lecankitug (XKH004) / Kanova Biopharma, Livzon Pharma - LARVOL DELTA

Novel dual-target IL-17A/F monoclonal antibody XKH004 shows 52-week efficacy and safety in active ankylosing spondylitis in phase 3 trial (Eurekalert) - "This large-scale long-term clinical study confirms that the independently developed dual-target antibody XKH004 can effectively and stably improve various symptoms and physical functions of patients with active ankylosing spondylitis over 52 weeks of treatment. Compared with placebo treatment, XKH004 significantly increases the proportion of patients achieving standard clinical remission. It not only quickly relieves back pain and morning stiffness, but also continuously reduces systemic inflammation, improves spinal mobility and patients’ daily living ability."

P3 data • Ankylosing Spondylitis • Immunology

Livzon Pharmaceutical’s Lecankitug Wins NMPA Approval for Moderate-to-Severe Plaque Psoriasis (flcube.com) - "Lecankitug completed a Phase III clinical trial in moderate-to-severe plaque psoriasis with secukinumab as the positive control. Data demonstrated that lecankitug was superior to the control group in terms of onset of action, skin lesion clearance rate, and long-term efficacy, with a safety profile comparable to that of the control group — a head-to-head result that provides a direct evidence base for switching or initiating on the dual IL-17A/F mechanism."

China approval • Immunology • Plaque Psoriasis

A Study to Evaluate the Efficacy and Safety of LZM012 ( Psoriasis ) (clinicaltrials.gov) - P3 | N=244 | Completed | Sponsor: Livzon Pharmaceutical Group Inc.

New P3 trial • Dermatology • Immunology • Psoriasis

Marketing Authorization Application for Lecankitug Injection Accepted for Review by China’s National Medical Products Administration (HKEXnews) - "Proposed indication (or main treatments):for adult patients with active ankylosing spondylitis (AS, radiographic axial spondyloarthritis) with inadequate response or intolerance to conventional therapy....The NDA is supported by a pivotal Phase III registrational clinical study, which is a multi-center, randomized, double-blind, placebo-controlled trial."

China filing • Ankylosing Spondylitis

Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection in the Treatment of Moderate-to-Severe Active AS (clinicaltrials.gov) - P3 | N=323 | Completed | Sponsor: Zhejiang Kanova Biopharmaceutical Co., LTD

New P3 trial • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Marketing Authorization Application for Lecankitug injection accepted for review by China's National Medical Products Administration (HKEXnews)

China filing • Psoriasis

Biologics and Small Molecules for Psoriasis in China: Global Integration and Domestic Innovation (EADV 2025) - " Biosimilars: Domestic TNF-α inhibitors (e.g., Yisaipu) reduced costs by 50–60%, increasing systemic therapy uptake. Innovative Biologics: IL-17A inhibitors (frunevetmab, sailizumab [Phase III PASI75: 90.7%]) and IL-23- targeted piconchizumab (NDA 2024) demonstrated non-inferiority to global counterparts (secukinumab, guselkumab). Small Molecules: Local JAK1 (ivarmacitinib [NDA filed]) and TYK2 inhibitors (D-2570 [Phase II]) showed comparable efficacy/safety to upadacitinib and deucravacitinib. Emerging Therapies: Bispecifics (XKH004 [IL-17A/F]), IL-36R mAb HB0034 (GPP-focused), CRISPR-edited IL- 23/Th17 modulators, and engineered MSCs entered late-stage development... China's psoriasis therapeutics have transitioned from import dependency to globally competitive innovation. Domestic biosimilars and novel agents now challenge foreign dominance, while cost-reduction strategies improve accessibility for 6–8 million patients. With 15+ candidates in global trials, China..."

Clinical • Dermatology • Immunology • Psoriasis • IL17A • IL23A • JAK1 • TYK2

Head-to-head Phase III trial is successful! The first domestically produced IL-17A/F monoclonal antibody is about to be approved for marketing [Google translation] (PhIRDA) - P3 | N=918 | NCT06110676 | Sponsor: Livzon Pharmaceutical Group Inc. | "The primary efficacy endpoint of the study has been achieved . The PASI 100 response rate at week 12 was 49.5% for LZM012 and 40.2% for secukinumab in the control group, showing that LZM012 was non-inferior and superior to secukinumab...The main secondary efficacy endpoint, the PASI 75 response rate at week 4, was 65.7% for LZM012 and 50.3% for the control group with secukinumab, indicating that LZM012 was more effective faster; the PASI 100 response rate at week 52 was 75.9% and 62.6% for the LZM012 320mg Q4W and 320mg Q8W maintenance treatment groups, respectively, indicating that psoriasis patients can benefit sustainably....Based on this, Livzon Group has recently submitted a pre-marketing authorization communication application to the Center for Drug Evaluation (CDE) of the National Medical Products."

China filing • P3 data • Psoriasis

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

Efficacy and Safety of the Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection (XKH004) in Patients with Active Ankylosing Spondylitis: Findings from a 24-Week, Phase 2 Multicenter, Randomized, Placebo-Controlled Study (ACR Convergence 2024) - "Background/Purpose: XKH004, the first recombinant anti-human IL-17A/F humanized monoclonal antibody in China (also known as XKH004), shares the same therapeutic target as Bimekizumab from UCB pharma, the first biologic targeting IL-17 A/F (XKH004 is the second one worldwide). In patients with active AS, various dosages of XKH004 effectively improved disease activity. The safety and tolerability profile were favorable, and no immunogenicity risk was identified for up to 24 weeks."

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

Psoriasis: A Study to Evaluate the Efficacy and Safety of LZM012 (clinicaltrials.gov) - P3 | N=918 | Recruiting | Sponsor: Livzon Pharmaceutical Group Inc.

New P3 trial • Dermatology • Immunology • Psoriasis • Psoriatic Arthritis