Core Viewpoint - The company announced the results of its Phase III clinical trial for QX002N, a monoclonal antibody for ankylosing spondylitis, which showed significant efficacy compared to the placebo group [1] Group 1: Clinical Trial Details - The Phase III clinical study was led by Professor Zeng Xiaofeng from Peking Union Medical College Hospital and involved 641 patients across 58 centers in China [1] - The study design was multi-center, randomized, double-blind, and placebo-controlled, with a treatment period of 48 weeks and a safety follow-up of 4 weeks [1] - Patients were randomly assigned in a 1:1 ratio to receive either 160mg of QX002N or a placebo, administered subcutaneously every four weeks [1] Group 2: Efficacy Results - At week 16, the ASAS40 response rate for the QX002N group was 40.4%, significantly higher than the 18.9% in the placebo group (P<0.0001) [1] - The ASAS20 response rate for the QX002N group was 65.2%, also significantly higher than the placebo group (P<0.0001) [1] - These results indicate that QX002N effectively alleviates symptoms and signs of ankylosing spondylitis across multiple dimensions, including pain and spinal function [1]
荃信生物-B(02509.HK)鲁塞奇塔单抗(QX002N)强直性脊柱炎III期临床研究成果亮相2025年ACR年会