(Albany, USA) DelveInsight’s “Severe Asthma Pipeline Insight 2025” report delivers an extensive evaluation of the Severe Asthma pipeline, featuring insights on 40+ companies developing 50+ investigational therapies. The analysis offers a thorough commercial and clinical review of pipeline candidates across all stages—from preclinical research to marketed products. It further includes detailed drug profiles covering mechanisms of action, clinical trial progress, regulatory milestones such as NDA submissions or approvals, and key development activities including technological innovations, partnerships, mergers, acquisitions, funding, and special designations.
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Key Takeaways from the Severe Asthma Pipeline Report
- GSK’s depemokimab, a long-acting anti-IL-5 monoclonal antibody for treating severe type 2 inflammatory asthma, has been accepted for FDA review, with a decision expected by December 16, 2025.
- In March 2025, AstraZeneca initiated a study to determine whether patients receiving subcutaneous tezepelumab can safely taper their maintenance therapy while maintaining asthma control in adolescents and adults with severe disease.
- In March 2025, Upstream Bio Inc. launched a trial evaluating the safety and efficacy of verekitug (UPB-101) in individuals with severe asthma, focusing on exacerbation rates, lung function, asthma control, and overall tolerability compared with placebo.
- In January 2025, AstraZeneca began a multicenter, randomized, open-label Phase IIIb trial assessing whether tezepelumab-treated patients can reduce maintenance therapy without losing asthma control by Week 56, and whether they achieve clinical remission-like features by Week 24.
- In January 2025, Upstream Bio initiated another study of verekitug (UPB-101) to further evaluate its effectiveness, pharmacodynamic effects, safety, and tolerability in severe asthma.
- In January 2025, Incyte Corporation launched a Phase II, double-blind, placebo-controlled, dose-ranging study of povorcitinib to assess its impact on pulmonary function in participants with inadequately controlled moderate to severe asthma.
- According to DelveInsight, the severe asthma pipeline is highly active, with 40+ companies developing over 50 investigational therapies.
- Key players in the field include Kinaset Therapeutics, Bio-Thera Solutions, CSPC ZhongQi Pharmaceutical Technology, AB Science, GlaxoSmithKline, Oneness Biotech, Biosion, Lanier Biotherapeutics, Kymera Therapeutics, Suzhou Connect Biopharmaceuticals, Upstream Bio, Teva, and others.
- Notable emerging therapies for severe asthma include Verekitug (UPB-101), FB704A, TQC2731, Benralizumab, Povorcitinib, CM326, among additional pipeline candidates.
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Severe Asthma Emerging Drugs
• GSK3511294 – GlaxoSmithKline
GSK3511294, also known as depemokimab, is a long-acting monoclonal antibody that targets the interleukin-5 (IL-5) receptor. Developed by GlaxoSmithKline, it is designed with an extended half-life and enhanced IL-5 binding affinity compared to earlier IL-5 inhibitors. The therapy is currently undergoing Phase III clinical trials for the management of severe asthma.
• BSI-045B – Biosion
BSI-045B is a humanized, high-affinity monoclonal antibody directed against thymic stromal lymphopoietin (TSLP), a cytokine involved in the development of asthma, atopic dermatitis, and various Th2-driven eosinophilic disorders. Biosion’s partner, CTTQ—a China-based company holding development and commercialization rights for China—is conducting a Phase II clinical trial evaluating BSI-045B (TQC2731) for patients with severe uncontrolled asthma.
• Mepolizumab – Bio-Thera Solutions
Mepolizumab is an interleukin-5 (IL-5) antagonist monoclonal antibody delivered subcutaneously via syringe or autoinjector. It is approved as an add-on maintenance therapy for multiple eosinophilic conditions, including severe eosinophilic asthma (ages ≥6), chronic rhinosinusitis with nasal polyps (adults), eosinophilic granulomatosis with polyangiitis (adults), and hypereosinophilic syndrome (ages ≥12). Bio-Thera Solutions is currently evaluating mepolizumab in a Phase I clinical trial for the treatment of severe asthma.
