Lynk Pharmaceuticals Announces NDA Acceptance for Zemprocitinib by NMPA

The acceptance marks a critical milestone in the company's clinical development in inflammatory skin diseases.

Apr. 10, 2026 at 12:54pm

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A highly detailed, translucent X-ray photograph of a human skin cell structure, revealing the intricate internal components and molecular pathways in a ghostly, glowing manner against a dark background, conceptually representing the complex biology of inflammatory skin diseases.A revealing X-ray view of the microscopic structures and pathways within skin cells, hinting at the potential of new targeted therapies to address the underlying biology of inflammatory skin conditions.Boston Today

Lynk Pharmaceuticals, a clinical-stage biotechnology company, announced that the New Drug Application (NDA) for its core product, zemprocitinib capsules, for the treatment of moderate-to-severe atopic dermatitis, has been formally accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA). This acceptance represents an important step toward Lynk Pharmaceuticals' transition to commercialization.

Why it matters

Atopic dermatitis is a chronic, relapsing, inflammatory skin disease that significantly impacts 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. Zemprocitinib capsules have the potential to provide a new treatment option for these patients.

The details

The NDA submission is primarily supported by positive results from a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial conducted in China. The study demonstrated that both dose groups of zemprocitinib achieved highly statistically significant improvements compared with placebo across primary and key secondary endpoints, while also exhibiting a favorable safety and tolerability profile.

  • The NDA for zemprocitinib capsules was formally accepted by the NMPA on April 10, 2026.

The players

Lynk Pharmaceuticals Co., Ltd.

A clinical-stage biotechnology company focused on the discovery and development of innovative therapies for immune and inflammatory diseases.

Zemprocitinib

Lynk Pharmaceuticals' core product, a second-generation selective JAK1 inhibitor with best-in-class potential for the treatment of moderate-to-severe atopic dermatitis.

China National Medical Products Administration (NMPA)

The regulatory authority responsible for the acceptance of Lynk Pharmaceuticals' New Drug Application for zemprocitinib.

Dr. Zhao-Kui (ZK) Wan

The Founder and Chief Executive Officer of Lynk Pharmaceuticals.

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What they’re saying

“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.”

— Dr. Zhao-Kui (ZK) Wan, Founder and Chief Executive Officer of Lynk Pharmaceuticals

What’s next

Lynk Pharmaceuticals plans to continue the development of zemprocitinib, with ongoing Phase III clinical trials in rheumatoid arthritis and ankylosing spondylitis, as well as a Phase II trial in vitiligo.

The takeaway

The acceptance of Lynk Pharmaceuticals' NDA for zemprocitinib by the NMPA represents a significant milestone in the company's efforts to address the unmet medical needs of patients with atopic dermatitis and other inflammatory conditions. This development highlights the potential of zemprocitinib to become a new treatment option for these patients.