华东医药：罗氟司特乳膏(ZORYVE)0.15%上市许可申请获得受理

Core Viewpoint - Huadong Medicine (000963.SZ) announced that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., received the acceptance notice from the National Medical Products Administration (NMPA) for the marketing authorization application of Roflumilast cream (ZORYVE) 0.15% on November 10, 2025 [1] Group 1 - ZORYVE's active ingredient, Roflumilast, is a highly active and selective non-steroidal phosphodiesterase-4 (PDE4) inhibitor, which can reduce inflammation by inhibiting the production of pro-inflammatory mediators [1] - The Phase III clinical trial results in China showed that ZORYVE 0.15% demonstrated positive efficacy and good safety in subjects aged 6 years and older with mild to moderate atopic dermatitis, achieving the primary endpoint [1] - The overall efficacy and safety data of ZORYVE in China are similar to the overseas research data from the partner Arcutis, supporting its domestic application for marketing [1] Group 2 - In the United States, ZORYVE 0.05% cream is approved by the FDA for the topical treatment of mild to moderate atopic dermatitis in children aged 2 to 5 years [2] - ZORYVE 0.15% cream is approved for the topical treatment of mild to moderate atopic dermatitis in patients aged 6 years and older [2] - ZORYVE 0.3% cream is approved for the topical treatment of plaque psoriasis in patients aged 6 years and older, while ZORYVE 0.3% foam is approved for seborrheic dermatitis in patients aged 9 years and older and for plaque psoriasis on the scalp and body in patients aged 12 years and older [2]