Joincare(SH:600380) news flash·2025-07-21 10:48Core Viewpoint - The phase III clinical trial of LZM012, a recombinant human IL-17A/F humanized monoclonal antibody injection developed by Zhuhai Lizhu Biotech Co., Ltd. and Beijing Xinkanghe Biopharmaceutical Technology Co., Ltd., has achieved its primary endpoint in patients with moderate to severe plaque psoriasis [1] Group 1: Clinical Trial Results - The trial was a multicenter, randomized, double-blind, positive-controlled study comparing LZM012 to the control group, Secukinumab [1] - At week 12, the PASI 100 response rate for LZM012 was 49.5%, compared to 40.2% for Secukinumab, indicating non-inferiority and superiority of LZM012 [1] - The PASI 75 response rate at week 4 was 65.7% for LZM012 versus 50.3% for Secukinumab, demonstrating a faster onset of action for LZM012 [1] - At week 52, the PASI 100 response rates for LZM012 in the 320mg Q4W and 320mg Q8W maintenance treatment groups were 75.9% and 62.6%, respectively, showing sustained benefits for psoriasis patients [1] Group 2: Safety and Regulatory Progress - The overall safety profile of LZM012 was good, with the incidence of common adverse events comparable to that of the control group [1] - Lizhu Group has submitted a communication application to the National Medical Products Administration (NMPA) for the marketing authorization of LZM012 for the treatment of adult patients with moderate to severe plaque psoriasis, advancing the drug's approval process [1]