魯抗醫藥(600789.SH):蒙脱石散通過仿製藥一致性評價
格隆匯1月13日丨魯抗醫藥(600789.SH)公佈,近日,公司控股子公司山東魯抗醫藥集團賽特有限責任公司(以下簡稱“賽特公司”)收到國家藥品監督管理局頒發的關於蒙脱石散的《藥品補充申請批件》,該藥品通過仿製藥質量和療效一致性評價。
蒙脱石散是天然硅鋁酸鹽黏土礦石,最初由IPSENPHARMA(益普生藥業)研發,於1980年3月在法國上市。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。目前蒙脱石散在國內主要用於成人及兒童急、慢性腹瀉;食道、胃、十二指腸疾病引起的相關疼痛症狀的輔助治療,是國內感染性腹瀉臨牀指南的推薦用藥。
2019年1-9月份,蒙脱石散國內醫療機構終端和零售終端銷售額約為7億元人民幣,賽特公司該產品的銷售收入為217.31萬元。該藥品開展一致性評價工作以來,賽特公司累計研發投入約為230萬元人民幣(未經審計)。
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