康芝藥業(300086.SZ):蒙脱石散通過仿製藥一致性評價
格隆匯 1 月 12日丨康芝藥業(300086.SZ)公佈,公司近日收到國家藥品監督管理局發的蒙脱石散《藥品補充申請批准通知書》,公司蒙脱石散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,同時適用於成人及兒童急、慢性腹瀉。
目前該藥品市場上有多個生產批件,公司申報的蒙脱石散屬於仿製製劑。
根據國家相關政策規定,同品種藥品通過仿製藥一致性評價的生產企業達到3家以上的,在藥品集中採購等方面不再選用未通過仿製藥一致性評價的品種。因此,公司的蒙脱石散(3g)通過仿製藥一致性評價後,本品市場競爭力將進一步增強,有利於擴大該藥品的市場份額,提升市場競爭力,同時為公司後續產品開展仿製藥一致性評價工作積累了寶貴的經驗。
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