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科興製藥(688136.SH):與海昶生物合作開發的藥品HC007境內生產藥品註冊上市許可獲受理
格隆匯 01-14 18:59

格隆匯1月14日丨科興製藥(688136.SH)公佈,近日,公司的合作方浙江海昶生物醫藥技術有限公司(“海昶生物”)收到國家藥品監督管理局(“國家藥監局”)核准簽發的《受理通知書》,公司與海昶生物合作開發的藥品HC007境內生產藥品註冊上市許可獲得受理。

此前披露,HC007中國大陸通用名為注射用紫杉醇(白蛋白結合型),是一種廣譜抗腫瘤的復雜注射製劑,用於轉移性乳腺癌等惡性腫瘤治療,具備與新型免疫、靶向治療聯合用藥潛力。2021425日,科興製藥召開第一屆董事會第二十三次會議審議通過《關於與海昶生物簽署藥品合作協議的議案》。根據協議內容,海昶生物授予科興製藥及/或其指定主體HC007項目在除美國以外的全部區域的商業化權益,並且雙方將在雙方約定的生產場所進行HC007技術轉移。科興製藥根據具體合作的研發及商業化、產業化和持證權益轉讓進度向海昶生物支付累計不超過7000萬人民幣的簽約金和里程金,同時按雙方約定的條件及方式向海昶生物支付銷售權利金

上述藥品已完成生物等效性試驗,在獲得國家藥品監督管理局註冊申請受理後將轉入國家藥品監督管理局藥品審評中心進行審評審批,審評審批完成時間、審批結果均具有不確定性待取得國家藥品監督管理局註冊批件後方可進行上市銷售。

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