健友股份(603707.SH):子公司產品注射用達託黴素獲美國FDA藥品註冊批件
格隆匯6月30日丨健友股份(603707.SH)公佈,公司子公司香港健友實業有限公司(“香港健友”)於近日收到美國FDA簽發的注射用達託黴素,500mg/瓶(ANDA號:213623),350mg/瓶(ANDA號:213786)批准信。
注射用達託黴素適應於成人和兒童患者(1至17歲)的複雜皮膚和皮膚結構感染(cSSSI);成年患者(包括患有右側感染性心內膜炎的患者)的金黃色葡萄球菌血流感染(菌血症);兒童患者(1至17歲)的金黃色葡萄球菌血流感染(菌血症)。
達託黴素是由Lilly(禮來)公司最初研究,CUBIST PHARMS LLC開發的環脂肽類抗生素。2003年9月,美國FDA首次批准注射用達託黴素(500mg/瓶)上市,商品名為Cubicin®,臨牀用於治療複雜性皮膚及皮膚軟組織感染與金黃色葡萄球菌引起的菌血症,目前注射用達託黴素已在全球廣泛上市銷售。
截至目前,公司在注射用達託黴素研發項目上已投入研發費用約人民幣1905.20萬元。
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