Lynk Expands Simcere Deal for Zemprocitinib in Atopic Dermatitis

Lynk Pharmaceuticals has expanded its commercialization agreement with Simcere Pharmaceutical Group to include zemprocitinib for moderate-to-severe atopic dermatitis (AD) in adults and other dermatology indications across Greater China. The expansion follows completion of the drug’s pivotal Phase III AD study and acceptance of its New Drug Application (NDA) for regulatory review in China.

Expanded Commercialization Rights Cover Dermatology

Under the expanded agreement, Simcere will secure exclusive commercialization rights for zemprocitinib in Chinese Mainland, Hong Kong, Macau and Taiwan for moderate-to-severe atopic dermatitis in adults and other dermatology indications.

The agreement builds on the companies’ March 2022 collaboration, under which Simcere obtained exclusive commercialization rights for zemprocitinib in rheumatoid arthritis (RA) and ankylosing spondylitis (AS) across the same territories.

By extending the partnership into dermatology, the companies are broadening the drug’s commercial scope beyond rheumatology and immunology. The arrangement also allows Lynk to leverage Simcere’s existing dermatology commercial infrastructure while retaining its focus on drug discovery and clinical development.

Zemprocitinib Advances Toward Atopic Dermatitis Commercialization

Zemprocitinib is an oral, highly selective, second-generation Janus kinase 1 (JAK1) inhibitor discovered and developed by Lynk Pharmaceuticals.

JAK1 plays an important role in intracellular signalling pathways involved in inflammatory and immune responses. Selective JAK1 inhibition can suppress multiple cytokine-mediated inflammatory pathways implicated in autoimmune and inflammatory diseases, including atopic dermatitis.

The drug’s development programme covers three major indications: atopic dermatitis, rheumatoid arthritis and ankylosing spondylitis.

In adults with moderate-to-severe atopic dermatitis, zemprocitinib has completed its pivotal Phase III clinical study. China’s Center for Drug Evaluation (CDE), under the National Medical Products Administration (NMPA), accepted its NDA for review in April 2026.

This regulatory milestone moves the AD programme closer to a potential commercial launch in China. However, NDA acceptance does not constitute marketing approval, and the company has not disclosed an approval decision or launch timeline in the collaboration announcement.

Rheumatoid Arthritis and Ankylosing Spondylitis Programmes Continue

Beyond dermatology, zemprocitinib has also advanced through late-stage development in rheumatology.

Lynk has completed the Phase III clinical study in rheumatoid arthritis, while its Phase III clinical programme for ankylosing spondylitis remains ongoing.

The expansion of the Simcere agreement therefore creates a broader commercialization framework covering multiple inflammatory and autoimmune indications. It also positions the drug for potential use across dermatology and rheumatology, subject to successful regulatory outcomes in each indication.

Commercial Strategy Builds on Existing Partnership

Simcere President Yunshu Zhou highlighted zemprocitinib’s clinical progress across atopic dermatitis and rheumatoid arthritis, noting that the expanded collaboration would complement the company’s existing dermatology portfolio.

Lynk Founder, Chairman and CEO Zhao-Kui Wan described the agreement as an important step as zemprocitinib approaches the commercialization stage in atopic dermatitis. He pointed to Simcere’s immunology commercial experience as a complement to Lynk’s research and development capabilities.

The expanded partnership reflects Lynk’s strategy of combining internal drug development with established commercial partners to support market entry across multiple therapeutic areas.

Regulatory Review Remains the Key Near-Term Milestone

The immediate development priority for zemprocitinib is the outcome of China’s regulatory review for moderate-to-severe atopic dermatitis. A positive decision would establish its first potential commercial entry point under the expanded dermatology collaboration.

The completed Phase III rheumatoid arthritis programme and ongoing Phase III ankylosing spondylitis programme provide additional opportunities to broaden its clinical and commercial reach.

For Lynk, the expanded agreement strengthens the commercialization pathway for its JAK1 inhibitor without requiring it to independently establish a dermatology sales infrastructure. For Simcere, it adds a late-stage investigational therapy to its dermatology portfolio, with the potential to expand its presence in inflammatory skin diseases.

Reference

Lynk Pharmaceuticals Announces Commercialization Collaboration with Simcere for Zemprocitinib in Dermatology Indications, Further Expanding Product Commercialization Footprint, Lynk Pharmaceutical, 02 November 2026