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永太科技(002326.SZ):子公司多潘立酮片通過仿製藥一致性評價
格隆匯 11-01 22:33

格隆匯11月1日丨永太科技(002326.SZ)公佈,公司子公司佛山手心製藥有限公司於近日收到國家藥品監督管理局核准簽發的化學藥品多潘立酮片的《藥品補充申請批准通知書》,該產品通過仿製藥質量和療效一致性評價

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。

公司多潘立酮片通過一致性評價,有利於提升該藥品的市場競爭力,同時為公司後續產品開展仿製藥一致性評價工作積累了經驗。由於醫藥產品的行業特點,藥品的生產、銷售受到市場環境、行業政策、供求關係等因影響,具有一定的不確定性。

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