科笛-B(02487.HK):CU-40102(外用非那雄胺噴霧劑)新藥上市申請獲得國家藥監局受理
格隆匯1月31日丨科笛-B(02487.HK)發佈公吿,集團的CU-40102新藥上市申請(“NDA”)獲得中國國家藥品監督管理局(“國家藥監局”)受理。CU-40102的適應症為治療雄激素性脱髮。
CU-40102是全球首個亦是唯一一個獲批用於雄激素性脱髮治療的外用非那雄胺產品,也是中國首個獲得中國國家藥監局受理NDA的外用非那雄胺。非那雄胺作為特異性II型5α-還原酶競爭抑制劑抑制頭皮中睾酮轉化為雙氫睾酮,可治療男性患者的雄激素性脱髮。與口服非那雄胺不同,CU-40102的外用製劑便於患者將藥物直接精確地塗抹在頭皮表面,在用藥部位保持高濃度,減少藥物的全身暴露,從而可減少口服藥常會引起的副作用。
中國的III期註冊性臨牀試驗數據分析結果顯示,CU-40102能有效治療雄激素性脱髮,且CU-40102受試者對給藥部位局部耐受性良好。同期進行的一項CU-40102 在中國成年男性雄激素性脱髮患者中的I期藥代動力學研究顯示,非那雄胺噴霧劑給藥後,中國雄激素性脱髮患者羣全身吸收量極少。
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