歌禮制藥-B(01672.HK)在2025年EADV年會上報告了同類首創脂肪酸合成酶(FASN)抑制劑地尼法司他(ASC40)治療痤瘡的III期研究結果
格隆匯9月18日丨歌禮制藥-B(01672.HK)宣佈,在2025年9月17日於法國巴黎舉行的2025年歐洲皮膚病與性病學會(EADV)年會最新突破性研究專場上口頭報告了地尼法司他(denifanstat,ASC40)治療中重度尋常性痤瘡的III期研究(NCT06192264)結果。
根據披露,地尼法司他(denifanstat,ASC40)達到所有主要、關鍵次要及次要療效終點(意向治療集(ITT)分析),與安慰劑相比顯著改善中重度痤瘡。地尼法司他(ASC40)顯示出了良好的安全性與耐受性特徵。地尼法司他(ASC40)組和安慰劑組的治療期間發生的不良事件(TEAE)發生率相當:58.6%對比56.3%。大部分TEAE爲輕度(1級)或中度(2級)。
歌禮正與中國國家藥品監督管理局(NMPA)進行地尼法司他(ASC40)的上市申請前(Pre-NDA)溝通,NMPA目前反饋良好。歌禮計劃在完成上市申請前溝通後向NMPA提交地尼法司他(ASC40)用於治療中重度尋常性痤瘡的新藥上市申請(NDA)。
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