Crusekitug（QX002N）, as one of our Core Products, is a high-affinity mAb targeting IL-17A, a key player in the pathological mechanism of various autoimmune diseases. IL-17A inhibitors, together with TNF-α inhibitors, are recommended by prevailing clinical guidelines as second-line treatment for ankylosing spondylitis (AS) patients with high disease activity after receiving first-line traditional treatments. Between the two classes of biologics, IL-17A inhibitors have shown clear clinical benefit in patients who are TNF- α naive, as well as in those who are intolerant to or have an inadequate response to TNF- α inhibitors.

Phase III clinical trial results were presented as an oral presentation at the 2025 annual meeting of the American College of Rheumatology (ACR Convergence) held in Chicago, the United States. The results showed that at week 16, the ASAS40 response rate in the Crusekitug 160mg every 4 weeks (Q4W) group was 40.4%, significantly higher than the 18.9% in the placebo group (P < 0.0001). The ASAS20 response rate at the same time point in the Crusekitug group was 65.2%, also significantly higher than 41.3%in the placebo group (P < 0.0001). By Week 52, the ASAS20 and ASAS40 response rates in the Crusekitug group were 87.2% and 70.2%, respectively. The clinical trial successfully met both its primary and key secondary endpoints. Significant efficacy was also demonstrated in the TNF- α inhibitor-experienced population. Furthermore, Crusekitug effectively alleviated edema and inflammation in the spine and sacroiliac joints of the subjects, providing clear objective imaging evidence for its role in suppressing disease activity.

As of April 2026, the New Drug Application (NDA) for Crusekitug for the treatment of active ankylosing spondylitis (AS) in adults was accepted by the National Medical Products Administration (NMPA) on March 9, 2026.