Jinlixi (xeligekimab) / Zhixiang (Shanghai) Pharma - LARVOL DELTA

Xeligekimab, an Interleukin-17A Antagonist for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 48-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study. (PubMed, BioDrugs) - P3 | "Xeligekimab demonstrated significant efficacy in improving the signs and symptoms of active r-axSpA in Chinese patients at week 16, with sustained effects observed through week 48 and no new safety signals identified."

Clinical • Journal • P3 data • Ankylosing Spondylitis • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

Efficacy and Safety of Biologics to Treat Adults With Active Radiographic Axial Spondyloarthritis: Systematic Review and Bayesian Network Meta-Analysis (ISPOR-EU 2025) - "OBJECTIVES: To compare efficacy and safety of IL-17 inhibitors in the treatment of adults with active radiographic axial spondyloarthritis (r-AxSpA) over a 16-week period using network meta-analysis (NMA). We conducted systematic literature search in PubMed and Embase in November 2024 to retrieve publications with results of randomized controlled trials (RCTs) evaluating efficacy and safety of IL-17 inhibitors (netakimab, secukinumab, ixekizumab, bimekizumab, brodalumab, xeligekimab, vunakizumab) in adults with active r-AxSpA... Netakimab showed the highest relative efficacy among available IL-17 inhibitors used to treat adults with active r-AxSpA over 16-week horizon and demonstrated a favorable safety profile."

Retrospective data • Review • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

A case report of plaque psoriasis comorbid with hidradenitis suppurativa, hepatitis B, and colorectal cancer treated with xeligekimab. (PubMed, Front Immunol) - "Previous treatment with topical corticosteroids, Calcipotriol Betamethasone Ointment and acitretin provided poor control of psoriasis, resulting in significant quality-of-life impairment. Xeligekimab demonstrated significant efficacy and acceptable safety over 28 weeks in this complex case of psoriasis with concurrent hidradenitis suppurativa, chronic hepatitis B, and metastatic colorectal cancer. Extended follow-up is ongoing to evaluate long-term outcomes, while larger prospective studies are warranted to validate biologic therapy for such multimorbid presentations."

Journal • Colorectal Cancer • Dermatology • Hepatitis B • Hidradenitis Suppurativa • Immunology • Infectious Disease • Oncology • Psoriasis • Solid Tumor • IL17A

Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. (PubMed, Cochrane Database Syst Rev) - "Our review shows that, compared to placebo, the biologics infliximab, xeligekimab, bimekizumab, ixekizumab, and risankizumab were the most effective treatments for achieving PASI 90 in people with moderate-to-severe psoriasis, with high-certainty evidence for bimekizumab and moderate-certainty evidence for infliximab, xeligekimab, ixekizumab, and risankizumab. This network meta-analysis evidence is limited to induction therapy (outcomes measured from 8 to 24 weeks after randomisation), and is not sufficient for evaluating longer-term outcomes in this chronic disease. Moreover, we found low numbers of studies for some of the interventions, and the young age (mean 44.4 years) and high level of disease severity (PASI 20.5 at baseline) may not be typical of people seen in daily clinical practice. More randomised trials directly comparing active agents are needed, and these should include systematic subgroup analyses (sex, age, ethnicity, comorbidities, psoriatic arthritis)...."

Clinical • Journal • Retrospective data • Review • Dermatology • Immunology • Inflammatory Arthritis • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL12A • IL17A

Efficacy of Xeligekimab in Chinese Patients with Moderate-to-Severe Plaque Psoriasis Previously Treated with TNFi: A Post-hoc Analysis of a Phase III Study (EADV 2025) - P3 | "Xeligekimab demonstrated rapid and sustained skin clearance in Chinese patients with moderate-to- severe plaque psoriasis who had previously been treated with TNFi. It showed a rapid onset of action at week 12 and maintained its efficacy stably over 52 weeks. These results support xeligekimabas an effective treatment option for Chinese patients with moderate-to-severe psoriasis who have previously received TNFi treatment."

