Lynk Pharmaceuticals Co Ltd, a clinical-stage innovative drug company focused on autoimmune and inflammatory diseases, announced on Thursday that the New Drug Application (NDA) for its core product, zemprocitinib capsules, for the treatment of moderate-to-severe active rheumatoid arthritis (RA) has been formally accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA).

This marks the advancement of zemprocitinib into the regulatory review stage for rheumatoid arthritis, with the potential to offer a new oral treatment option for patients with an inadequate response to biologics.

The NDA submission is supported by positive results from a randomised, double-blind, placebo-controlled Phase III clinical trial conducted across multiple centres in China. The study enrolled 430 adult patients with moderate-to-severe active RA who had an inadequate response or intolerance to prior biologic disease-modifying antirheumatic drugs (bDMARDs). The study demonstrated statistically significant efficacy advantages for zemprocitinib over placebo across the primary and key secondary endpoints, with an overall favourable safety and tolerability profile.

According to Lynk, zemprocitinib is a second-generation, highly selective oral JAK1 inhibitor with best-in-class potential.