By Fineline Cube 
Huadong Medicine Co., Ltd. (SHE: 000963) announced that China’s National Medical Products Administration (NMPA) has accepted the company’s New Drug Application (NDA) for Roflumilast Cream 0.15 % (brand name ZORYVE). The product is intended for the topical treatment of mild‑to‑moderate atopic dermatitis in patients 6 years of age and older.
Deal & Licensing Structure
| Item | Detail |
|---|---|
| Applicant | Huadong Medicine Co., Ltd. (000963.SZ) |
| Product | Roflumilast Cream 0.15 % – brand name ZORYVE |
| Indication | Topical therapy for mild‑to‑moderate atopic dermatitis (≥ 6 yr) |
| Regulatory Milestone | NMPA acceptance of NDA (12 Nov 2025) |
| Licensor | Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT) |
| Licensee | Sino‑American Huadong (wholly‑owned Huadong subsidiary) |
| Geographic Rights | Exclusive development, registration, manufacturing & commercialization in Greater China (Mainland, Hong Kong, Macau, Taiwan) and Southeast Asia (Indonesia, Singapore, Philippines, Thailand, Myanmar, Brunei, Cambodia, Laos, Malaysia, Vietnam) |
| Launch Timeline | Expected market authorization Q2 2026; commercial launch in Greater China Q3 2026, followed by staggered rollout across Southeast Asia through 2027 |
Scientific Rationale
- Active Ingredient: Roflumilast, a highly potent, selective non‑steroidal phosphodiesterase‑4 (PDE‑4) inhibitor.
- Mechanism of Action: PDE‑4 catalyzes the breakdown of cyclic AMP, driving the production of pro‑inflammatory cytokines while suppressing anti‑inflammatory mediators. Inhibition restores the cAMP balance, reducing skin inflammation and pruritus associated with atopic dermatitis.
- Differentiation: Unlike topical steroids, ZORYVE offers a steroid‑free anti‑inflammatory option, potentially lowering the risk of skin atrophy and tachyphylaxis with long‑term use.
Market Opportunity
- Epidemiology: Atopic dermatitis affects ≈ 15 % of Chinese children and ≈ 5 % of adults, representing a $3.2 billion addressable market in Greater China alone.
- Unmet Need: Current therapy relies heavily on topical corticosteroids and calcineurin inhibitors, both with safety or tolerability concerns for chronic use.
- Revenue Forecast (Huadong): Assuming a 4 % market share within three years of launch, projected annual sales of CNY 1.1–1.4 billion (≈ US$150–190 million) in Greater China. Expansion into Southeast Asia could add an additional US$80–110 million by 2029.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory timelines, commercial launch expectations, and revenue projections for ZORYVE. Actual results may differ due to risks including clinical outcomes, regulatory approvals, market acceptance, competitive dynamics, and manufacturing scale‑up.-Fineline Info & Tech