vunakizumab (SHR-1314) / Jiangsu Hengrui Pharma - LARVOL DELTA

"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

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) - No abstract available

Clinical • P2/3 data • Retrospective data • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Vunakizumab Therapeutic Response in Ankylosing Spondylitis: Insights from BMI-Based Subgroup Analysis (EULAR 2025) - No abstract available

Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

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

A Basket Trial of Vunakizumab in Inflammatory Skin Diseases (clinicaltrials.gov) - P=N/A | N=10000 | Not yet recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

New trial • Dermatology • Immunology • Inflammation • Psoriasis

Evaluate the effectiveness and safety of Vunakizumab and Secukinumab in moderate to severe plaque psoriasis: a prospective multi-center randomized controlled clinical trial (ChiCTR) - P4 | N=296 | Sponsor: The Second Affiliated Hospital of Xi'an Jiaotong University; The Second Affiliated Hospital of Xi'an Jiaotong University

New P4 trial • Dermatology • Immunology • Psoriasis

Phase IV Study: Vunakizumab Efficacy and Safety in Moderate-to-severe Plaque Psoriasis (clinicaltrials.gov) - P4 | N=1564 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P4 trial • Dermatology • Immunology • Psoriasis

V SPA: Vunakizumab in Adults with Spondyloarthritis (clinicaltrials.gov) - P4 | N=880 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P4 trial • Ankylosing Spondylitis • Immunology • Seronegative Spondyloarthropathies • Spondylarthritis

V-MIRACLE: A Registry Study Assessing PRO, Dosing Patterns, and Safety of Vunakizumab in Patients With General Rheumatic Diseases. (clinicaltrials.gov) - P=N/A | N=10000 | Not yet recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

New trial • Ankylosing Spondylitis • Giant Cell Arteritis • Idiopathic Arthritis • Immunology • Inflammatory Arthritis • Musculoskeletal Pain • Pain • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Vasculitis

Efficacy and Safety of SHR-1314 by Subcutaneous Injection in Active Moderate to Severe Graves' Orbitopathy Patients (clinicaltrials.gov) - P2 | N=7 | Terminated | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | N=18 ➔ 7 | Not yet recruiting ➔ Terminated; Sponsor commercial considerations

Enrollment change • Trial termination • Thyroid Eye Disease

Study of the Effectiveness and Safety of SHR-1314 for Psoriatic Arthritis (clinicaltrials.gov) - P2 | N=112 | Completed | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Jan 2023 ➔ Jun 2024 | Trial primary completion date: Jan 2023 ➔ Jun 2024

Trial completion • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

2024 ACR Oral Report | Hengrui's innovative drug Vunakizumab for the treatment of active psoriatic arthritis study results announced [Google translate] (Jiangsu Hengrui Press Release) - P2 | N=NA | "The 2024 American College of Rheumatology (ACR) Annual Meeting was held in Washington, D.C. from November 14 to 19. During the meeting...led by Professor Zou Hejian of Huashan Hospital Affiliated to Fudan University were presented in an oral presentation (Abstract No.: 2581) . The results of the study showed that vunakizumab significantly improved the symptoms and signs of patients with psoriatic arthritis (PsA) compared with placebo at week 12, with good safety and tolerability, and is expected to provide a new treatment option for patients with active psoriatic arthritis."

P2 data • Immunology • Psoriatic Arthritis

Vunakizumab in Patients with Active Psoriatic Arthritis: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study (ACR Convergence 2024) - P2 | "Vunakizumab demonstrated superior efficacy to placebo and was well tolerated with an acceptable safety profile in patients with active PsA."

Clinical • P2 data • Dermatology • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • Solid Tumor • CRP • IL17A

Prospective Clinical Trial to Evaluate the Efficacy and Safety of Vunakizumab in Adults With Moderate-to-severe Plaque Psoriasis Who Have Not Previously Received Biologics (clinicaltrials.gov) - P=N/A | N=1516 | Not yet recruiting | Sponsor: First Hospital of China Medical University

New trial • Dermatology • Immunology • Psoriasis