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

Efficacy of xeligekimab in patients with moderate-to-severe plaque psoriasis:a post hoc analyis of a randomized,phase 3 trial (EADV 2025) - "The post hoc analyis demonstrated improvement in IL-17A inhibitor treating moderate-to-severe plaque psoriasis and the improvement was remarkable, whether previous exposure to systemic treatment ('yes' or 'no') at baseline. * P < 0.05**P < 0.01 Figur 1 PASI 75/90/100 response and PGA 0/1 response outcomes at week 12 and over time through to week 52"

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

Efficacy and safety of Xeligekimab in patients with moderate-to-severe plaque psoriasis with cardiovascular and/or metabolic comorbidities: a post-hoc analysis of a phase 3 trial (EADV 2025) - "In this post-hoc analysis, Xeligekimab demonstrated a rapid onset of action, high rates of skin clearance in patients with moderate-to-severe plaque psoriasis with cardiovascular and/or metabolic comorbidities, sustaining efficacy for up to 52 weeks. Safety findings in this patient population were consistent with other same-target drugs; no special risk signals were found for Xeligekimab. This data highlights the benefits of Xeligekimab as an alternative biologic medication in this subgroup."

Clinical • P3 data • Retrospective data • Cardiovascular • Dermatology • Immunology • Metabolic Disorders • Psoriasis

Super-responders to Xeligekimab in Chinese Patients with Moderate-to-severe Plaque Psoriasis: Clinical Characteristics and Long-term Efficacy in a Post-hoc Analysis of a Phase III Trial (EADV 2025) - P3 | "This study indicates that Xeligekimab achieved a 41.11% (178/433) super-response rate at week 12. Shorter disease duration, lower baseline PASI, and larger BSA were independently associated with super-response. Super-responders had better long-term efficacy outcomes."

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

Super responders to xeligekimab in Chinese patients with moderate-to-severe plaque psoriasis: clinical characteristics and long-term efficacy in a post hoc analysis of a phase III trial [WITHDRAWN] [WITHDRAWN] (EADV 2025) - No abstract available

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

Correction: Investigation of the Efficacy and Safety of Xeligekimab (GR1501) in Patients with Moderate-to-Severe Plaque Psoriasis: A Multicenter, Randomized, Double-Blind Phase II Clinical trial. (PubMed, Dermatol Ther (Heidelb)) - No abstract available

Clinical • P2 data • Dermatology • Immunology • Psoriasis

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE II CLINICAL TRIAL TO EVALUATE THE PRELIMINARY EFFICACY, SAFETY OF REPEATED ADMINISTRATION OF XELIGEKIMAB (GR1501) INJECTION IN PATIENTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (EULAR 2025) - P2 | "Xeligekimab (GR1501) 100~300mg group showed great efficacy and safety in patients with moderate to severe axial spondyloarthritis, but compared with the 100mg group and the 200mg group, the overall incidence of adverse events in the 300mg dose group was higher, so 100mg and 200mg were to be chosen for Xeligekimab (GR1501) phase III study."

Clinical • P2 data • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

Efficacy and Safety of Xeligekimab in Radiographic Axial Spondyloarthritis: Results from a Phase 3 Trial (EULAR 2025) - "Xeligekimab showed significant efficacy in alleviating the clinical manifestations of active r-axSpA in Chinese patients at week 16, with sustained improvements observed through week 48 and no new safety concerns identified. Schematic overview of the study cohort. Screening Phase (Week -4 to Week 0): Patients were screened for eligibility before randomization."

Clinical • P3 data • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Seronegative Spondyloarthropathies • Spondylarthritis • CRP • IL17A

Investigation of the Efficacy and Safety of Xeligekimab (GR1501) in Patients with Moderate-to-Severe Plaque Psoriasis: A Multicenter, Randomized, Double-Blind Phase II Clinical. (PubMed, Dermatol Ther (Heidelb)) - P1 | "Xeligekimab demonstrated strong efficacy, sustained response, and favorable safety in patients with moderate-to-severe plaque psoriasis."

