Lynk Pharmaceuticals Announces NDA Acceptance for Zemprocitinib by NMPA

Zemprocitinib capsules have the potential to provide a new treatment option for patients with atopic dermatitis.

Apr. 10, 2026 at 12:36pm

Got story updates? Submit your updates here. ›

An extreme close-up X-ray photograph showing the intricate internal structure of a pharmaceutical capsule, with the contents glowing against a dark background, conceptually representing the innovative nature of Lynk Pharmaceuticals' new drug candidate.Lynk Pharmaceuticals' zemprocitinib capsules, revealed through advanced X-ray imaging, hold the potential to provide a new treatment option for patients with atopic dermatitis.Boston Today

Lynk Pharmaceuticals, a clinical-stage drug development company, 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.

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. The acceptance of the NDA for zemprocitinib represents a significant achievement in Lynk Pharmaceuticals' continued focus on developing innovative medicines to address autoimmune and inflammatory diseases.

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.

Dr. Zhao-Kui (ZK) Wan

Founder and Chief Executive Officer of Lynk Pharmaceuticals.

Center for Drug Evaluation (CDE)

A division of the China National Medical Products Administration (NMPA) that is responsible for the evaluation and approval of new drug applications.

China National Medical Products Administration (NMPA)

The national regulatory authority in China responsible for the supervision and management of medical products, including drugs, medical devices, and cosmetics.

Zemprocitinib

Lynk Pharmaceuticals' core product, a second-generation selective JAK1 inhibitor with potential for the treatment of atopic dermatitis, rheumatoid arthritis, and other inflammatory conditions.

Got photos? Submit your photos here. ›

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

The next step for Lynk Pharmaceuticals is to work with the NMPA to complete the review process for the zemprocitinib NDA, with the goal of obtaining regulatory approval and bringing the therapy to patients with atopic dermatitis in China as soon as possible.

The takeaway

The acceptance of the NDA for zemprocitinib by the NMPA represents a significant milestone for Lynk Pharmaceuticals in its efforts to develop innovative treatments for autoimmune and inflammatory diseases. If approved, zemprocitinib could provide a new treatment option for patients with atopic dermatitis, addressing an important unmet medical need.