Core Viewpoint - Huadong Medicine (000963) announced that its wholly-owned subsidiary, Sino-American Huadong, received the Acceptance Notice from the National Medical Products Administration for the marketing application of ZORYVE® (0.15% Roflumilast Cream), which is intended for local treatment of mild to moderate atopic dermatitis in patients aged 6 and above [1] Group 1 - The marketing application for Roflumilast Cream has been accepted, indicating progress in the drug approval process [1] - The drug is specifically designed for local treatment of atopic dermatitis, targeting a significant patient demographic [1] - The acceptance by the National Medical Products Administration is a crucial step towards commercialization [1]

Core Viewpoint - Huadong Medicine (000963.SZ) announced that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., received the Acceptance Notification from the National Medical Products Administration (NMPA) for the marketing application of Roflumilast Cream (ZORYVE®) 0.15% on November 10, 2025 [1] Group 1 - 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 study results in China showed that Roflumilast Cream (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 Roflumilast Cream (ZORYVE®) are similar to the overseas research data from the partner Arcutis, supporting its application for domestic marketing [1] Group 2 - In the United States, ZORYVE® 0.05% cream is approved by the FDA for the treatment of mild to moderate atopic dermatitis in children aged 2 to 5 years [2] - ZORYVE® 0.15% cream is approved for local treatment of mild to moderate atopic dermatitis in patients aged 6 years and older [2] - ZORYVE® 0.3% cream is approved for local 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 in patients aged 12 years and older [2]