開拓藥業-B(09939.HK):KX-826酊1.0%治療中國成年男性雄激素性脱髮的臨牀試驗獲NMPA批准
格隆匯5月24日丨開拓藥業-B(09939.HK)宣佈,其自主研發、潛在同類首創的KX-826酊1.0%治療中國成年男性雄激素性脱髮("AGA")的臨牀試驗("該項臨牀試驗")已於近日獲得國家藥品監督管理局("NMPA")批准,用以評價KX-826酊1.0%外用治療中國成年男性AGA患者的有效性和安全性。公司的臨牀前研究顯示,相對之前III期臨牀試驗所用的KX-826酊0.5%劑型,該酊1.0%劑型在人體頭皮細胞上的留存濃度顯著增加,有望提升臨牀效果。
KX-826為集團的核心藥物之一,自開發以來已在中國、美國完成針對男性及女性的多項用於脱髮治療的臨牀試驗,並表現出優異的安全性及有效性趨勢。集團將進一步挖掘KX-826於脱髮領域的治療效果。同時,集團正在開展和計劃啟動KX-826用於治療脱髮及痤瘡的多項臨牀試驗,持續開發KX-826於皮科領域的使用價值。
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