QYUNS-B (02509) announced that on October 27, 2025, the Phase III clinical trial results of its self-developed drug, QX002N (Lusekizumab), for the treatment of ankylosing spondylitis (AS) were presented as an oral report at the 2025 American College of Rheumatology (ACR) Annual Meeting in Chicago, USA.

The study, led by Professor Zeng Xiaofeng from the Department of Rheumatology and Immunology at Peking Union Medical College Hospital, was a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial. It included a 48-week treatment period (16-week double-blind phase and 32-week open-label phase) and a 4-week safety follow-up, covering 58 research centers in China. A total of 641 patients were randomly assigned in a 1:1 ratio to either the 160mg Lusekizumab group or the placebo group (subcutaneous administration, every four weeks, Q4W).

The primary endpoint was the proportion of patients achieving ASAS40 response at Week 16. Results showed that the ASAS40 response rate in the Lusekizumab group was 40.4%, significantly higher than the placebo group's 18.9% (P<0.0001). Additionally, the ASAS20 response rate in the Lusekizumab group was 65.2%, also significantly higher than the placebo group (P<0.0001), indicating that Lusekizumab effectively alleviates symptoms and signs of AS across multiple dimensions, including pain and spinal function.

Beyond clinical symptoms and functional improvements, the study also evaluated spinal and sacroiliac joint inflammation using magnetic resonance imaging (MRI). The Spondyloarthritis Research Consortium of Canada (SPARCC) score, an MRI-based metric, visually demonstrated spinal and sacroiliac joint edema, objectively reflecting disease activity. At Week 16, the Lusekizumab group showed a mean change from baseline in spinal SPARCC score of -8.1 and -6.2 in sacroiliac joint score, both significantly better than the placebo group's -1.4 and -2.3, respectively. These results provide objective imaging evidence that Lusekizumab effectively reduces spinal and sacroiliac joint inflammation.

In terms of safety, the incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in the Lusekizumab group was similar to the placebo group at Week 16, with most TEAEs being mild to moderate, indicating a favorable overall safety profile.

With its superior clinical efficacy and clear imaging evidence, Lusekizumab is poised to become a new treatment option for AS patients. The company will accelerate the drug's registration and approval process to bring it to market as soon as possible.