Huadong Medicine's subsidiary receives NMPA acceptance for Roflumilast cream

On November 10, 2025, Huadong Medicine's wholly-owned subsidiary received a notice of acceptance from the National Medical Products Administration (NMPA) for the marketing authorization application of Roflumilast Cream (ZORYVE®) 0.15%. The drug, classified as a chemical drug category 5.1, is indicated for the topical treatment of mild to moderate atopic dermatitis in patients aged 6 years and older. This application marks a crucial step in bringing this innovative external preparation to the Chinese market.

Roflumilast Cream is an innovative topical formulation product introduced by Huadong Medicine's subsidiary through a cooperation agreement with Arcutis Biotherapeutics, Inc. in August 2023. Huadong Medicine holds exclusive rights for development, registration, production, and commercialization in Greater China and Southeast Asia. The active ingredient, roflumilast, is a highly active and selective phosphodiesterase-4 (PDE4) inhibitor, which reduces inflammation. Clinical studies conducted in China have demonstrated positive efficacy and good safety in patients aged 6 years and above.

The NMPA's acceptance is a significant milestone, enhancing Huadong Medicine's competitive edge in autoimmune skin disease treatment. The drug will now undergo review by the NMPA's Center for Drug Evaluation. However, the timing of the review, approval results, and future market competition remain uncertain, and investors are advised to consider the associated risks.