华东医药罗氟司特乳膏上市许可申请获得受理

Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., has received a notice of acceptance from the National Medical Products Administration for the marketing application of ZORYVE (0.15% Roflumilast Cream) [1] Group 1: Product Development - Roflumilast cream is an innovative topical formulation introduced through a collaboration agreement signed in August 2023 between Huadong Medicine's subsidiary and Arcutis Biotherapeutics, Inc. [1] - The subsidiary holds exclusive rights for the product in Greater China (including mainland China, Hong Kong, Macau, and Taiwan) and Southeast Asia (including Indonesia, Singapore, the Philippines, Thailand, Myanmar, Brunei, Cambodia, Laos, Malaysia, and Vietnam) [1] Group 2: Regulatory Milestones - The acceptance of the marketing application by the National Medical Products Administration marks a significant regulatory milestone for the company [1] - This step is crucial for the development, registration, production, and commercialization of the product in the specified regions [1]