SIMCERE PHARMA (02096.HK): zemprocitinib RA NDA accepted by NMPA

NewTimeSpace News: On 6 November 2026, Simcere Pharmaceutical Group Limited (02096.HK) announced voluntarily that the new drug application for zemprocitinib, a highly selective second-generation JAK1 inhibitor developed in cooperation with Lynk Pharmaceuticals, for the treatment of moderate-to-severe active rheumatoid arthritis has been formally accepted by the National Medical Products Administration. This is the second indication of zemprocitinib to enter the regulatory review stage in China, following adult moderate-to-severe atopic dermatitis.

The application was mainly based on the positive results of a multi-center, randomised, double-blind, placebo-controlled Phase III clinical study in China. Led by Professor Zeng Xiaofeng of Peking Union Medical College Hospital, the study enrolled 430 patients with moderate-to-severe active rheumatoid arthritis who had an inadequate response or intolerance to prior biologic therapies. The results showed that zemprocitinib demonstrated statistically significant (p<0.0001) efficacy advantages over placebo on the primary endpoint and key secondary endpoints, with a generally favourable safety and tolerability profile.

Long-term follow-up showed that among patients continuously treated through week 76, the ACR20 and ACR50 response rates were maintained at 91.8% and 80.5% respectively, while the ACR70 response rate further improved from 52.5% at week 52 to 62.4% at week 76. Zemprocitinib was independently developed by Lynk Pharmaceuticals, with which the group entered into a cooperation in March 2022 to obtain exclusive commercialization rights in mainland China, Hong Kong, Macau and Taiwan for rheumatoid arthritis and ankylosing spondylitis.