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億帆醫藥(002019.SZ):子公司收到氯法拉濱注射液境內註冊上市許可申請受理通知書
格隆匯 08-02 21:46

格隆匯8月2日丨億帆醫藥(002019.SZ)公佈,公司全資子公司合肥億帆生物製藥有限公司(“億帆製藥”)於2021年8月2日收到國家藥品監督管理局簽發的氯法拉濱注射液境內註冊上市許可申請《受理通知書》。

氯法拉濱注射液為細胞毒類抗腫瘤藥,主要用於兒童難治性或複發性急性淋巴細胞性白血病,是目前唯一可以特異性用於兒童白血病的化療藥,治療白血病總體反應率高,安全且良好耐受,無非預知的不良反應,既可以靜脈給藥,也可以口服,屬於臨牀急需品種。

截止報吿披露日,中國尚無原研及仿製藥產品上市,有3家企業正在進行臨牀實驗,國內尚無按照一致性評價標準申報的廠家,因此公司有望成為首家視同通過一致性評價的企業。

根據IQVIA數據庫顯示,2020年氯法拉濱注射液全球市場規模約2.02億元,全球銷量約1.57萬支。

截止報吿披露日,公司在該項目上研發投入3460.96萬元。

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