Huadong Medicine Co., Ltd. (000963.SZ) announced on November 10, 2025, that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., received the "Acceptance Notice" (Acceptance No.: JXHS2500126) from the National Medical Products Administration (NMPA) for the marketing authorization application of Roflumilast Cream (ZORYVE®) 0.15%.
ZORYVE®'s active ingredient, roflumilast, is a highly potent and selective non-steroidal phosphodiesterase-4 (PDE4) inhibitor. PDE4 is an intracellular enzyme that increases pro-inflammatory mediators and reduces anti-inflammatory mediators. Inhibiting PDE4 can alleviate inflammatory responses.
Results from China's Phase III clinical study demonstrated that Roflumilast Cream (ZORYVE®) 0.15% showed positive efficacy and favorable safety in subjects aged 6 and above with mild to moderate atopic dermatitis, meeting the primary endpoint. The overall effectiveness and safety data were consistent with overseas research data from partner Arcutis, supporting its domestic market application.
Currently, in the U.S., ZORYVE® 0.05% cream is FDA-approved for topical treatment of mild to moderate atopic dermatitis in pediatric patients aged 2 to 5, while ZORYVE® 0.15% cream is approved for patients aged 6 and above. Additionally, ZORYVE® 0.3% cream is approved for plaque psoriasis in patients aged 6 and above, and ZORYVE® 0.3% foam is approved for seborrheic dermatitis in patients aged 9 and above, as well as scalp and body plaque psoriasis in patients aged 12 and above.
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