Livzon Pharmaceutical Group Inc. has announced positive results from a Phase III clinical trial of LZM012, a novel dual-target monoclonal antibody that demonstrated superior efficacy compared to Secukinumab in treating moderate to severe plaque psoriasis. The recombinant anti-human IL-17A/F humanized monoclonal antibody injection represents the first domestic biopharmaceutical simultaneously targeting both IL-17A and IL-17F cytokines.
Phase III Trial Results Show Superior Efficacy
The multicenter, randomized, double-blind, positive-controlled clinical trial, led by Huashan Hospital affiliated with Fudan University, successfully met its primary endpoint. At week 12, LZM012 achieved a PASI 100 response rate of 49.5% compared to 40.2% for the Secukinumab control group, demonstrating both non-inferiority and superiority to the established treatment.
The trial results revealed LZM012's faster onset of action, with a PASI 75 response rate of 65.7% at week 4 compared to 50.3% for Secukinumab. This rapid therapeutic response represents a significant clinical advantage for patients seeking quick symptom relief.
Sustained Long-Term Benefits
Long-term efficacy data showed sustained benefits for psoriasis patients through 52 weeks of treatment. The PASI 100 response rates for LZM012 maintenance treatment groups were 75.9% for the 320mg Q4W regimen and 62.6% for the 320mg Q8W regimen, indicating durable therapeutic effects with flexible dosing options.
Dual-Target Mechanism Offers Enhanced Therapeutic Approach
LZM012's innovative mechanism involves selective binding to both IL-17A and IL-17F cytokines, blocking their interaction with the IL-17RA/IL-17RC receptor complex. This dual blockade approach can reduce inflammation-related gene and cytokine expression levels more effectively than single IL-17A targeting, while also more effectively inhibiting disease-related immune cell migration.
Safety Profile and Regulatory Progress
The overall safety profile of LZM012 was characterized as good, with common adverse event incidence rates comparable to those observed in the Secukinumab control group. This favorable safety profile supports the drug's potential for clinical use in the target patient population.
Livzon has recently submitted a pre-application for communication regarding marketing authorization to the National Medical Products Administration's Drug Evaluation Center (CDE) for treating adult moderate to severe plaque psoriasis, advancing LZM012's path to market approval.
Competitive Landscape in IL-17 Targeting
The Chinese psoriasis treatment market currently includes several IL-17A single-target antagonists, including Novartis's Secukinumab injection, Eli Lilly's Ixekizumab, and domestic products from Hengrui Pharmaceuticals and Zhixiang Jintai. Multiple domestic companies are actively developing treatments in this therapeutic area, including Sunshine Guojian Pharmaceutical, Shanghai Junshi Biosciences, and Zhejiang Huahai Pharmaceutical.
LZM012 was jointly developed by Livzon's subsidiary Zhuhai Livzon Biologics Co., Ltd. and Beijing Xinkanghe Biomedical Technology Co., Ltd., representing a collaborative approach to advancing innovative psoriasis treatments in the Chinese pharmaceutical market.
