QYUNS-B: The results of the Phase III clinical study of Rusechita monoclonal antibody (QX002N) for ankylosing spondylitis were presented at the 2025 ACR Annual Meeting

According to the Zhitong Finance APP, QYUNS-B (02509) announced that on October 27, 2025, the results of the Phase III clinical study of its independently developed QX002N monoclonal antibody for the treatment of ankylosing spondylitis (AS) will be presented in a verbal report at the 2025 American College of Rheumatology Annual Meeting (ACR Convergence) held in Chicago, USA. This study was led by Professor Zeng Xiaofeng from the Department of Rheumatology and Immunology at Peking Union Medical College Hospital, Chinese Academy of Medical Sciences. It is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study. The study includes a treatment period of 48 weeks (16 weeks of double-blind treatment and 32 weeks of open-label treatment) and a 4-week safety follow-up period, covering 58 research centers in China, with 641 patients randomly assigned in a 1:1 ratio to either the 160mg QX002N group or the placebo group (subcutaneous administration, once every four weeks, Q4W). The primary endpoint of this study is the proportion of ASAS40 responders at week 16. The results showed that at week 16, the ASAS40 response rate in the QX002N group reached 40.4%, significantly higher than the 18.9% in the placebo group (P<0.0001). Additionally, the ASAS20 response rate in the QX002N group was 65.2%, also significantly higher than that of the placebo group (P<0.0001), indicating that QX002N can effectively relieve symptoms and signs of AS patients from multiple dimensions, including pain and spinal function. In addition to improvements in clinical symptoms and spinal function, this study also assessed the inflammation of patients' spines and sacroiliac joints through magnetic resonance imaging (MRI). The Canadian Spondyloarthritis Research Consortium (SPARCC) score serves as a magnetic resonance indicator, visually displaying the edema of the spine and sacroiliac joints, thereby objectively reflecting disease activity. The treatment results at week 16 showed that the change from baseline in the spinal score for the QX002N group was -8.1, and the change from baseline in the sacroiliac joint score was -6.2, both significantly better than the -1.4 and -2.3 in the placebo group, indicating that QX002N can effectively alleviate edema and inflammation in the spine and sacroiliac joints of the subjects, providing objective imaging evidence for the drug's ability to suppress disease activity. In terms of safety, at week 16, the incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in the QX002N group during treatment was similar to that of the placebo group, and most TEAEs were mild to moderate, indicating overall good safety. The excellent clinical symptom relief efficacy and clear imaging evidence make QX002N a promising new treatment option for AS patients. The company will also accelerate the registration application process for this product, striving for its early approval for market launch