Clinical • Journal • P2 data • Dermatology • Immunology • Inflammation • Psoriasis • IL17A

Recurrence rate in patients with moderate to severe Hidradenitis Suppurativa treated with Xeligekimab: a multicenter, prospective, observational clinical study (ChiCTR) - P=N/A | N=74 | Not yet recruiting | Sponsor: Peking University Third Hospital; Peking University Third Hospital

New trial • Dermatology • Hidradenitis Suppurativa • Immunology

Efficacy and safety of Xeligekimab in the treatment of Hidradenitis Suppurativa: a multicenter, randomized, double-blind, placebo-controlled clinical trial (ChiCTR) - P4 | N=74 | Not yet recruiting | Sponsor: Department of Dermatology, Peking University Third Hospital; Peking University Third Hospital

New P4 trial • Dermatology • Hidradenitis Suppurativa • Immunology • IL17A

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

Real-World Study of Xeligekimab for Moderate to Severe Plaque Psoriasis(XP-Real) (clinicaltrials.gov) - P=N/A | N=1000 | Not yet recruiting | Sponsor: Chongqing Genrix Biopharmaceutical Co., Ltd

New trial • Real-world evidence • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Xeligekimab: First Approval. (PubMed, Drugs) - "Xeligekimab is under regulatory review in China for the treatment of axial spondyloarthritis and is undergoing phase II development for the treatment of lupus nephritis. This article summarizes the milestones in the development of xeligekimab leading to this first approval for plaque psoriasis."

Journal • Review • Ankylosing Spondylitis • Dermatology • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Psoriasis • Seronegative Spondyloarthropathies • Spondylarthritis • CXCL1 • IL17A • IL6

Study of Efficacy and Safety of GR1501 in Patients with Radiographic Axial Spondyloarthritis (clinicaltrials.gov) - P3 | N=465 | Completed | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Apr 2025 ➔ May 2024 | Trial primary completion date: Nov 2024 ➔ Dec 2023

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

China’s Hengrui & Genrix Launch Two Anti-IL-17A antibodies (NAVLIN DAILY) - "Two China-based companies Jiangsu Hengrui Medicine Co., Ltd and Chongqing Genrix Bio Pharmaceutical Co., Ltd have launched self-developed anti-IL-17A antibodies on the Chinese market. The products, vunakizumab by Jiangsu Hengrui and xeligekimab by Chongqing Genrix, are the first domestically developed anti-IL-17A antibodies to reach China. The drugs were both approved in the country last month for the treatment of moderate to severe plaque psoriasis."

China approval • Psoriasis

Population Pharmacokinetics of Xeligekimab: An Anti-IL-17A Monoclonal Antibody, in Patients with Moderate to Severe Plaque Psoriasis. (PubMed, J Clin Pharmacol) - "Vc/F was significantly influenced by body weight, age, gender, and baseline albumin. However, the clinical relevance of these covariate effects on exposure parameters was determined to be limited."

Journal • PK/PD data • Dermatology • Immunology • Psoriasis • IL17A

A multicenter, randomized, double-blinded, placebo-controlled, phase Ⅲ study evaluating the efficacy and safety of Xeligekimab (GR1501) in patients with moderate-to-severe plaque psoriasis. (PubMed, Br J Dermatol) - "Xeligekimab showed high efficacy and is well tolerated in Chinese patients with moderate-to-severe plaque psoriasis."

Clinical • Journal • Dermatology • Immunology • Psoriasis • IL17A

A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis. (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Zheng Liu ENT

New P2 trial • Allergic Rhinitis • Immunology • Inflammation

The first in China! Zhixiang Jintai anti-IL-17A monoclonal antibody application for listing [Google translation] (Stockstar) - "...the CDE official website showed that Chongqing Zhixiang Jintai xeligekimab Injection’s marketing application was accepted by the State Food and Drug Administration, and it was the first domestic anti-IL-17A monoclonal antibody to apply for listing."

Non-US regulatory • Immunology • Musculoskeletal Diseases • Psoriasis • Spondylarthritis

Study of Efficacy and Safety of GR1501 in Patients With Radiographic Axial Spondyloarthritis (clinicaltrials.gov) - P3 | N=465 | Active, not recruiting | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

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