麗珠醫藥(01513.HK)子公司獲得藥品註冊批件
格隆匯12月23日丨麗珠醫藥(01513.HK)公佈,近日,公司全資子公司麗珠集團麗珠製藥廠收到國家藥品監督管理局核准簽發的《藥品註冊批件》(批件號:2019S00681)。該藥品通用名稱為注射用鹽酸萬古黴素,規格為0.5g,有效期為18個月。
注射用鹽酸萬古黴素是公司自主研發的產品,適應症為:1、該品適用於治療對萬古黴素敏感的耐甲氧西林(β-內酰胺耐藥)的葡萄球菌引起的嚴重或致命感染;2、該品對治療葡萄球菌所導致的心內膜炎有效;3、單獨使用該品或是並用氨基糖苷類治療由草綠色鏈球菌或牛鏈球菌所引起的心內膜炎,效果均佳;4、類白喉桿菌引起的心內膜炎,使用萬古黴素治療有效。該產品主要通過抑制細胞壁的生物合成發揮殺菌作用。另,萬古黴素能改變細菌細胞膜的通透性和RNA合成,和其他抗生素之間不會發生交叉耐藥性。公司首次提交該品生產申請的受理時間為2013年07月17日(受理號:CYHS1301080粵)。
截至公告日,注射用鹽酸萬古黴素累計直接投入的研發費用約為人民幣691.01萬元。
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