華東醫藥(000963.SZ):中美華東的0.3%羅氟司特泡沫(ZORYVE®)的III期臨牀試驗申請獲得批准
格隆匯6月10日丨華東醫藥(000963.SZ)公佈,2025年6月9日,華東醫藥股份有限公司全資子公司杭州中美華東製藥有限公司(簡稱“中美華東”)收到國家藥品監督管理局(NMPA)核准簽發的一項《藥物臨牀試驗批准通知書》(通知書編號:2025LP01513),由中美華東申報的一項評價0.3%羅氟司特泡沫(ZORYVE®)在脂溢性皮炎患者中有效性和安全性的多中心、隨機、雙盲、賦形劑平行對照的III期臨牀試驗申請獲得批准。
羅氟司特泡沫在緩解脂溢性皮炎的關鍵症狀和體徵方面表現出顯著療效,此外,它保持了良好的安全性和耐受性,其應用部位反應近80%的患者在第8周時達到完全或接近完全清除。該產品是FDA二十多年來首個批准的具有新作用機制的脂溢性皮炎外用藥物,有望為脂溢性皮炎患者帶來新的治療選擇。
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