景峯醫藥(000908.SZ):子公司獲得伏立康唑片的藥品註冊證書
格隆匯10月12日丨景峯醫藥(000908.SZ)公佈,近日,公司子公司海南錦瑞製藥有限公司獲得國家藥品監督管理局核准簽發的化學藥品“伏立康唑片”的《藥品注冊證書》。
審批結論: 根據《中華人民共和國藥品管理法》及有關規定,經審查,本品符合藥品注冊的有關要求,批准註冊,發給藥品註冊證書。質量標準、説明書、標籤及生產工藝照所附執行。藥品生產企業應當符合藥品生產質量管理規範要求方可生產銷售。
請關注以下藥學問題:(1)請結合原料藥生產工藝對潛在致突變雜質氯乙酰氯及其轉化物氯乙酸、氯乙酸酯等進行分析研究並積累數據,參考ICH M7制定合理的控制策略,於兩年內以補充申請的形式提交相關研究資料。(2)本品用原料藥工藝路線較短,請加強供應商審計,以保證供應商能始終穩定地生產出符合要求的原料藥。
伏立康唑為新一代三唑類抗真菌藥物,其作用機制是抑制真菌中由細胞色素P450介導的14-甾醇去甲基化,從而抑制麥角甾醇的生物合成,與其它三唑類抗真菌藥物相比抗菌譜拓寬,抗菌活性增強。
本品對念珠菌屬(包括耐氟康唑的克柔念珠菌,光滑念珠菌和白色念珠菌耐藥株)具有抗菌作用,對所有檢測的麴黴屬真菌有殺菌作用。適用於治療侵襲性麴黴病、非中性粒細胞減少患者中的念珠菌血症、氟康唑耐藥的念珠菌引起的嚴重侵襲性感染(包括克柔念珠菌)等。此外,伏立康唑在體外對其他致病性真菌亦有殺菌作用,包括對現在抗真菌藥敏感性較低的菌屬,例如足放線病菌屬和鐮刀菌屬。本品為口服片劑,其生物利用度高,可用於胃腸道功能正常的患者,對腎功能不全不宜靜脈製劑的患者尤為適用。
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