LEO Pharma A/S announced that Anzupgo (delgocitinib cream) has been approved by China’s National Medical Products Administration (NMPA) for the topical treatment of moderate‑to‑severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate. Anzupgo is the world’s first and currently only topical pan‑JAK inhibitor approved for moderate‑to‑severe CHE in adults.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | NMPA (China) |
| Approval Type | Marketing approval – new product |
| Product | Anzupgo (delgocitinib cream), topical, twice daily |
| Indication | Moderate‑to‑severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate |
| Approval Date | 13 Nov 2026 |
| Data Basis | Positive Phase 3 DELTA China clinical trial |
Drug Profile & Mechanism of Action
- Molecule: Delgocitinib, formulated as a topical cream applied twice daily.
- Target: Pan‑JAK inhibition – blocks JAK1, JAK2, JAK3, and TYK2, modulating multiple inflammatory signaling pathways implicated in CHE.
- Innovation: The world’s first and currently only topical pan‑JAK inhibitor for moderate‑to‑severe CHE in adults, offering a non‑steroidal mechanism for a disease with few advanced topical options.
- Label Positioning: Indicated specifically for patients inadequately controlled by, or unsuitable for, topical corticosteroids – addressing the second‑line treatment gap.
Clinical Evidence – Phase 3 DELTA China Trial
| Item | Detail |
|---|---|
| Design | Double‑blind, vehicle‑controlled Phase 3 trial |
| Population | Chinese adults and adolescents aged ≥12 years with moderate‑to‑severe CHE |
| Regimen | Anzupgo cream, twice daily |
| Primary Endpoint | Improvement in CHE severity after 16 weeks of treatment vs. cream vehicle |
| Result | Primary endpoint met – statistically significant improvement in CHE severity vs. vehicle; magnitude of effect not disclosed |
| Safety & PK | Efficacy, safety, and pharmacokinetics evaluated; specific safety data not disclosed |
The approval rests on the DELTA China program, which assessed efficacy, safety, and pharmacokinetics of twice‑daily Anzupgo in the Chinese population. Notably, the trial enrolled patients from age 12, while the current China label covers adults only; any future pediatric label expansion was not disclosed.
Market Impact & Outlook
- Large Unmet Need: CHE is a chronic, relapsing inflammatory skin disease of the hands associated with substantial quality‑of‑life and occupational burden; patients failing topical corticosteroids have historically had limited approved options in China.
- First‑Mover Advantage: As the first and only topical pan‑JAK inhibitor for CHE globally, Anzupgo establishes a differentiated, non‑steroidal category ahead of potential competitors.
- China Market Entry: The NMPA approval extends LEO Pharma’s dermatology franchise into the world’s second‑largest pharmaceutical market, reinforcing its specialization‑driven growth strategy in medical dermatology.
- Commercial Terms: Pricing, launch timing, and distribution arrangements were not disclosed.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the commercialization and clinical development of Anzupgo (delgocitinib cream) in China, including market adoption and potential label expansion. Actual results may differ materially due to risks including reimbursement and pricing decisions, competitive dynamics, real‑world safety experience, and regulatory developments.-Fineline Info & Tech
