科笛-B(02487.HK)：CU-40102(外用非那雄胺噴霧劑)中國III期註冊性臨牀試驗達到主要終點
格隆匯9月7日丨科笛-B(02487.HK)發佈公吿，集團治療雄激素性脱髮產品CU-40102(外用非那雄胺噴霧劑)在中國進行的III期註冊性臨牀試驗達到主要終點。CU-40102的III期註冊性臨牀試驗為一項多中心、隨機、雙盲、安慰劑對照的試驗，以評估CU-40102對中國成年男性雄激素脱髮患者的療效及安全性。
CU-40102在中國的III期註冊性臨牀試驗共入組270名中國成年男性雄激素性脱髮受試者，其中180名受試者被隨機分配在CU-40102組，90名受試者被分配在安慰劑組。受試者在24周的持續治療期內每天在頭皮局部外用給藥一次。
該臨牀試驗結果顯示，在療效方面，受試者在治療24周後，CU-40102組受試者的頂部禿髮目標區域內的總毛髮計數及終毛計數改善均顯著優於安慰劑組，達到主要終點指標和主要的次要終點指標，且療效從第12周起開始展現。安全性方面，CU-40102受試者對給藥部位局部耐受性良好，CU-40102組與安慰劑組不良事件的總體發生率相似。CU-40102在中國的III期註冊性臨牀試驗的療效及安全性結果亦與境外臨牀結果相似。
與此同時，同期進行的一項CU-40102在中國成年男性雄激素脱髮患者中的I期藥代動力學研究顯示，非那雄胺噴霧劑給藥後，中國雄激素脱髮患者羣全身吸收量極少。
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，也是目前中國唯一處於臨牀階段的外用非那雄胺產品。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，從而可能減少口服藥常會引起的副作用。
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