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]

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]

Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical, received acceptance for the marketing application of Roflumilast cream (ZORYVE®) 0.15% from the National Medical Products Administration (NMPA) in China, indicating a significant step towards market entry for this treatment for atopic dermatitis [1] Group 1 - ZORYVE® contains Roflumilast, a highly selective non-steroidal phosphodiesterase-4 (PDE4) inhibitor, which helps reduce inflammation by inhibiting the production of pro-inflammatory mediators [1] - The Phase III clinical trial results in China demonstrated positive efficacy and good safety for ZORYVE® 0.15% in patients aged 6 years and older with mild to moderate atopic dermatitis, achieving the primary endpoint [1] - The efficacy and safety data from the Chinese study are similar to those from overseas studies conducted by the partner company, Arcutis, supporting the domestic application for market approval [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 the 0.3% foam formulation is approved for seborrheic dermatitis in patients aged 9 years and older and for plaque psoriasis in patients aged 12 years and older [2]