A pivotal Phase III study has met its primary endpoint, with the Aisuda (ivarmacitinib sulfate) group achieving a 39.7% ASAS40 response rate at 12 weeks, compared to 24.8% in the placebo group (P=0.0057). This marks the fifth approved indication for ivarmacitinib sulfate, following approvals for ankylosing spondylitis, rheumatoid arthritis, atopic dermatitis, and severe alopecia areata. The drug now provides comprehensive oral targeted management across the entire spectrum of axial spondyloarthritis.
Hengrui Pharma has received approval from the National Medical Products Administration for its Class 1 innovative drug, Aisuda (ivarmacitinib sulfate), China's first self-developed highly selective JAK1 inhibitor, to treat a new indication. This applies to adult patients with active non-radiographic axial spondyloarthritis who have an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs) and show objective signs of inflammation (elevated C-reactive protein [CRP] and/or abnormal magnetic resonance imaging [MRI]). With this addition, ivarmacitinib sulfate now has five approved indications. Expanding from ankylosing spondylitis to active non-radiographic axial spondyloarthritis means the drug covers the full disease spectrum of axial spondyloarthritis with oral targeted therapy, offering new treatment options for more patients.
This new indication approval is based on a multicenter, randomized, double-blind, placebo-controlled Phase III study (SHR0302-305). Conducted across 47 research centers nationwide, the study included 304 adult patients with active non-radiographic axial spondyloarthritis who had an inadequate response or intolerance to NSAIDs. Data were presented orally at the 2026 European Alliance of Associations for Rheumatology (EULAR) congress. The primary endpoint was met significantly: at 12 weeks, 39.7% of patients in the ivarmacitinib sulfate group achieved an ASAS40 response (Assessment of SpondyloArthritis International Society improvement of ≥40%), significantly higher than 24.8% in the placebo group (P=0.0057). By week 24 of continuous treatment, the ASAS40 response rate in the ivarmacitinib sulfate group reached 57.7%. Safety was generally good throughout the 24-week trial period, with a safety profile consistent with previous studies of ivarmacitinib sulfate in ankylosing spondylitis. No cases of tuberculosis, major adverse cardiovascular events, venous thromboembolism, or new malignancies were reported, and no new safety signals were identified.
Axial spondyloarthritis is a chronic inflammatory disease primarily affecting the axial skeleton, with enthesitis as a key pathological feature. It is classified into ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis based on whether X-rays show clear sacroiliitis. About 10% of patients with non-radiographic axial spondyloarthritis progress to ankylosing spondylitis within two years. Treatment goals for non-radiographic axial spondyloarthritis focus on controlling symptoms and inflammation, preventing or delaying structural damage, and maximizing quality of life. The 2024 guidelines recommend NSAIDs as first-line drug therapy for active non-radiographic axial spondyloarthritis. However, studies show that while symptoms may improve with adequate NSAID treatment, objective inflammatory markers may not improve significantly, and some patients struggle to maintain long-term use. For patients with inadequate response or intolerance to NSAIDs and objective evidence of inflammation, guidelines recommend JAK inhibitors as a targeted treatment option. Ivarmacitinib sulfate, China's first self-developed highly selective JAK1 inhibitor, works by inhibiting JAK1 signaling to exert anti-inflammatory and immunosuppressive biological effects. This new approval provides a new oral targeted therapy option for adult patients with active non-radiographic axial spondyloarthritis who have inadequate response or intolerance to NSAIDs, with oral administration and once-daily dosing offering new possibilities for personalized treatment.
Regarding the SHR0302-305 study, this was a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial involving 47 centers nationwide. It enrolled adult patients with active non-radiographic axial spondyloarthritis meeting the 2009 ASAS classification criteria who had inadequate response or intolerance to NSAIDs. Patients were randomized 1:1 to receive either ivarmacitinib sulfate or placebo. The primary endpoint was the proportion of subjects achieving ASAS40 at 12 weeks. After unblinding at 12 weeks, the placebo group switched to ivarmacitinib sulfate, while the ivarmacitinib sulfate group continued the original regimen, with observation extended to 24 weeks.
Ivarmacitinib sulfate, launched in March 2025, now covers five indications: adult patients with active ankylosing spondylitis, moderate-to-severe active rheumatoid arthritis, moderate-to-severe atopic dermatitis, severe alopecia areata, and active non-radiographic axial spondyloarthritis with inadequate response or intolerance to NSAIDs and objective evidence of inflammation. Additional clinical studies are ongoing for conditions including psoriatic arthritis, ulcerative colitis, and vitiligo.
Hengrui Pharma, an innovative international pharmaceutical company focused on R&D, production, and marketing of high-quality drugs, has maintained R&D spending above 25% of revenue for consecutive years, building a diversified and robust pipeline. To date, the company has 26 Class 1 and 6 Class 2 innovative drugs approved in China, with over 100 self-developed products in clinical development and more than 400 clinical trials underway globally. Internationally, its products are commercialized in over 50 countries, with 13 overseas licensing deals completed in the past three years and continued efforts to build global clinical and commercial capabilities.
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