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恆瑞醫藥(600276.SH):格隆溴銨注射液獲藥品註冊證書
格隆匯 10-09 15:41

格隆匯 10 月 9日丨恆瑞醫藥(600276.SH)公佈,公司近日收到國家藥品監督管理局核准簽發的《藥品註冊證書》,藥品名稱為格隆溴銨注射液。

2018525日,恆瑞醫藥向國家食品藥品監督管理總局遞交的藥品註冊申請獲得受理,2018911日,公司格隆溴銨注射液進入國家食品藥品監督管理總局藥品審評中心公佈的擬納入優先審評程序藥品註冊申請的公示名單(第三十二批),優先審評理由:與現有治療手段相比具有明顯治療優勢。格隆溴銨注射液是一種抗膽鹼能藥物。當逆轉非去極化肌肉鬆弛劑誘導的神經肌肉阻滯時,該藥品可拮抗膽鹼能藥物,如新斯的明的外周毒蕈鹼作用。

格隆溴銨注射液由Baxter Healthcare公司開發,19752月在美國獲批上市銷售,商品名為Robinul®,規格為0.2mg/ml,目前格隆溴銨注射液在英國、加拿大、澳大利亞等國家已批准上市。經查詢,目前國內已有格隆溴銨片及格隆溴銨吸入粉霧劑膠囊獲批上市,尚未有該藥品注射劑獲批上市。除公司外,另有江蘇海岸、成都苑東、廣東嘉博提交ANDA申請,目前未見獲批信息,公司為國內首家獲批上市格隆溴銨注射液的企業。

截至目前,該產品累計已投入研發費用約1489萬元人民幣。

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