Lynk Pharmaceuticals, a clinical-stage innovative drug development company focused on therapies for immune and inflammatory diseases, has announced that the New Drug Application (NDA) for its core product, zemprocitinib capsules, for the treatment of moderate-to-severe atopic dermatitis (AD), has been formally accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA).
This acceptance marks a critical milestone in the company’s clinical development in inflammatory skin diseases and represents an important step toward Lynk Pharmaceuticals’ transition to commercialization. Zemprocitinib capsules have the potential to provide a new treatment option for patients with atopic dermatitis.
Atopic dermatitis is a chronic, relapsing, inflammatory skin disease characterized by pruritus and impaired skin barrier function, significantly impacting patients’ quality of life. Despite the availability of various treatment options, a substantial proportion of patients have inadequate responses or face long-term safety challenges, leaving significant unmet medical needs.
The NDA submission is primarily supported by positive results from a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial (NCT06277245) conducted in China. The study demonstrated that both dose groups of zemprocitinib achieved highly statistically significant improvements (p < 0.0001) compared with placebo across primary and key secondary endpoints, while also exhibiting a favorable safety and tolerability profile.
About Zemprocitinib
Zemprocitinib is a second-generation selective JAK1 inhibitor with best-in-class potential. In addition to the completed 52-week phase 3 clinical trial in atopic dermatitis, the phase 3 clinical trial in rheumatoid arthritis (RA) has progressed into the treatment extension phase. A phase 3 trial in ankylosing spondylitis (AS) is currently ongoing, and a phase 2 trial in vitiligo is in the startup phase.
Preclinical and clinical studies have demonstrated that zemprocitinib potently and dose-dependently inhibits multiple JAK1-mediated inflammatory signaling pathways, supporting its therapeutic potential across a range of indications, including AD, RA, and AS.
Compared with first-generation JAK inhibitors that have lower selectivity, zemprocitinib exhibits greater selectivity for JAK1, which may reduce the risk of off-target adverse effects. Across all completed or unblinded clinical studies, including phase 2 trials in AD, RA, and AS; the week 24 data readout from the phase 3 RA study; and the completed phase 3 trial in AD, zemprocitinib has demonstrated a favorable safety and tolerability profile.
The incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) was comparable to placebo, and laboratory safety parameters were generally well maintained. Overall, its safety profile is consistent in all completed or unblinded studies and compares favorably with those of reported JAK inhibitors.
