開拓藥業-B(09939.HK):福瑞他恩(KX-826)痤瘡臨牀試驗獲國家藥監局批准
格隆匯9月18日丨開拓藥業-B(09939.HK)宣佈,於2020年9月17日,公司福瑞他恩(KX826)凝膠劑型痤瘡適應症的新藥研究(IND)申請獲得中國國家藥品監督管理局批准。
痤瘡是一種慢性炎症性皮膚病,以開放或閉合的粉刺及炎性病變(如丘疹、膿皰或結節)為特點。痤瘡是一種常見疾病,特別是在青少年及年輕人中。痤瘡發病機制複雜,雄激素及其受體信號通路對皮脂腺及皮脂分泌的影響是引起痤瘡的重要因素之一。中國目前尚無有效的局部雄激素受體(AR)抑制劑可用於痤瘡的治療,市場未被滿足的臨牀需求很大。
福瑞他恩凝膠是靶點明確的外用雄激素受體拮抗劑,其通過競爭性抑制皮膚組織內的雄激素與雄激素受體相結合,能夠局部控制雄激素過高所引起受體信號通路的激活而不改變人體內雄激素受體信號通路的活性。通過塗抹給藥的作用方式,福瑞他恩凝膠可抑制毛囊皮脂腺中的雄激素受體與雄激素的結合,從而實現痤瘡的治療。於2020年8月,美國食品藥品監督管理局批准了同靶點的痤瘡治療新藥,是痤瘡治療40年來獲批的創新藥物,已經驗證該作用機制可以很好地治療痤瘡。
福瑞他恩已於2020年8月在美國完成雄激素脱髮的Ib期臨牀試驗並且目前正在中國進行雄激素脱髮的II期臨牀試驗。此次福瑞他恩凝膠獲得中國IND批准,進一步夯實了集團的臨牀管線,有望拓展痤瘡藥物的巨大市場。集團預期將於2021年第一季度就使用福瑞他恩凝膠治療痤瘡適應症展開首次患者招募。
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