QYUNS-B (02509): Lusecitabine monoclonal antibody (QX002N) Ankylosing Spondylitis Phase III clinical research results debuted at the 2025 ACR Annual Meeting.

QYUNS-B (02509) announced that on October 27, 2025, the results of the Phase III clinical study of Luseketan monoclonal antibody (QX002N) developed independently by the company for the treatment of ankylosing spondylitis (AS) were presented in oral form at the 2025 American College of Rheumatology Annual Meeting (ACR Convergence) held in Chicago, USA. The study was led by Professor Zeng Xiaofeng from the Rheumatology and Immunology Department of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences. It was a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study. The study included a 48-week treatment period (16-week double-blind treatment period and 32-week open-label treatment period) and a 4-week safety follow-up period, covering 58 research centers in China. 641 patients were randomly assigned in a 1:1 ratio to receive 160mg of Luseketan monoclonal antibody or placebo (subcutaneous administration, once every four weeks, Q4W). The primary endpoint of the study was the proportion of subjects achieving an ASAS40 response at week 16. The results showed that at week 16, the ASAS40 response rate in the Luseketan monoclonal antibody group was as high as 40.4%, significantly higher than the 18.9% in the placebo group (P<0.0001). Additionally, the ASAS20 response rate in the Luseketan monoclonal antibody group was 65.2%, also significantly higher than the placebo group (P<0.0001), indicating that Luseketan monoclonal antibody could effectively relieve symptoms and signs of AS patients from pain and spinal function in multiple dimensions. In addition to the improvement in clinical symptoms and spinal function, the study also assessed the inflammation of the patients' spine and sacroiliac joints using magnetic resonance imaging (MRI). The Spondyloarthritis Research Consortium of Canada (SPARCC) score was used as an MRI indicator to visually demonstrate the edema of the spine and sacroiliac joints, reflecting disease activity objectively. The results at week 16 showed that the change in spine score from baseline in the Luseketan monoclonal antibody group was -8.1, and the change in sacroiliac joint score from baseline was -6.2, both significantly better than the -1.4 and -2.3 in the placebo group, indicating that Luseketan monoclonal antibody could effectively relieve edema and inflammation in the spine and sacroiliac joints of subjects, providing objective imaging evidence for the inhibition of disease activity by the drug. In terms of safety, at week 16, the incidence of treatment-emergent adverse events (TEAE) and serious adverse events (SAE) in the Luseketan monoclonal antibody group during the treatment period was similar to that of the placebo group, and most TEAE were mild to moderate, indicating overall good safety. With excellent clinical symptom relief efficacy and clear imaging evidence, Luseketan monoclonal antibody is expected to become a new treatment option for AS patients. The company will also expedite the registration application process for this product to seek early approval for market launch.