[ 메디채널 김갑성 기자 ] SHANGHAI, HANGZHOU, China and BOSTON, March 2, 2026 -- Lynk Pharmaceuticals Co., Ltd. ("Lynk Pharmaceuticals"), a clinical-stage innovative drug development company focused on therapies for immune and inflammatory diseases, today announced positive topline results from its Phase III clinical trial evaluating zemprocitinib in patients with moderate-to-severe atopic dermatitis (AD). The study met all co-primary and key secondary endpoints, with both dose groups demonstrating highly and statistically significant improvements versus placebo (p < 0.0001), together with a favorable safety and tolerability profile.

The disclosed results represent topline data generated in accordance with the predefined statistical analysis plan. Full study data are undergoing further analysis and will be published at a future date.

This study was a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of zemprocitinib in patients with moderate-to-severe atopic dermatitis. The trial was led by Professor Jianzhong Zhang and Professor Cheng Zhou of Peking University People's Hospital. A total of 356 patients were randomized in a 1:1:1 ratio to receive zemprocitinib 12 mg, or 24 mg or placebo.

The study had two co-primary endpoints at Week 16; the proportion of patients achieving ≥75% improvement from baseline in Eczema Area and Severity Index (EASI-75); and the proportion of patients achieving a validated Investigator Global Assessment for Atopic Dermatitis score of 0 (clear) or 1 (almost clear), with a ≥2-point improvement from baseline (vIGA-AD 0/1 response). The key secondary endpoint was the proportion of patients achieving a ≥4-point improvement from baseline in Worst Itch Numerical Rating Scale (WI-NRS4) at Week 16.

At Week 16, both zemprocitinib dose groups demonstrated statistically significant superiority over placebo across both co-primary endpoints and the key secondary endpoint:

• EASI-75: Differences versus placebo were 38.1% (12 mg) and 46.4% (24 mg) (p < 0.0001).
• vIGA-AD 0/1 response: Improvements over placebo were 30.3% (12 mg) and 31.0% (24 mg) (p < 0.0001).
• WI-NRS4 response rates were 31.3% (12 mg) and 31.0% (24 mg) higher than placebo at Week 16 (p < 0.0001).

Zemprocitinib also achieved statistically significant improvements across multiple additional secondary endpoints, including EASI-50, EASI-90, SCORAD response rates, Dermatology Life Quality Index (DLQI), and Patient-Oriented Eczema Measure (POEM) scores, supporting broad clinical benefit in lesion clearance, symptom reduction, and quality-of-life improvement. Notably, zemprocitinib demonstrated a rapid onset of action. Improvement in pruritus was observed as early as Day 1 following initiation of therapy, with statistically significant separation from placebo in WI-NRS response rates, indicating rapid itch relief. Statistically significant improvement in EASI-75 response rates and vIGA-AD 0/1 response rates were also observed by Week 2 in both dose groups, highlighting the treatment's early efficacy in skin lesion improvement.

Zemprocitinib demonstrated a favorable overall safety and tolerability profile. The majority of treatment-emergent adverse events (TEAEs) were Grade 1–2. The incidence of serious adverse events (SAEs), adverse events of special interest (AESIs), and discontinuations due to adverse events were low and comparable to placebo, with no new safety signals observed. Laboratory findings were consistent with those observed in the Phase III rheumatoid arthritis study. No serious adverse reactions related to decreases in hemoglobin, neutrophils, or lymphocytes were observed and there were no safety concerns associated with elevations in ALT or AST. No dose-dependent differences in the safety profile were observed. Overall, the safety profile was consistent with our prior clinical studies and demonstrated competitive characteristics relative to other reported JAK inhibitors.

Professor Jianzhong Zhang, principal investigator from Peking University People's Hospital, stated: "Atopic dermatitis is a chronic, relapsing inflammatory and pruritic skin disease that imposes a substantial burden on patients' quality of life and mental health. In this Phase III study, zemprocitinib demonstrated significant improvements in both skin lesion clearance and itch relief, together with a favorable overall safety profile. We look forward to the potential of zemprocitinib to provide a new oral treatment option for patients with moderate-to-severe atopic dermatitis in China."

Dr. Yu Wu, Chief Development Officer of Lynk Pharmaceuticals, commented: "The success of this Phase III study reflects the strength of our long-term strategic focus in immunology and inflammation. These results further validate the potential of zemprocitinib across multiple autoimmune indications and reinforce our clinical development capabilities. We remain committed to advancing regulatory submissions with scientific rigor and high-quality standards."

Dr. Zhao-Kui (ZK) Wan, Founder and Chief Executive Officer of Lynk Pharmaceuticals, added: "We are highly encouraged by these positive Phase III results in atopic dermatitis and sincerely thank the patients, investigators, and our internal and external teams for their dedication and professionalism. Following the successful Phase III study in rheumatoid arthritis, this achievement represents another important milestone for zemprocitinib and further reinforces its positioning as a core asset in our pipeline. The favorable balance of efficacy and safety supports its potential differentiated profile in the competitive JAK landscape."

About Zemprocitinib

Zemprocitinib is a highly selective, next-generation JAK1 inhibitor with best-in-class potential, being developed for the treatment of rheumatoid arthritis, ankylosing spondylitis, atopic dermatitis, and vitiligo. Compared with first-generation, less selective JAK inhibitors, zemprocitinib demonstrates significantly greater selectivity for JAK1, which may translate into desirable efficacy while minimizing off-target adverse effects. Zemprocitinib potently and dose-dependently inhibits multiple inflammation-related signaling pathways mediated by JAK1.

About Lynk Pharmaceuticals

Lynk Pharmaceuticals is a clinical-stage biotechnology company founded by senior drug R&D leaders and executives from Pfizer, Merck, and Johnson & Johnson. The company is dedicated to the discovery and development of innovative therapies for immune and inflammatory diseases. Driven by a commitment to address significant unmet medical needs, Lynk Pharmaceuticals aims to deliver differentiated therapies with global impact. To date, the company has independently or jointly advanced multiple innovative drug candidates and successfully completed numerous clinical studies.