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開拓藥業-B(09939.HK):KX-826治療男性脱髮中國III期臨牀試驗結果
格隆匯 11-27 07:49

格隆匯11月27日丨開拓藥業-B(09939.HK)發佈公吿,KX-826外用治療男性雄激素性脱髮(“脱髮”或“AGA”)的中國III期臨牀試驗(“該項III期臨牀試驗”)已讀出頂線數據。該項III期臨牀試驗是一項多中心、隨機、雙盲、安慰劑對照的研究,以評估外用0.5%濃度每日使用兩次KX-826治療中國成年男性脱髮患者的有效性和安全性。該項研究的主要終點為24周結束時目標區域內非毳毛數(TAHC/cm2)對比基線的平均變化。安全性指標包括不良事件的發生類型、發生率和嚴重程度。

分析結果顯示,該試驗整體安全性優良,KX-826展示了極佳的安全性能,試驗過程未報吿任何重大不良反應。治療24周後,KX-826組TAHC結果顯示,KX-826與基線相比促進了毛髮生長,具有統計學意義(P<0.0001)。與安慰劑相比,KX-826組TAHC在各個訪視點均有提高,差異在統計學上未達到顯着性,但顯示療效趨勢。公司將繼續分析該項III期臨牀試驗的結果,並開展KX-826外用治療脱髮及痤瘡的多項臨牀試驗,持續探索KX-826上市的可能性。

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