LIVZON PHARMA (01513): The application for market approval of Lecanikta monoclonal antibody injection has been accepted by the National Medical Products Administration.

LIVZON PHARMA (01513) announced that recently, its holding subsidiary Zhuhai Lizhu Monoclonal Antibody Biotechnology Co., Ltd. received the "Acceptance Notice" (Acceptance No.: CXSS2600087) issued by the National Medical Products Administration. The domestic production drug registration and listing application for "Lekcanqi Ta Monoclonal Antibody Injection" jointly developed by Lizhu Monoclonal Antibody and Beijing Xinkanghe Biomedical Technology Co., Ltd. has been officially accepted by the National Medical Products Administration. Ankylosing spondylitis is a chronic inflammatory rheumatic immune disease, with an estimated 4 million patients in China. IL-17 pathway is an important therapeutic target in this field. The application for the listing of Lekcanqi Ta Monoclonal Antibody Injection for the treatment of ankylosing spondylitis has been officially accepted by the National Medical Products Administration. This is the second indication to be accepted after the drug's application for treating psoriasis was prioritized for review. The application for listing is based on key registration phase III clinical trials, conducted as a multicenter, randomized, double-blind, placebo-controlled trial. The results show that the drug is effective and has multiple advantages: it works quickly, with efficacy differences evident as early as the first week, rapidly improving patients' inflammatory indicators; at 16 weeks, the clinical response rate is significantly better than the placebo group, achieving deep symptom remission; the efficacy remains stable up to 52 weeks of follow-up, with switch patients also benefiting significantly and improving their quality of life. The drug is administered by subcutaneous injection every 4 weeks, making it convenient and promoting compliance; it has good safety and tolerability, with a similar rate of adverse events to the placebo group and no new safety signals. Additionally, the drug can be used in both TNFi-naive and TNFi-experienced populations, providing stable and consistent treatment benefits regardless of patients' previous TNFi treatment history. The drug was jointly developed by Lizhu Monoclonal Antibody and Beijing Xinkanghe. As of the date of this announcement, the cumulative R&D investment directly allocated to Lekcanqi Ta Monoclonal Antibody Injection is approximately RMB 216.93 million.