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Severe Asthma Companies
Kinaset Therapeutics, Bio-Thera Solutions, CSPC ZhongQi Pharmaceutical Technology, AB Science, GlaxoSmithKline, Oneness Biotech, Biosion, Lanier Biotherapeutics, Kymera Therapeutics, Suzhou Connect Biopharmaceuticals, Upstream Bio, Teva Branded Pharmaceutical Industries, and others.
Severe Asthma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration
- Oral
- Intravenous
- Subcutaneous
- Parenteral
- Topical
Severe Asthma Products have been categorized under various Molecule types such as
- Recombinant fusion proteins
- Small molecule
- Monoclonal antibody
- Peptide
- Polymer
- Gene therapy
Unveil the future of Severe Asthma Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight’s expert analysis @ Severe Asthma Market Drivers and Barriers
Severe Asthma Market Drivers
- Rising Prevalence of Severe Asthma Increasing incidence of asthma with a high eosinophilic phenotype and uncontrolled symptoms continues to expand the target patient pool.
- Growing Adoption of Biologics and Targeted Therapies Advancements in monoclonal antibodies targeting IL-5, IL-4/13, IgE, and TSLP are driving significant market growth by offering improved symptom control and reducing exacerbations.
- Enhanced Diagnostic Capabilities Increased use of biomarkers (eosinophil counts, FeNO), phenotyping, and precision medicine approaches are enabling better patient stratification and treatment optimization.
- Rising Healthcare Awareness and Treatment Availability Improved physician awareness, patient education, and increasing access to specialty care centers contribute to higher diagnosis and treatment rates.
- Favorable Reimbursement Policies in Developed Markets Supportive health insurance systems in the US and EU facilitate access to high-cost biologics, expanding market uptake.
- Growing Pipeline of Novel Therapies Strong R&D activity focused on long-acting biologics, small molecules, and next-generation anti-inflammatory pathways boosts market momentum.
Severe Asthma Market Barriers
- High Cost of Biologic Therapies Premium pricing of targeted biologics limits accessibility, especially in low and middle-income regions, and poses reimbursement challenges.
- Complexity in Diagnosis and Phenotyping Accurate identification of severe asthma subtypes requires advanced diagnostic tools, which may not be readily available in all healthcare settings.
- Treatment Adherence Issues Long-term therapy requirements, injection burden, and variability in patient response often hinder consistent treatment adherence.
- Limited Adoption in Emerging Markets Low awareness, inadequate infrastructure, and financial constraints restrict the use of advanced biologics outside major developed regions.
- Risk of Adverse Effects and Long-Term Safety Concerns Potential side effects and limited long-term safety data for newer biologics may slow physician adoption.
- Regulatory and Market Access Challenges Lengthy approval processes and strict regulatory requirements can delay the entry of new therapies into key markets.
Scope of the Severe Asthma Pipeline Report
- Coverage- Global
- Severe Asthma Companies- Kinaset Therapeutics, Bio-Thera Solutions, CSPC ZhongQi Pharmaceutical Technology, AB Science, GlaxoSmithKline, Oneness Biotech, Biosion, Lanier Biotherapeutics, Kymera Therapeutics, Suzhou Connect Biopharmaceuticals, Upstream Bio, Teva Branded Pharmaceutical Industries, and others.
- Severe Asthma Therapies- Verekitug (UPB-101), FB704A, TQC2731, Benralizumab, povorcitinib, CM326, and others.
- Severe Asthma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
- Severe Asthma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
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Table of Content
- Introduction
- Executive Summary
- Severe Asthma: Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- Severe Asthma– DelveInsight’s Analytical Perspective
- Late Stage Products (Phase III)
- GSK3511294: GlaxoSmithKline
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- BSI-045B: Biosion
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I)
- Mepolizumab: Bio-Thera Solutions
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- Drug name: Company name
- Drug profiles in the detailed report…..
- Inactive Products
- Severe Asthma Key Companies
- Severe Asthma Key Products
- Severe Asthma- Unmet Needs
- Severe Asthma- Market Drivers and Barriers
- Severe Asthma- Future Perspectives and Conclusion
- Severe Asthma Analyst Views
- Severe Asthma Key Companies
- Appendix
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