By Fineline Cube 
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that Its wholly-owned subsidiary Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd has received approval from the National Medical Products Administration (NMPA) to initiate a Phase III clinical study for its 0.3% roflumilast foam (trade name: Zorvye). The study will evaluate the drug as a topical treatment for seborrheic dermatitis in patients aged 9 years and older.
Drug Mechanism
Roflumilast, a phosphodiesterase-4 (PDE4) inhibitor, works by reducing pro-inflammatory mediators and increasing anti-inflammatory mediators, thereby alleviating inflammation. This mechanism of action makes it effective in treating inflammatory skin conditions.
Licensing and Previous Approvals
Licensed from US-based Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), roflumilast foam was previously approved in the US and Canada for seborrheic dermatitis. It also received FDA approval in May 2025 for the treatment of scalp and body psoriasis in patients aged 12 and older.
Clinical Trial Results
Clinical studies have demonstrated the strong safety and tolerability of roflumilast foam in patients with seborrheic dermatitis. Notably, 80% of patients achieved complete or near-complete clearance by Week 8 of the trials.-Fineline Info & Tech