Huadong Medicine's psoriasis drug application accepted by NMPA

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a subsidiary of Huadong Medicine, announced on October 30, 2025, that its application for Roflumilast Cream (ZORYVE®) 0.3% was accepted by the National Medical Products Administration (NMPA). This marks a significant milestone for the drug, classified as a Chemical Drug 5.1, indicated for the topical treatment of plaque psoriasis in patients aged 6 years and older. The application seeks a market license for the imported product.

Roflumilast Cream, an innovative topical formulation, is a highly selective phosphodiesterase-4 (PDE4) inhibitor. Huadong Medicine secured exclusive rights for development, registration, production, and commercialization in Greater China and Southeast Asia through a 2023 partnership with Arcutis Biotherapeutics, Inc. Clinical trial results in China's Phase II showed positive efficacy and safety for the 0.3% concentration in treating plaque psoriasis.

The acceptance of the application signifies a crucial step in the drug's journey towards market availability, enhancing Huadong Medicine's competitive edge in the autoimmune skin disease treatment sector. The company will proceed with NMPA review, with final approval contingent upon the drug's safety and efficacy profile, as well as adherence to regulatory standards.