By Fineline Cube 
Lynk Pharmaceuticals Co., Ltd. announced positive Phase II data for its self‑developed Class 1 innovative drug LNK01004, a skin‑restricted pan‑JAK inhibitor ointment, demonstrating statistically significant EASI‑75 response rates in adult atopic dermatitis (AD) patients, with prominent efficacy in moderate‑to‑severe cases and minimal systemic exposure.
Trial Milestone
| Item | Detail |
|---|---|
| Product | LNK01004 ointment (skin‑restricted pan‑JAK inhibitor) |
| Company | Lynk Pharmaceuticals Co., Ltd. |
| Phase | Phase II (randomized, double‑blind, vehicle‑controlled, parallel‑group) |
| Patients | 75 adult AD subjects randomized 1:1:1 |
| Dosing | 0.3% ointment, 1.0% ointment, or vehicle, applied BID for 8 weeks |
| Primary Endpoint | EASI‑75 response rate at Week 8 |
| Key Result | Both dose groups achieved higher EASI‑75 vs vehicle, advantage amplified in BSA≥10% subgroup |
| Next Step | Phase III initiation planned for H2 2026 |
Drug Profile
- Class: First‑in‑class skin‑restricted pan‑JAK inhibitor designed for topical administration
- Mechanism: Selectively inhibits JAK signaling within skin tissue, minimizing systemic circulation
- Innovation: Lipophilic formulation achieves high local concentration while maintaining low systemic exposure—several hundred‑fold below whole‑blood IC50
- Pipeline: LNK01004 is Lynk’s lead dermatology asset; focused on AD with potential expansion to other inflammatory skin diseases
Clinical Evidence Summary
| Endpoint | 0.3% LNK01004 | 1.0% LNK01004 | Vehicle |
|---|---|---|---|
| EASI‑75 (BSA≥10%) | 61.1% | 46.2% | 20% |
| vIGA‑AD 0/1 (BSA≥10%) | 44.4% | 38.5% | 10% |
| EASI‑75 (BSA≥20%) | Prominent advantage vs vehicle, underscoring potential in moderate‑to‑severe AD |
All p‑values <0.05 for active arms vs vehicle in BSA≥10% cohort.
Safety Profile
- Systemic Exposure: Mean Cmax 0.0628 ng/mL (0.3%) and 0.1499 ng/mL (1.0%), >100‑fold below human whole‑blood IC50
- Tolerability: All treatment‑related adverse events (TRAEs) were mild or moderate (Grade 1/2)
- Serious AEs: No drug‑related serious adverse events (SAEs) observed
- Consistency: Safety profile aligns with earlier‑stage studies, supporting favorable risk‑benefit
Market Impact & Outlook
- China AD Market: ~25 million AD patients; moderate‑to‑severe segment represents 30‑40% of cases with limited topical options beyond corticosteroids and calcineurin inhibitors
- Competitive Edge: Oral JAK inhibitors (e.g., upadacitinib) carry systemic safety warnings; LNK01004’s skin‑restricted profile offers a topical alternative with JAK‑class efficacy and minimal systemic risk
- Revenue Forecast: Analysts project China peak sales potential of ¥800 million‑1.2 billion (~US$110‑165 million) by 2032, assuming 15‑20% share of moderate‑to‑severe AD topical market
- Regulatory Path: Phase II success positions LNK01004 for Breakthrough Therapy Designation with NMPA, accelerating review timeline
- Next Catalysts: Phase III protocol agreement expected Q1 2026; data readout targeted for 2027, contingent on enrollment speed
Forward‑Looking Statements
This brief contains forward‑looking statements regarding LNK01004’s clinical development, regulatory pathway, and commercial prospects. Actual results may differ materially due to risks including Phase III execution, competitive dynamics, and market adoption of topical JAK inhibitors.-Fineline Info & Tech