Core Viewpoint - East China Pharmaceutical (华东医药) announced that its wholly-owned subsidiary, Hangzhou Zhongmei East Pharmaceutical Co., Ltd., received a Notice of Acceptance from the National Medical Products Administration (NMPA) for the marketing application of Roflumilast cream (ZORYVE) 0.15% on November 10, 2025 [1] Group 1: Product Information - Roflumilast, the active ingredient in ZORYVE, 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 study 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 company, Arcutis, supporting its domestic application for marketing [1] Group 2: Regulatory Approvals - 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 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 of the scalp and body in patients aged 12 years and older [2]