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海正藥業(600267.SH):注射用達託黴素通過一致性評價
格隆匯 09-30 16:57

格隆匯9月30日丨海正藥業(600267.SH)公佈,近日,公司收到國家藥監局核准簽發的注射用達託黴素的《藥品補充申請批准通知書》,公司藥品注射用達託黴素已通過仿製藥質量和療效一致性評價。

注射用達託黴素適用於治療:1、成人和小兒患者(1至17歲)的複雜皮膚和皮膚結構感染(cSSSI);2、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);3、小兒患者(1至17歲)的金黃色葡萄球菌血流感染(菌血症)。原研藥Cubicin for injection,500mg/支由Cubist Pharmaceuticals LLC公司研發。目前,注射用達託黴素國內主要生產廠商有杭州中美華東製藥有限公司、浙江海正藥業股份有限公司等。

據統計,注射用達託黴素2021年全球銷售額約為36,856.50萬美元,其中國內銷售額約為1257.05萬美元;2022年1-6月全球銷售額約為17,181.06萬美元,其中國內銷售額約為629.11萬美元(數據來源於IMS數據庫)。公司注射用達託黴素近三年未實現銷售。

2021年8月19日,國家藥監局受理了公司遞交的注射用達託黴素一致性評價申請。截至目前,公司針對該藥品仿製藥質量和療效一致性評價已投入約1146萬元人民幣。

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