SIMCERE PHARMA (02096): NDA for Zeputinib in the Treatment of Rheumatoid Arthritis Accepted by the National Medical Products Administration

SIMCERE PHARMA (02096) announced that the New Drug Application (NDA) for zeputinib, a highly selective second-generation JAK1 inhibitor developed in collaboration with Lynk Pharmaceuticals, for the treatment of moderate-to-severe active rheumatoid arthritis, has been officially accepted by China's National Medical Products Administration. This is the second indication for zeputinib in China to enter the regulatory review stage, following the indication for moderate-to-severe atopic dermatitis in adults. This application is primarily based on the positive results of a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study conducted in China. The study was led by Professor Zeng Xiaofeng of Peking Union Medical College Hospital and enrolled a total of 430 patients with moderate-to-severe active rheumatoid arthritis who had inadequate response or intolerance to prior biologic therapies. The results showed that zeputinib demonstrated statistically significant efficacy advantages over the placebo group in the primary endpoint and key secondary endpoints (p<0.0001), with an overall favorable safety and tolerability profile. Long-term follow-up data further confirmed the sustained benefits of zeputinib. Among patients who continued treatment through Week 76, the American College of Rheumatology 20% improvement criteria (ACR20) and 50% improvement criteria (ACR50) response rates remained at 91.8% and 80.5%, respectively; the ACR70 response rate further increased from 52.5% at Week 52 to 62.4% at Week 76. In addition, zeputinib demonstrated sustained and stable efficacy in indicators such as disease activity score (DAS28-CRP3.2) and improvement in physical function (HAQ-DI improvement 0.22).