兆科眼科-B(06622.HK):一項發明獲得美國專利授權
格隆匯6月21日丨兆科眼科-B(06622.HK)宣佈,於2021年6月15日,公司一項早前已在中國獲得專利授權的發明"一種凝膠製劑中阿達帕林的分散工藝"(中國專利申請編號:201711392438.9)獲得美國專利商標局授予美國專利授權(美國專利申請編號:16228808)。
"一種凝膠製劑中阿達帕林的分散工藝"專利用於公司的候選產品阿達帕林鹽酸克林黴素複方凝膠("ACCG"),乃一種用於治療中度尋常型痤瘡的在研專利產品。阿達帕林為一種視黃酸受體(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之抗生素。
公司已成功完成ACCG在中國的關鍵第III期試驗。關鍵第III期試驗的主要數據表明該研究已達到主要終點指標,證明ACCG優於單獨使用阿達帕林凝膠或克林黴素凝膠,具有高度統計差異(P<0.0001)。與兩個單獨分組相比,ACCG在主要終點指標方面有明顯改善,ACCG組之基線相對總病變計數之百分比變動為68.5%,而阿達帕林凝膠組及磷酸克林黴素凝膠組分別為52.8%(P<0.0001)及59.5%(P<0.0001)。
於2021年2月,公司於中國提交的ACCG新藥上市申請已獲中國國家藥品監督管理局受理。
董事會認為,公司的發明是次獲得美國專利授權,象徵ACCG在美國市場銷售時將受到知識產權保護,有助保障公司在當地的利益。
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