NMPA Accepts Lynk's Zemprocitinib NDA for Rheumatoid Arthritis
Shanghai – November 06, 2026 -- China's Center for Drug Evaluation (CDE) accepted Lynk Pharmaceuticals' New Drug Application for zemprocitinib in moderate-to-severe active rheumatoid arthritis (RA) on November 4, moving the oral JAK1 inhibitor into regulatory review.
430-patient Phase III trial beat placebo at p<0.0001
The filing rests on a randomized, double-blind, placebo-controlled, multicenter Phase III trial in China. It enrolled 430 adults with moderate-to-severe active RA who had an inadequate response or intolerance to prior biologic disease-modifying antirheumatic drugs (bDMARDs). Zemprocitinib showed statistically significant efficacy over placebo on the primary and key secondary endpoints (p<0.0001). Lynk reports an overall favorable safety and tolerability profile.