.
• Also in June 2024, Nkarta, Inc. initiated the Ntrust-1 clinical trial of NKX019 for lupus nephritis and received FDA clearance for a second IND for NKX019, targeting autoimmune diseases including systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), and AAV.

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Vasculitis Overview
Vasculitis refers to a group of rare diseases characterized by inflammation of blood vessels, including both arteries and veins. These conditions can vary significantly in terms of symptoms, severity, and duration. While the exact causes of most types of vasculitis remain unknown, the disease can affect individuals of all ages and genders. However, some forms are more common in specific groups-for example, Kawasaki disease occurs exclusively in children, IgA vasculitis is more prevalent in children than adults, and giant cell arteritis affects only adults over 50.

Vasculitis can lead to reduced blood flow to various organs and tissues, such as the lungs, nerves, and skin. The classification of vasculitis depends on the size and location of the affected blood vessels. Large vessel vasculitis includes conditions like giant cell arteritis, Takayasu's arteritis, and aortitis associated with Cogan's syndrome or spondylarthropathies. Medium vessel vasculitis includes Kawasaki disease and polyarteritis nodosa. Some conditions, such as Behçet's disease and relapsing polychondritis, can affect arteries and veins of various sizes. When blood vessels become inflamed, the tissues and organs they supply may receive insufficient blood, potentially leading to severe damage and even life-threatening complications.

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Vasculitis Treatment Analysis: Drug Profile
Hemay-005: Ganzhou Hemay Pharmaceutical
Hemay-005 is an investigational therapy being developed for the treatment of moderate to severe ulcerative colitis, plaque psoriasis, atopic dermatitis, Behçet's disease, and ankylosing spondylitis. The drug is administered orally in both tablet and suspension forms. It functions by targeting phosphodiesterase 4 (PDE4) and is classified as a novel small-molecule chemical entity. Currently, Hemay-005 is in Phase III clinical development for the treatment of vasculitis.

SHR-1703: Guangdong Hengrui Pharmaceutical
SHR-1703 is an injectable humanized anti-IL-5 monoclonal antibody (IgG1 subtype) designed to bind to IL-5, thereby inhibiting the IL-5/IL-5R signaling pathway. This mechanism helps suppress the proliferation, activation, and migration of eosinophils, ultimately reducing asthma exacerbations, improving lung function, and enhancing patients' quality of life. Three IL-5/IL-5R-targeting monoclonal antibodies have already received global approval: Mepolizumab (GlaxoSmithKline), Reslizumab (Teva), and Benralizumab (AstraZeneca), all indicated as additional maintenance treatments for eosinophilic granulocytic asthma. Currently, SHR-1703 is in Phase II/III clinical development for the treatment of vasculitis.

Key Vasculitis Therapies and Companies
• Hemay005: Ganzhou Hemay Pharmaceutical
• SHR-1703: Guangdong Hengrui Pharmaceutical
• KYV-101: David Porter|Kyverna Therapeutics|University of Pennsylvania

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Vasculitis Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• 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

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

By Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Scope of the Vasculitis Pipeline Report
• Coverage: Global
• Key Vasculitis Companies: itsubishi Tanabe Pharma Corporation, Yake Biotechnology Ltd., Kyverna Therapeutics, Guangdong Hengrui Pharmaceutical Co., Ltd, InflaRx GmbH, Ganzhou Hemay Pharmaceutical Co., Ltd., and others.
• Key Vasculitis Pipeline Therapies: MT-2990, CD19/BCMA CAR T-cells, KYV-101, SHR-1703, IFX-1, Hemay005, and others.

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Table of Contents
1. Introduction
2. Executive Summary
3. Vasculitis Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Vasculitis Pipeline Therapeutics
6. Vasculitis Pipeline: Late-Stage Products (Phase III)
7. Vasculitis Pipeline: Late-Stage Products (Phase III)
8. Vasculitis Pipeline: Mid-Stage Products (Phase II)
9. Vasculitis Pipeline: Early Stage Products (Phase I)
10. Therapeutic Assessment
11. Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix

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This release was published on openPR.