LIVZON PHARMA's Application for New Antibody Drug Receives Regulatory Acceptance

LIVZON PHARMA (HKEX: 01513) has announced that its application for the marketing authorization of a new drug has been accepted by China's National Medical Products Administration.

The application for the domestic production and registration of "Laikangqita Monoclonal Antibody Injection" was submitted by Zhuhai Livzon Mabpharm Inc., a subsidiary of the group, in collaboration with Beijing Xinkanghe Biopharmaceutical Co., Ltd.

The drug targets ankylosing spondylitis, a chronic inflammatory rheumatic immune disease affecting approximately 4 million patients in China. The IL-17 pathway is a significant therapeutic target in this field.

This acceptance for the ankylosing spondylitis indication marks the second accepted application for the drug, following a prior acceptance and inclusion in a priority review for a psoriasis indication.

The application is based on a pivotal Phase III clinical study, which was a multicenter, randomized, double-blind, placebo-controlled trial.

Study results demonstrated the drug's clear and robust efficacy, showing multiple advantages. It exhibited a rapid onset of action, with efficacy differences appearing as early as the first week, quickly improving patients' inflammatory markers.

Clinical response rates at week 16 were significantly better than the placebo group, achieving deep symptom relief. Efficacy remained stable through 52 weeks of follow-up, with benefits also observed in patients who switched treatments, alongside improvements in quality of life.

The drug utilizes a convenient subcutaneous injection regimen administered every four weeks, which aids in treatment compliance.

Its safety and tolerability profile is favorable, with adverse event rates similar to the placebo group and no new safety signals identified.

Furthermore, the drug is effective for both TNF inhibitor-naïve and TNF inhibitor-experienced patient populations, providing stable and consistent therapeutic benefits regardless of prior treatment history.

The drug was jointly developed by Livzon Mabpharm and Beijing Xinkanghe. As of the announcement date, the cumulative direct research and development investment for Laikangqita Monoclonal Antibody Injection amounts to approximately RMB 216.93 million.