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0.3%罗氟司特泡沫临床试验获批 华东医药加码皮肤炎症治疗领域
Zheng Quan Ri Bao· 2025-06-11 09:40
Core Viewpoint - Huadong Medicine Co., Ltd. announced the approval of a clinical trial for 0.3% roflumilast foam for seborrheic dermatitis, marking a significant step in its product development [2][3] Group 1: Product Development - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration (NMPA) for a Phase III clinical trial of 0.3% roflumilast foam [2] - Roflumilast foam is an innovative topical formulation introduced through a collaboration with Arcutis Biotherapeutics, Inc., with exclusive rights in Greater China and Southeast Asia [2] - The product has already been approved in the U.S. and Canada for local treatment of seborrheic dermatitis in patients aged 9 and older, representing the first new mechanism topical treatment approved in over 20 years [2] Group 2: Clinical Research Progress - The Phase III clinical studies for 0.15% and 0.3% roflumilast creams in China have commenced, with the first subject enrolled and treated in November 2024 [3] - The recent approval signifies a critical advancement in the development of this product line, potentially enhancing Huadong Medicine's core competitiveness in the fields of autoimmune and topical formulations [3]