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翰宇藥業(300199.SZ):醋酸阿託西班注射液獲西班牙藥品上市許可
格隆匯 02-16 18:09

格隆匯2月16日丨翰宇藥業(300199.SZ)公佈,公司近日收到通知,公司的醋酸阿託西班注射液獲得西班牙藥品和健康產品局批准的上市許可,成為公司首個在歐盟國家獲得上市許可的製劑產品。

醋酸阿託西班注射液適用於有下列情況的妊娠婦女,以推遲即將來臨的早產:1、每次至少30秒的規律子宮收縮,每30分鐘內≥4次;2、宮頸擴張1~3cm(初產婦0~3cm)和子宮軟化度/變薄≥50%;3、妊娠24至33足周;4、年齡≥18;5、胎心率正常。

阿託西班是子宮內及蜕膜、胎膜上受體的催產素競爭性拮抗劑。使用本品後可劑量相關性地抑制宮縮,並使催產素介導的前列腺素分泌減少,達到保胎的目的。

醋酸阿託西班注射液的原研企業為Ferring Pharmaceuticals(輝凌製藥),2000年1月20日在歐洲獲批上市,商品名Tractocile(中文名:依保),目前已在歐洲、中國、俄羅斯等地上市銷售,根據IQVIA數據庫顯示,2019年全球銷售額為5866.22萬美元。

醋酸阿託西班作為目前歐洲藥物總署批准用於治療早產的唯一具有子宮特異性的宮縮抑制劑,優點是保胎效果好,對母體及胎兒安全性高,早於2007年歐洲早產指南就建議阿託西班用於抗早產一線用藥。

公司的醋酸阿託西班注射液除本次在西班牙獲批外,2019年12月在國內獲批上市。

此次醋酸阿託西班注射液獲得西班牙的藥品上市許可標誌着公司具備了在西班牙市場銷售該藥品的資格,成為公司首個獲得歐盟國家上市許可的藥品,對公司市場拓展帶來積極影響,有利於提升公司的國際品牌影響力,公司將積極推動該藥品的上市銷售。

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