復旦張江(688505.SH):鹽酸氨酮戊酸外用散用於治療光化性角化病的藥物臨牀試驗申請獲受理
格隆匯10月14日丨復旦張江(688505.SH)公佈,公司於近日收到國家藥品監督管理局核准簽發的《受理通知書》,鹽酸氨酮戊酸外用散(以下簡稱“該藥物”)用於治療面部和頭皮處輕度至中度的光化性角化病(ActinicKeratosis,簡稱“AK”)的藥物Ⅱ期臨牀試驗申請獲得受理。
AK又稱光線性角化病,日光性角化病、老年性角化病,是一種因不典型表皮角質形成細胞增生而引起的一種癌前皮膚病變。其多發於面部、頭皮或手背等曝光部位,好發於中老年人。我國現有治療方案包括冷凍、刮除、外用藥物塗抹等。
採用光動力療法治療AK在國外已有獲批先例,美國食品藥品監督管理局分別於1999年12月和2016年5月批准兩款含鹽酸氨酮戊酸成分的藥品(商品名:LEVULAN®KERASTICK®和AMELUZ®)上市。前述藥品與特定光動力治療儀聯用,是國外治療位於頭頸部的多個病灶AK的首選療法之一。經研究發現,公司光動力平台之藥品鹽酸氨酮戊酸外用散亦可拓展應用於AK的臨牀治療。
據悉,公司此次向國家藥監局註冊申請事項為境內已上市化學藥品鹽酸氨酮戊酸外用散(商品名:艾拉®)增加新適應症的藥物Ⅱ期臨牀試驗申請。
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