普利製藥(300630.SZ):注射用泮托拉唑鈉獲得加拿大衞生部批准
格隆匯6月3日丨普利製藥(300630.SZ)公佈,公司於近日收到加拿大衞生部簽發的注射用泮托拉唑鈉批准通知。
注射用泮托拉唑鈉是一種選擇性的長效質子泵抑制劑。其分子由苯並咪唑通過亞碸基連接吡啶環組成,在中性和弱酸性條件下相對穩定,在強酸性條件下迅速活化,從而對H+、K+-ATP酶具有更好的選擇性。本品能特異性地抑制壁細胞頂端膜構成的分泌性微管和胞漿內的管狀泡上的H+、K+-ATP酶,引起該酶不可逆性的抑制,從而有效地抑制胃酸的分泌。適用於活動性消化性潰瘍(胃、十二指腸潰瘍),反流性食管炎和卓-艾氏綜合徵。
注射用泮托拉唑鈉於2001年3月率先由Wyeth公司(Takeda授權)在美國獲準上市,商品名為PROTONIX,劑型為注射劑,規格為40mg。注射用泮托拉唑鈉目前已在全球廣泛上市銷售。
公司成功研發該產品後,已相繼提交了國內外多個市場的註冊申請。於2017年2月、3月本品已分別在荷蘭和德國獲得批准上市,2018年8月在澳大利亞批準上市。於近日,收到了加拿大衞生部的批准通知。
注射用泮托拉唑鈉註冊申請獲得加拿大衞生部批准標誌着普利製藥的注射用泮托拉唑鈉具備了在加拿大銷售的資格,將對公司拓展加拿大市場帶來積極影響。
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