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罗氟司特乳膏(ZORYVE®)0.15%
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华东医药:子公司收到药品注册受理通知书
Xin Lang Cai Jing· 2025-11-11 10:51
Core Viewpoint - The company announced that its subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., received a Notice of Acceptance from the National Medical Products Administration (NMPA) for the marketing application of ZORYVE® (0.15% roflumilast cream) [1] Group 1: Product Development - The marketing application for ZORYVE® has been accepted, indicating progress towards commercialization in China [1] - Phase III clinical trial results demonstrate that ZORYVE® (0.15%) shows positive efficacy and good safety in patients aged 6 and above with mild to moderate atopic dermatitis [1] - The efficacy and safety data from the domestic study align with overseas research data from the partner company, Arcutis, supporting the application for market approval in China [1]