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李氏大藥廠(00950.HK)肺動脈高壓治療藥物曲前列環素注射溶液獲藥品註冊批件
格隆匯 03-19 19:08

格隆匯3月19日丨李氏大藥廠(00950.HK)發佈公告,2020年3月18日,公司全資附屬公司兆科藥業(合肥)有限公司開發用於治療肺動脈高壓(“PAH”)的藥物-曲前列環素注射溶液已自中華人民共和國(「中國」)國家藥品監督管理局獲得生產及上市批文。曲前列環素注射溶液的簡略新藥申請(ANDA)已於2019年6月提交,而該申請已獲授予優先審評資格。國家藥監局授予的上述批文使得兆科合肥的曲前列環素成為首仿可於中國廣泛供應。

根據披露,曲前列環素注射溶液為一種通過皮下或靜脈注射的前列線環素類似物,用於治療世界衞生組織第1組PAH患者,以減少與運動相關的症狀並提高運動能力。其適用於患有紐約心臟學會(“NYHA”)功能分類第二、三或四級的PAH嚴重患者。設立有效的研究涵蓋具有NYHA功能分類第二至第四級症狀及先天性或遺傳性PAH病因、伴隨先天性體肺分流的PAH或伴隨結締組織病的PAH的患者。

公告表示,集團透過於2014年註冊《瑞莫杜林》(最初由美國United Therapeutics(聯合制藥)開發及銷售的曲前列環素)首次向中國患者供應曲前列環素。在過去五年,集團已建立專業團隊及專用基礎設施為中國PAH患者提供服務及解決未得到滿足的醫療需求。就PAH嚴重患者而言,《瑞莫杜林》已成為首選治療方案,受到醫生及患者的一致好評。然而,由於產品的性質使然,產品成本令若干患者難以開始及╱或繼續治療。

根據南方網的資料顯示,中國約500萬至800萬的PAH患者(包括該等伴隨先天性心臟病及其他慢性病的PAH患者)中僅有約1萬至2萬名PAH患者接受過治療。集團預期為PAH患者提供價格合理的曲前列環素注射溶液將為釋放其市場潛力創造更多機會。

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