Lynk Pharmaceuticals Co., Ltd. ("Lynk Pharmaceuticals"), a clinical-stage innovative drug development company focused on therapies for immune and inflammatory diseases, 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 III 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.

Dr. Zhao-Kui (ZK) Wan, Founder and Chief Executive Officer of Lynk Pharmaceuticals said: "The submission and acceptance of the NDA for zemprocitinib represent a significant achievement in our continued focus on autoimmune and inflammatory diseases. We remain committed to developing innovative medicines with strong clinical value and global competitiveness, and we look forward to bringing this therapy to patients with atopic dermatitis as soon as possible."