荃信生物鲁塞奇塔单抗上市申请获受理，用于治疗强直性脊柱炎

Core Viewpoint - The article highlights the progress of Qianxin Biopharmaceutical's integrated platform, marking a significant milestone with the acceptance of its first innovative drug application for QX002N, aimed at treating adult active ankylosing spondylitis (AS) [2]. Group 1: Drug Development and Approval - Qianxin Biopharmaceutical announced that its innovative drug QX002N's new drug application (NDA) has been accepted by the National Medical Products Administration, indicating the company's effective output capability in complex antibody drug development [2]. - QX002N is a high-affinity monoclonal antibody targeting IL-17A, which plays a crucial role in various autoimmune diseases, including AS, by exacerbating inflammation and regulating bone metabolism [2]. - The NDA acceptance is based on a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial, with core results presented at the ACR Convergence in October 2025, demonstrating the drug's efficacy and safety [3]. Group 2: Clinical Trial Results - The clinical trial results indicate that QX002N significantly improves disease activity and clinical symptoms in active AS patients who have inadequate response to non-steroidal anti-inflammatory drugs or have contraindications [4]. - The drug also shows clear therapeutic benefits for patients previously treated with tumor necrosis factor (TNF) inhibitors, providing objective imaging evidence of reduced edema and inflammation in the spine and sacroiliac joints [4].