罗氟司特乳膏(ZORYVE)0.05%
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华东医药创新皮肤外用制剂罗氟司特乳膏0.05%上市许可申请获NMPA受理
Mei Ri Jing Ji Xin Wen· 2026-02-04 01:45
Core Viewpoint - Huadong Medicine's subsidiary has received acceptance for the marketing application of ZORYVE, indicating progress in its product pipeline for treating atopic dermatitis in young children [1] Group 1: Company Developments - Huadong Medicine's wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., has received the acceptance notice from the National Medical Products Administration (NMPA) for the marketing application of ZORYVE 0.05% [1] - The application is specifically for the indication of local external treatment for mild to moderate atopic dermatitis in patients aged 2 to 5 years [1]
华东医药:全资子公司收到罗氟司特乳膏上市许可申请受理通知书
Mei Ri Jing Ji Xin Wen· 2026-02-03 10:24
Core Viewpoint - Huadong Medicine (000963.SZ) announced that its wholly-owned subsidiary, Sino-American Huadong, received the Acceptance Notice from the National Medical Products Administration for the marketing application of ZORYVE (0.05% Roflumilast Cream), aimed at treating mild to moderate atopic dermatitis in patients aged 2 to 5 years [1] Group 1: Product Development - The drug is a collaborative innovation between Sino-American Huadong and Arcutis Biotherapeutics, Inc., with exclusive rights in Greater China and Southeast Asia [1] - Roflumilast cream offers safety advantages over traditional treatment methods and can be applied to all body parts with once-daily dosing, enhancing treatment adherence [1] Group 2: Market Positioning - The acceptance of the marketing application represents a significant milestone in the product development process, which will enhance the company's core competitiveness in the autoimmune skin treatment sector [1] - There are uncertainties regarding the drug review and approval timeline, approval outcomes, and future market competition dynamics [1]