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华东医药创新皮肤外用制剂罗氟司特乳膏两项Ⅲ期临床试验完成首例受试者入组

Huadong Medicine's innovative topical formulation, Roflumilast cream, has completed the first subject enrollment for two Phase III clinical trials.

Breakings ·  Dec 18 09:11

Recently, Huadong Medicine's wholly-owned subsidiary, Hangzhou Zhimai Huadong Pharmaceutical Co., Ltd. (referred to as "Zhimai Huadong"), conducted a multicenter, randomized, double-blind, excipient-controlled Phase III bridging study evaluating the efficacy and safety of 0.15% Roflumilast cream (ZORYVE) in patients with mild to moderate atopic dermatitis, completing the first subject enrollment and administration at Huashan Hospital affiliated with SHANGHAI FUDAN University; a multicenter, randomized, double-blind, excipient-controlled Phase III clinical study evaluating the efficacy and safety of 0.3% Roflumilast cream (ZORYVE) for the treatment of plaque psoriasis in China has also completed its first subject enrollment and administration at Peking University People's Hospital. Roflumilast cream is an innovative topical formulation product introduced through a cooperation agreement signed in August 2023 between Zhimai Huadong and Arcutis, a company listed on the Nasdaq in the USA, and Zhimai Huadong holds exclusive rights to this product in Greater China and Southeast Asia.

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