Ankylosing Spondylitis Pipeline 2025: FDA Updates, Therapy Innovations, and Clinical Trial Landscape Analysis by DelveInsight | Pfizer, UCB Biopharma, Fresenius Kabi, Shanghai Henlius Biotech

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Ankylosing Spondylitis pipeline constitutes 20+ key companies continuously working towards developing 20+ Ankylosing Spondylitis treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

The Ankylosing Spondylitis 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

"Ankylosing Spondylitis Pipeline Insight, 2025 [https://www.delveinsight.com/sample-request/ankylosing-spondylitis-bekhterevs-disease-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Ankylosing Spondylitis Market..

Some of the key takeaways from the Ankylosing Spondylitis Pipeline Report:

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Companies across the globe are diligently working toward developing novel Ankylosing Spondylitis treatment therapies with a considerable amount of success over the years.

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Ankylosing Spondylitis companies working in the treatment market are Kinevant Sciences, MoonLake Immunotherapeutics, Qyuns Therapeutics, Suzhou Zelgen Biopharmaceuticals, Jiangsu HengRui MedicIne, Suzhou Zelgen Biopharmaceuticals, Amgen, and others, are developing therapies for the Ankylosing Spondylitis treatment

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Emerging Ankylosing Spondylitis therapies in the different phases of clinical trials are- KIN-1901, Sonelokimab, QX 002N, SHR-1314, SHR0302, Jaktinib, Apremilast, and others are expected to have a significant impact on the Ankylosing Spondylitis market in the coming years.

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In June 2025, UCB, a global biopharmaceutical company, has released new three-year data from its Phase 3 clinical trials and open-label extension studies evaluating BIMZELX Registered (bimekizumab-bkzx) in adults with active psoriatic arthritis (PsA) and active axial spondyloarthritis (axSpA), which includes both non-radiographic axial spondyloarthritis (nr-axSpA) with objective inflammation and ankylosing spondylitis (AS). BIMZELX, a dual inhibitor targeting IL-17A and IL-17F, demonstrated long-term inflammation control and robust efficacy in managing PsA and axSpA-chronic inflammatory conditions that significantly affect patients' physical and emotional health.

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In April 2025, A recent 3-year interim analysis from the SERENA study offers valuable insights into the safety, effectiveness, and treatment retention of secukinumab in managing psoriatic arthritis (PsA) and ankylosing spondylitis (AS). SERENA, a completed multinational, longitudinal, observational study, evaluated the long-term use, efficacy, and safety of secukinumab in patients with moderate-to-severe plaque psoriasis, active PsA, or active AS. The study included individuals diagnosed with these conditions who had been on commercially available secukinumab for at least 16 weeks prior to enrollment.

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In February 2025, UCB Canada Inc. has successfully concluded negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for BIMZELX Registered (bimekizumab), following positive reimbursement recommendations from both Canada's Drug Agency (CDA) and Quebec's Institut National d'Excellence en Sante et en Services Sociaux (INESSS). These endorsements pertain to the treatment of adults with active psoriatic arthritis (PsA) and ankylosing spondylitis (AS). BIMZELX Registered is the first and only biologic approved in Canada that inhibits both IL-17A and IL-17F. Health Canada authorized its use for active PsA on February 23, 2024, and for axial spondyloarthritis, including AS, on March 11, 2024. The recent successful negotiations with pCPA are anticipated to facilitate public reimbursement, enhancing patient access to this innovative therapy.

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In January 2025, Screening is currently underway for adults with active axial spondyloarthritis (axSpA), including ankylosing spondylitis, for a Phase 2 clinical trial in Germany testing sonelokimab. This nanobody, developed by Moonlake Immunotherapeutics, is being evaluated for its potential in treating inflammatory diseases of the skin and joints. The open-label study, named S-OLARIS (EudraCT 2024-513498-36), aims to assess the efficacy of sonelokimab in reducing inflammation in the spine and sacroiliac joints, which connect the spine to the pelvis. The trial plans to enroll approximately 25 patients, all of whom will receive a 60 mg dose of sonelokimab via subcutaneous injection.

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In December 2024, Neuron23 Registered Inc., a clinical-stage biotechnology company dedicated to precision medicines for genetically defined neurological and immunological diseases, announced the commencement of dosing in a Phase 1 clinical trial of NEU-111 in healthy volunteers. NEU-111 is a highly selective oral allosteric inhibitor of tyrosine kinase 2 (TYK2), a member of the JAK protein family involved in pathological immune signaling. With best-in-class potential, NEU-111 reduces signaling through multiple cytokine receptors, including those for interleukin (IL)-12, IL-23, and interferon (IFN). TYK2 is associated with various immune-mediated inflammatory diseases, including ankylosing spondylitis.

Ankylosing Spondylitis Overview

Ankylosing Spondylitis is a chronic inflammatory disease that primarily affects the spine and sacroiliac joints, causing pain, stiffness, and reduced mobility. Over time, it can lead to the fusion of spinal vertebrae, resulting in a rigid spine. AS is an autoimmune condition, often linked to the HLA-B27 gene, and typically begins in early adulthood.

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Emerging Ankylosing Spondylitis Drugs Under Different Phases of Clinical Development Include:

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KIN-1901: Kinevant Sciences

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Sonelokimab: MoonLake Immunotherapeutics

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QX 002N: Qyuns Therapeutics

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SHR-1314: Suzhou Zelgen Biopharmaceuticals

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SHR0302: Jiangsu HengRui MedicIne

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Jaktinib: Suzhou Zelgen Biopharmaceuticals

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Apremilast: Amgen

Ankylosing Spondylitis Route of Administration

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

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Oral

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Intravenous

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Subcutaneous

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Intramuscular

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Topical.

