开拓药业-B(09939.HK):福瑞他恩(KX-826)痤疮临床试验获国家药监局批准
格隆汇9月18日丨开拓药业-B(09939.HK)宣布,于2020年9月17日,公司福瑞他恩(KX826)凝胶剂型痤疮适应症的新药研究(IND)申请获得中国国家药品监督管理局批准。
痤疮是一种慢性炎症性皮肤病,以开放或闭合的粉刺及炎性病变(如丘疹、脓疱或结节)为特点。痤疮是一种常见疾病,特别是在青少年及年轻人中。痤疮发病机制复杂,雄激素及其受体信号通路对皮脂腺及皮脂分泌的影响是引起痤疮的重要因素之一。中国目前尚无有效的局部雄激素受体(AR)抑制剂可用于痤疮的治疗,市场未被满足的临床需求很大。
福瑞他恩凝胶是靶点明确的外用雄激素受体拮抗剂,其通过竞争性抑制皮肤组织内的雄激素与雄激素受体相结合,能够局部控制雄激素过高所引起受体信号通路的激活而不改变人体内雄激素受体信号通路的活性。通过涂抹给药的作用方式,福瑞他恩凝胶可抑制毛囊皮脂腺中的雄激素受体与雄激素的结合,从而实现痤疮的治疗。於2020年8月,美国食品药品监督管理局批准了同靶点的痤疮治疗新药,是痤疮治疗40年来获批的创新药物,已经验证该作用机制可以很好地治疗痤疮。
福瑞他恩已于2020年8月在美国完成雄激素脱发的Ib期临床试验并且目前正在中国进行雄激素脱发的II期临床试验。此次福瑞他恩凝胶获得中国IND批准,进一步夯实了集团的临床管线,有望拓展痤疮药物的巨大市场。集团预期将于2021年第一季度就使用福瑞他恩凝胶治疗痤疮适应症展开首次患者招募。
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