QYUNS-B (02509) announced that the New Drug Application for its self-developed Lusekizumab injection (an anti-IL-17A monoclonal antibody, R&D code: QX002N) was accepted by the National Medical Products Administration on March 9, 2026. The submission is supported by a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial (Registration No.: CTR20232574). The clinical study results were presented as an oral report at the American College of Rheumatology Annual Meeting (ACR Convergence) in October 2025. Findings demonstrated that Lusekizumab provided significant and sustained improvements in disease activity, signs, and symptoms in subjects with active AS who had an inadequate response or contraindications to nonsteroidal anti-inflammatory drugs. The drug also exhibited favorable safety and tolerability profiles throughout the 52-week treatment and follow-up period. In the tumor necrosis factor inhibitor-treated population, the drug's efficacy was similarly notable. Additionally, Lusekizumab effectively alleviated edema and inflammation in the spine and sacroiliac joints of subjects, providing clear objective imaging evidence of the drug's ability to suppress disease activity. Lusekizumab is the company's first innovative drug to have its NDA accepted and the second biologic drug, following Sèlexìn®, to reach the NDA stage, marking a progressive entry into the harvest phase of the company's R&D pipeline.