Ankylosing Spondylitis Molecule Type

Ankylosing Spondylitis Products have been categorized under various Molecule types, such as

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Recombinant fusion proteins

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Small molecule

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Monoclonal antibody

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Peptide

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Polymer

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Gene therapy

Ankylosing Spondylitis Pipeline Therapeutics Assessment

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Ankylosing Spondylitis Assessment by Product Type

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Ankylosing Spondylitis By Stage and Product Type

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Ankylosing Spondylitis Assessment by Route of Administration

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Ankylosing Spondylitis By Stage and Route of Administration

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Ankylosing Spondylitis Assessment by Molecule Type

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Ankylosing Spondylitis by Stage and Molecule Type

DelveInsight's Ankylosing Spondylitis Report covers around 20+ products under different phases of clinical development like

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Late-stage products (Phase III)

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Mid-stage products (Phase II)

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Early-stage product (Phase I)

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Pre-clinical and Discovery stage candidates

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Discontinued & Inactive candidates

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Route of Administration

Further Ankylosing Spondylitis product details are provided in the report. Download the Ankylosing Spondylitis pipeline report to learn more about the emerging Ankylosing Spondylitis therapies [https://www.delveinsight.com/sample-request/ankylosing-spondylitis-bekhterevs-disease-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Some of the key companies in the Ankylosing Spondylitis Therapeutics Market include:

Key companies developing therapies for Ankylosing Spondylitis are - Pfizer, UCB Biopharma, Fresenius Kabi, Shanghai Henlius Biotech, Fujifilm Kyowa Kirin Biologics, Hetero Biopharma, Bio-Thera Solutions, Amgen, CinnaGen, Zydus cadilla, Cadila Pharmaceuticals, Sandoz, Innovent Biologics, Torrent Pharmaceuticals, Cipla, Emcure Pharmaceuticals, Biogen, Boehringer Ingelheim, Zhejiang Hisun Pharmaceuticals, Biocad, AbbVie, Mycenax Biotech, Celltrion, Gilead Sciences, Amgen, Sun Pharma Global, Jiangsu HengRui Medicine Co., Ltd., Izana Bioscience, Suzhou Zelgen Biopharmaceuticals, Iltoo Pharma, Kinevant Sciences, Qyuns Therapeutics, Akeso Biopharma, Nimbus Therapeutics, Enzene Biosciences, Xbrane Biopharma, Dice molecules, and others.

Ankylosing Spondylitis Pipeline Analysis:

The Ankylosing Spondylitis pipeline report provides insights into

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The report provides detailed insights about companies that are developing therapies for the treatment of Ankylosing Spondylitis with aggregate therapies developed by each company for the same.

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It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Ankylosing Spondylitis Treatment.

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Ankylosing Spondylitis key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

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Ankylosing Spondylitis 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.

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Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Ankylosing Spondylitis 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.

Download Sample PDF Report to know more about Ankylosing Spondylitis drugs and therapies [https://www.delveinsight.com/sample-request/ankylosing-spondylitis-bekhterevs-disease-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Ankylosing Spondylitis Pipeline Market Drivers

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Rising prevalence of ankylosing spondylitis, increase in Drug Development for Ankylosing spondylitis are some of the important factors that are fueling the Ankylosing Spondylitis Market.

Ankylosing Spondylitis Pipeline Market Barriers

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However, lack of early diagnosis of the disease, minimum participation of patients in physical activity - High treatment cost and lack of caregiver and other factors are creating obstacles in the Ankylosing Spondylitis Market growth.

Scope of Ankylosing Spondylitis Pipeline Drug Insight

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Coverage: Global

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Key Ankylosing Spondylitis Companies: Kinevant Sciences, MoonLake Immunotherapeutics, Qyuns Therapeutics, Suzhou Zelgen Biopharmaceuticals, Jiangsu HengRui MedicIne, Suzhou Zelgen Biopharmaceuticals, Amgen, and others

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Key Ankylosing Spondylitis Therapies: KIN-1901, Sonelokimab, QX 002N, SHR-1314, SHR0302, Jaktinib, Apremilast, and others

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Ankylosing Spondylitis Therapeutic Assessment: Ankylosing Spondylitis current marketed and Ankylosing Spondylitis emerging therapies

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Ankylosing Spondylitis Market Dynamics: Ankylosing Spondylitis market drivers and Ankylosing Spondylitis market barriers

Request for Sample PDF Report for Ankylosing Spondylitis Pipeline Assessment and clinical trials [https://www.delveinsight.com/sample-request/ankylosing-spondylitis-bekhterevs-disease-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Table of Contents

1. Ankylosing Spondylitis Report Introduction

2. Ankylosing Spondylitis Executive Summary

3. Ankylosing Spondylitis Overview

4. Ankylosing Spondylitis- Analytical Perspective In-depth Commercial Assessment

5. Ankylosing Spondylitis Pipeline Therapeutics

6. Ankylosing Spondylitis Late Stage Products (Phase II/III)

7. Ankylosing Spondylitis Mid Stage Products (Phase II)

8. Ankylosing Spondylitis Early Stage Products (Phase I)

9. Ankylosing Spondylitis Preclinical Stage Products

10. Ankylosing Spondylitis Therapeutics Assessment

11. Ankylosing Spondylitis Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Ankylosing Spondylitis Key Companies

14. Ankylosing Spondylitis Key Products

15. Ankylosing Spondylitis Unmet Needs

16 . Ankylosing Spondylitis Market Drivers and Barriers

17. Ankylosing Spondylitis Future Perspectives and Conclusion

18. Ankylosing Spondylitis Analyst Views

19. Appendix

20. About DelveInsight

About DelveInsight

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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