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亞虹醫藥(688176.SH):APL-1702(鹽酸氨酮戊酸己酯軟膏光動力治療系統)的上市申請獲得受理
格隆匯 05-12 15:49

格隆匯5月12日丨亞虹醫藥(688176.SH)公佈,公司近日收到國家藥品監督管理局(NMPA)核准簽發的《受理通知書》,公司產品APL-1702(通用名:鹽酸氨酮戊酸己酯軟膏光動力治療系統)擬用於治療18歲及以上排除原位癌的經組織學證實的宮頸高級別鱗狀上皮內病變(High-Grade Squamous IntraepithelialLesion, HSIL)患者的上市申請獲得受理。

APL-1702經國家藥品監督管理局屬性界定為以藥品為主的藥械組合產品,其中,藥品部分是鹽酸氨酮戊酸己酯軟膏,器械部分是陰道內宮頸光動力治療燈。APL-1702 是藥械組合光動力治療產品,作為潛在的一種局部非手術治療方法,用於宮頸高級別鱗狀上皮內病變(HSIL)患者。

APL-1702 Ⅲ期臨牀試驗是一項前瞻、隨機、雙盲、安慰劑對照的國際多中心Ⅲ期臨牀試驗(以下簡稱“本研究”),目的是評估APL-1702 對宮頸高級別鱗狀上皮內病變(HSIL)的療效及安全性。本研究由中國醫學科學院北京協和醫院郎景和院士擔任主要研究者,來自中國、德國、荷蘭等多個國家的402名符合條件的患者隨機化後入組本研究。已完成的統計分析結果顯示,本研究已達到主要療效終點,安全性良好。

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