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華東醫藥(000963.SZ):多潘立酮片國內前三家通過一致性評價
格隆匯 06-08 17:20

格隆匯6月8日丨華東醫藥(000963.SZ)宣佈,近日,公司全資子公司西安博華收到國家藥品監督管理局批准簽發的《藥品補充申請批件》,批件號:2020B03205,西安博華生產的多潘立酮片(10mg)通過仿製藥一致性評價,公司為該品種國內第三家通過一致性評價的企業。

多潘立酮是胃腸促動力藥,直接作用於胃腸壁,可增加胃腸道的蠕動和張力,促進胃排空,增加胃竇和十二指腸運動,協調幽門的收縮,同時也能增強食道的蠕動和食道下端括約肌的張力,抑制噁心、嘔吐。多潘立酮片是比利時Janssen(楊森)公司於1978年研發的一種作用較強的多巴胺受體拮抗劑,被廣泛用於治療噁心和嘔吐。

1980年,Janssen生產的多潘立酮片獲得法國授權,在法國上市。1989年,比利時Janssen在華合資企業西安楊森製藥有限公司生產的多潘立酮片在中國獲批上市,規格為10mg,商品名為嗎丁啉,是本品的原研地產化產品。

根據米內網中國城市公立醫院化學藥終端競爭格局數據庫,2019年多潘立酮片國內城市公立醫院終端銷售額約為人民幣6億元,西安博華多潘立酮片2019年銷售額為1086萬元,同比增長率達36.43%,2019年的市場份額為1.8%。

截至目前本品在仿製藥一致性評價上的研發投入約為1100萬元。

公司表示,公司多潘立酮片通過一致性評價,加強了公司消化道領域產品線,有望通過擴大在醫院端、零售端及基層用藥端的市場份額,提升該產品的市場競爭力。公司也將進一步增強該產品的整體成本優勢、技術優勢,為廣大患者提供優質優價的用藥選擇。

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