美諾華(603538.SH):用於治療原發性高血壓的氯沙坦鉀片獲批上市
格隆匯11月8日丨美諾華(603538.SH)公佈,公司與歐洲知名藥企 KRKA D.D.,NOVO MESTO (“KRKA”)共同投資成立的寧波科爾康美諾華藥業有限公司(“科爾康美諾華”)於近日收到國家藥品監督管理局核准簽發的“氯沙坦鉀片”《藥品註冊證書》,該藥品用於治療原發性高血壓。
該藥品的獲批主體科爾康美諾華是公司與戰略客户 KRKA 本着資源共享、優勢互補、互利互惠、長遠戰略合作的原則,為深入開展製劑領域合作而在國內共同設立的合資公司,公司持股佔比 40%。以合資公司科爾康美諾華為主體並作為藥品上市許可持有人(MAH),以公司全資子公司美諾華天康為生產廠商,雙方協力將 KRKA 在歐洲已上市產品進行國內轉報,推動其製劑產品在國內市場的開拓。上述合作在實現公司原料藥和製劑 CMO 業務持續穩定增長的同時,將拓寬豐富公司的製劑管線,加速提升自身生產、銷售與研發能力,進一步推進公司製劑一體化轉型。
此次氯沙坦鉀片獲得國家藥監局《藥品註冊證書》,標誌着科爾康美諾華獲得了該款藥品在國內市場生產、銷售的資格,並且該款藥品生產所需的原料藥由公司子公司浙江美諾華藥物化學有限公司配套生產,能進一步豐富公司產品結構、提升公司市場競爭力,對公司業績將產生積極影響。
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