李氏大藥廠(00950.HK)：一款在研皮膚治療產品預期將於下半年提交新藥申請
格隆匯4月14日丨李氏大藥廠(00950.HK)發佈公告，2020年4月7日，公司間接非全資附屬公司China Ophthalmology Focus Limited(“COPFL”)於中國在其用於治療中度尋常型痤瘡的阿達帕林－克林黴素組合凝膠(“ACCG”)的關鍵第III期臨牀試驗中，其最後一名(共1,617名)入組患者已完成最終研究回訪。目前正在進行臨牀數據收集及分析，預期將於2020年5月╱6月公佈主要數據，惟前提是成功鎖定數據庫及通過結果驗證，且預期將於2020年下半年提交新藥申請。
ACCG第III期多中心、隨機、單盲、平行、陽性對照研究(clinicaltrials.gov註冊編號：NCT03615768)旨在評估ACCG治療中度尋常型痤瘡的療效及安全性。先前第II期研究結果表明，0.1%阿達帕林+1%克林黴素乃治療尋常型痤瘡的最佳組合，並在該第III期研究中用作實驗組。該組合凝膠通過結合使用兩種具有不同作用機理的藥物及增加克林黴素的吸收來產生協同效應。
該第III期臨牀試驗的設計乃繼2017年成功完成第II期研究後與中國藥品審評中心協商達致。該項研究涉及28個臨牀試驗中心，在中國共入組1,617名患者，其中包括95名12至18歲青少年患者。該項研究共設立三個干預組，組內患者分別接受以下治療：i)每晚使用一次0.1%阿達帕林及1%克林黴素的組合凝膠，或ii)每晚使用一次0.1%阿達帕林凝膠，或iii)每天使用兩次磷酸克林黴素1%凝膠。治療時間為期12周，且於研究期間已測量療效及安全性參數。主要終點指標為病變計數相對基線的百分比變動與治療結束時(第85±3天)研究者整體評估量表減2分的綜合結果。已對樣本量進行計算，以檢測組合凝膠相對於兩個單獨分組的療效優勢。
阿達帕林－克林黴素組合凝膠乃COPFL一種用於治療中度尋常性痤瘡的在研專有產品。阿達帕林為一種RAR激動劑，可刺激皮膚生長，而克林黴素為一種可阻斷細菌蛋白質合成的抗生素。阿達帕林及克林黴素具有不同的作用機制，在尋常痤瘡治療中，相信將兩種藥物結合使用的療效會較單獨使用更佳。
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