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

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

Efficacy and Safety of Xeligekimab in Radiographic Axial Spondyloarthritis: Results from a Phase 3 Trial (EULAR 2025) - No abstract available

Clinical • P3 data • Ankylosing Spondylitis • Immunology • Seronegative Spondyloarthropathies • Spondylarthritis

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

to Evaluate the Preliminary Efficacy and Safety of GR1501 Injection in Patients With Active Axial Spondyloarthritis (clinicaltrials.gov) - P2 | N=160 | Completed | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed

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