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步長製藥(603858.SH):控股子公司藥品鹽酸克林黴素膠囊通過仿製藥一致性評價
格隆匯 05-09 18:10

格隆匯5月9日丨步長製藥(603858.SH)公佈,公司於近日獲悉,公司控股子公司邛崍天銀製藥有限公司收到國家藥品監督管理局核准簽發的關於鹽酸克林黴素膠囊的《藥品補充申請批准通知書》。該藥品通過工藝處方變更的仿製藥質量和療效一致性評價。

克林黴素適用於由敏感厭氧菌引起的嚴重感染。克林黴素適用於由鏈球菌、肺炎球菌和葡萄球菌等敏感菌株引起的嚴重感染,但僅適用於對青黴素過敏的患者或經醫生判斷不宜使用青黴素的患者。由於存在結腸炎風險,醫生在選用克林黴素前,應先考慮感染的嚴重程度以及有無毒性較低的替代藥(如紅黴素)。

根據米內網數據,2019年至2021年中國(城市公立,城市社區,縣級公立,鄉鎮衞生)年度銷售趨勢顯示,鹽酸克林黴素膠囊銷售額依次為5255萬元、2851萬元、2120萬元。

截至目前,公司在該藥品一致性評價累計研發投入約為794.36萬元。

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