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方盛製藥(603998.SH):公司藥品蒙脱石散通過仿製藥一致性評價
格隆匯 01-19 18:58

格隆匯1月19日丨方盛製藥(603998.SH)公佈,近日,公司收到國家藥監局頒發的關於蒙脱石散的《藥品補充申請批件通知書》,確認該藥品通過仿製藥質量和療效一致性評價。

蒙脱石散具有層紋狀結構和非均勻性電荷分佈,對消化道內的病毒、病菌及其產生的毒素、氣體等有極強的固定、抑制作用,使其失去致病作用;此外對消化道黏膜還具有很強的覆蓋保護能力,修復、提高黏膜屏障對攻擊因子的防禦功能,具有平衡正常菌羣和局部止痛作用,用於治療成人及兒童急、慢性腹瀉等疾病。

截至本公吿日,公司針對該藥品仿製藥質量和療效一致性評價已投入研發費用約742萬元人民幣(未經審計)。2020年,公司生產的蒙脱石散實現銷售收入為1421.30萬元。

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