普洛藥業(000739.SZ):子公司獲得關於琥珀酸美託洛爾緩釋片的藥品註冊證書
格隆匯10月12日丨普洛藥業(000739.SZ)公佈,近日,公司全資子公司浙江巨泰藥業有限公司收到國家藥品監督管理局核准簽發的關於琥珀酸美託洛爾緩釋片的《藥品註冊證書》,適應症:高血壓;心絞痛;伴有左心室收縮功能異常的症狀穩定的慢性心力衰竭。
美託洛爾是全球首個選擇性β1受體阻滯劑,可降低支氣管收縮風險,因而
成為慢性心衰常用藥物。琥珀酸美託洛爾緩釋片為治療高血壓、心絞痛、伴有左心室收縮功能異常的症狀穩定的慢性心力衰竭等適應症的藥物。
據米內網數據顯示,美託洛爾製劑2019年和2020年在國內城市公立醫院、
縣級公立醫院及鄉鎮衞生院終端銷售總額分別為273,403萬元和296,577萬元。
其中琥珀酸美託洛爾緩釋片銷售金額分別為200,814萬元和223,530萬元。
截止目前,公司用於開展琥珀酸美託洛爾緩釋片項目累計投入研發費用約2066萬元。
根據國家藥監局《關於仿製藥質量和療效一致性評價工作有關事項的公吿》(2017 年第 100
號)文件相關規定,此藥品視為通過仿製藥質量和療效一致性評價。截止目前,公司為國內第四家通過琥珀酸美託洛爾緩釋片一致性評價的企業。該產品是公司中美雙報品種,目前美國申報正處於待上市前官方現場檢查階段。
該註冊證書的取得有利於實現公司原料藥製劑一體化戰略,標誌着公司取得了參加該產品後續集採的資格,可以進一步提升該產品的市場競爭力,對公司經營發展具有一定的積極作用。
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