AnDaJing (vunakizumab) / Jiangsu Hengrui Pharma - LARVOL DELTA

A Study on the First-line Treatment of Small Cell Lung Cancer With Adebrelimab and Vunakizumab and Chemotherapy (clinicaltrials.gov) - P2 | N=28 | Not yet recruiting | Sponsor: Fujian Cancer Hospital

New P2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Chinese SLE Treatment And Research Group | Not yet recruiting ➔ Recruiting | Trial completion date: Apr 2027 ➔ Dec 2027 | Trial primary completion date: Oct 2025 ➔ Nov 2026

Enrollment open • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Trial of SHR-1314 Injection in Adult Patients With Active Non-radiographic Axial Spondyloarthritis (clinicaltrials.gov) - P3 | N=380 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Trial completion date: Feb 2028 ➔ Dec 2028 | Trial primary completion date: Apr 2027 ➔ Feb 2028

Trial completion date • Trial primary completion date • Ankylosing Spondylitis • Immunology • Seronegative Spondyloarthropathies • Spondylarthritis

EFFICACY AND SAFETY OF VUNAKIZUMAB ON ENTHESITIS IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS: A POST-HOC ANALYSIS FROM A RANDOMIZED, DOUBLE-BLIND, PHASE 2/3 STUDY (EULAR 2025) - "This post-hoc analysis showed that vunakizumab 120 mg significantly improved enthesitis, as measured by the MASES score, in comparison to placebo at week 16 in patients with active AS. Furthermore, subsequent switching from placebo to vunakizumab also resulted in considerable improvement in enthesitis in this population."

Clinical • P2/3 data • Retrospective data • Ankylosing Spondylitis • Immunology • Infectious Disease • Inflammatory Arthritis • Pain • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • IL17A

EFFECT OF VUNAKIZUMAB ON PATIENT-REPORTED OUTCOMES IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS: RESULTS FROM A RANDOMIZED, DOUBLE-BLIND, PHASE 2/3 STUDY (EULAR 2025) - P2/3 | "Treatment with vunakizumab provides significant and sustained improvements in patient-reported disease activity, functional impairment, health-related quality of life, and pain in patients with active ankylosing spondylitis."

Clinical • P2/3 data • Patient reported outcomes • Ankylosing Spondylitis • Back Pain • Immunology • Inflammatory Arthritis • Musculoskeletal Pain • Pain • Rheumatology • Seronegative Spondyloarthropathies • IL17A

EFFICACY AND SAFETY OF VUNAKIZUMAB IN ANKYLOSING SPONDYLITIS: A SUBGROUP ANALYSIS BY GENDER (EULAR 2025) - P2/3 | "Vunakizumab 120 mg demonstrated statistically significant and clinically meaningful improvements in AS symptoms across both male and female patient populations, with a rapid onset of response observed by week 2. The safety profile was manageable and tolerable. These findings highlight the potential of vunakizumab as an effective treatment option for AS patients, regardless of gender."

Clinical • Ankylosing Spondylitis • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Pain • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

Efficacy and safety of vunakizumab in active ankylosing spondylitis with and without prior TNF-a inhibitor exposure: a post-hoc analysis of a randomized, double-blind, phase 2/3 study (EULAR 2025) - P2/3 | "Vunakizumab showed efficacy and acceptable safety in patients with active AS, regardless of prior TNFi exposure. These findings warrant validation in future studies."

Clinical • P2/3 data • Retrospective data • Ankylosing Spondylitis • Immunology • Infectious Disease • Inflammatory Arthritis • Oncology • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

Vunakizumab Therapeutic Response in Ankylosing Spondylitis: Insights from BMI-Based Subgroup Analysis (EULAR 2025) - P2/3 | "Vunakizumab 120 mg significantly improved AS symptoms across BMI categories, with consistent efficacy and rapid response observed in both subgroups. These results highlight its potential as a valuable treatment option for AS patients, regardless of BMI."

Ankylosing Spondylitis • Immunology • Infectious Disease • Inflammatory Arthritis • Pain • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

Efficacy of Vunakizumab in Erosive haNd osteoarthritiS (VENuS): a Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial (ChiCTR) - P=N/A | N=150 | Not yet recruiting | Sponsor: Shanghai Sixth People's Hospital; Shanghai Sixth People's Hospital

New trial • Immunology • Osteoarthritis • Pain • Rheumatology

First successful treatment of epidermolytic Ichthyosis with Vunakizumab: A Case Report. (PubMed, Front Immunol) - "After a three-month treatment with Vunakizumab, symptoms alleviated significantly and inflammatory factor levels normalized. This not only shows the great potential of Vunakizumab in treating ichthyosis but also paves the way for further research on anti-IL-17A therapies for skin cornification disorders, offering treatment options for ichthyosis patients."

Journal • Atopic Dermatitis • Dermatology • Immunology • Pruritus • Vitiligo • IL17A • KRT1

Phase IV Study: Vunakizumab Efficacy and Safety in Moderate-to-severe Plaque Psoriasis (clinicaltrials.gov) - P=N/A | N=1516 | Recruiting | Sponsor: First Hospital of China Medical University | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

A Trial of SHR-1314 Injection in Adult Patients With Active Non-radiographic Axial Spondyloarthritis (clinicaltrials.gov) - P3 | N=380 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Ankylosing Spondylitis • Immunology • Seronegative Spondyloarthropathies • Spondylarthritis

"New Drug Progress Express" Hengrui IL-17A monoclonal antibody "vunakizumab" has been approved for a new indication (163.com) - "On April 8, 2025, Hengrui Medicine announced that its independently developed Class 1 innovative drug, vunakizumab Injection (R&D code: SHR-1314), has been approved by the National Medical Products Administration (NMPA), with a new indication for adult patients with active ankylosing spondylitis (AS) who have poor efficacy in conventional treatment. This breakthrough not only provides a new treatment option for AS patients, but also marks another important milestone for Hengrui Medicine in the field of autoimmune diseases....The approval was based on a multicenter, randomized, double-blind, placebo-controlled adaptive seamless Phase II/III clinical study (SHR-1314-302)."

