海思科(002653.SZ):複方降壓藥培哚普利吲達帕胺片獲批上市
格隆匯7月26日丨海思科(002653.SZ)公佈,公司旗下全資孫公司海思科製藥(眉山)有限公司於近日收到國家藥監局下發的關於培哚普利吲達帕胺片的《藥品註冊證書》。培哚普利吲達帕胺片適應症:用於成人原發性高血壓的治療。該藥品適用於單獨服用培哚普利不能完全控制血壓的患者。
經查詢,培哚普利吲達帕胺片(Perindopril and Indapamide Tablets)由法國LES LABORATOIRES SERVIER開發,最早於1997年在法國上市,於2003年在西班牙上市,上市規格為培哚普利叔丁4mg,吲達帕胺1.25mg,主要用於原發性高血壓,適用於單獨服用培哚普利不能完全控制血壓的患者。
原研廠家LES LABORATOIRES SERVIER地產化的培哚普利吲達帕胺片於2005年獲批准由施維雅(天津)製藥有限公司生產,商品名為:百普樂®。其規格為培哚普利叔丁胺2mg,吲達帕胺0.625mg(國藥準字H20051755)和培哚普利叔丁胺4mg,吲達帕胺1.25mg(國藥準字H20051756)。其適應症為原發性高血壓,適用於單獨服用培哚普利不能完全控制血壓的患者。
公司獲批的培哚普利吲達帕胺片,規格為培哚普利叔丁胺4mg,吲達帕胺1.25mg,其劑型、規格、適應症與原研百普樂®一致。目前國內只有原研地生產廠家施維雅(天津)製藥有限公司上市,尚無仿製藥上市,公司是視同通過一致性評價上市的首家仿製藥企業。
據米內網全國放大數據,該產品2020年城市公立醫院及縣級公立醫院銷售額約為1.90億元。據IMS數據,2020年培哚普利吲達帕胺複方全球銷售額約5.16億美元。
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