China approval • Ankylosing Spondylitis

Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Chinese SLE Treatment And Research Group | Phase classification: P1/2 ➔ P1

Phase classification • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

IL-17 pathway inhibitor Vunakizumab for the treatment of systemic sclerosis: a single arm, open label trial (ChiCTR) - P=N/A | N=5 | Not yet recruiting | Sponsor: The Second Xiangya Hospital, Central South University; The Second Xiangya Hospital, Central South University

New trial • Immunology • Scleroderma • Systemic Sclerosis

Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus (clinicaltrials.gov) - P1/2 | N=20 | Not yet recruiting | Sponsor: Chinese SLE Treatment And Research Group

New P1 trial • New P1/2 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Impact of treatment interruption on the efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis: a post-hoc analysis of a phase 3 trial (AAD 2025) - P3 | "Interrupted vunakizumab treatment reduced the clinical response and quality of life in patients with moderate-to-severe plaque psoriasis."

Clinical • P3 data • Retrospective data • Dermatology • Immunology • Psoriasis • IL17A

Impact of vunakizumab on metabolic parameters and body mass index in moderate-to-severe plaque psoriasis patients with or without comorbidities: a post-hoc analysis of a phase III trial (AAD 2025) - P3 | "Vunakizumab did not affect impact metabolic parameters and BMI in patients with moderate-to-severe plaque psoriasis, regardless of comorbidity status."

Clinical • P3 data • Retrospective data • Cardiovascular • Dermatology • Diabetes • Dyslipidemia • Genetic Disorders • Hypertension • Immunology • Metabolic Disorders • Obesity • Psoriasis

Comparison of patient-reported outcomes in patients achieving complete versus near-complete skin clearance following Vunakizumab treatment: A post-hoc analysis of a phase III trial (AAD 2025) - P3 | "The mean DLQI score and itch NRS score were lower, but the mean SF-36 MCS and SF-36 PCS were higher at some time points in the PASI 100 group than in the PASI 90-99 group (P<0.05). Conclusion Patients with complete skin clearance following Vunakizumab treatment showed improved quality of life, reduced pruritus, and enhanced mental health compared to those with near-complete clearance."

Clinical • P3 data • Patient reported outcomes • Retrospective data • Dermatology • Immunology • Pruritus • Psoriasis

Early response to vunakizumab at week 2 predicts favorable long-term efficacy in patients with moderate-to-severe plaque psoriasis: a post-hoc analysis of a phase III, randomized controlled trial (AAD 2025) - P3 | "Patients with moderate-to-severe plaque psoriasis who achieved early response to vunakizumab at W2 significantly increase the likelihood of improved long-term treatment response."

Clinical • P3 data • Retrospective data • Dermatology • Immunology • Psoriasis • IL17A

Efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis across different regions of China: a post-hoc analysis of a phase III, randomized controlled trial (AAD 2025) - P3 | "The efficacy and safety of vunakizumab are not affected by different regions of China in patients with moderate-to-severe plaque psoriasis."

Clinical • P3 data • Retrospective data • Dermatology • Immunology • Psoriasis • IL17A

A Trial of SHR-1314 Injection in Adult Patients With Active Non-radiographic Axial Spondyloarthritis (clinicaltrials.gov) - P3 | N=380 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P3 trial • Ankylosing Spondylitis • Immunology • Seronegative Spondyloarthropathies • Spondylarthritis

Starting a new phase, 6 drug clinical trial projects of Puyang Oilfield General Hospital successfully passed the project approval [Google translation] (Sohu.com) - "Respiratory Medicine: A multicenter, randomized, double-blind, multiple-dose, dose-escalating, placebo- and positive-controlled Phase IIa clinical study to evaluate the safety, tolerability, and efficacy of TRN-157 nebulizer inhalation in patients with chronic obstructive pulmonary disease (COPD)....Department of Rheumatology and Immunology: A multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of SHR-1314 injection in adult patients with active psoriatic arthritis....Department of Endocrinology: A randomized, double-blind, placebo-controlled Phase IIb clinical study on the efficacy and safety of ABP2111Na tablets in overweight/obese participants."

New P2a trial • Trial status • Chronic Obstructive Pulmonary Disease • Obesity • Psoriatic Arthritis

Next-Generation Anti-IL-17 Agents for Psoriatic Disease: A Pipeline Review. (PubMed, Am J Clin Dermatol) - "Key agents under investigation include netakimab, vunakizumab, xeligekimab, gumokimab, HB0017, CJM 112, JS005, 608, LZM012, ZL-1102, izokibep, sonelokimab, DC-806, DC-853, and LEO 153339. Both preclinical and clinical trial data for each agent are summarized, with an emphasis on their efficacy, adverse effects, immunogenicity, and future outlooks."

Journal • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

The Efficacy and Safety of SHR-1314 in the Treatment of Pediatric Patients of Age 6 to <18 Years With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=90 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P3 trial • Dermatology • Immunology • Pediatrics • Psoriasis