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翰宇藥業(300199.SZ):依替巴肽注射液獲得美國FDA註冊批件
格隆匯 03-23 20:17

格隆匯3月23日丨翰宇藥業(300199.SZ)公佈,公司近日收到美國食品藥品監督管理局(FDA)簽發的依替巴肽注射液上市許可批准。

依替巴肽又名愛啡肽,適應症為抗凝血(抗血小板聚集),用於急性冠狀動脈綜合徵患者,包括接受藥物治療的患者和進行經皮冠狀動脈介入術(PCI)的患者,是2011年美國心臟學院基金會(ACCF)、美國心臟協會(AHA)、(美國)心血管造影和介入學會(SCAI)經皮冠脈介入(PCI)治療指南推薦用藥,屬於第三代抗血小板藥物,冠心病抗血小板治療的一線藥物。

依替巴肽注射液ANDA申請是公司提交的第一個規範市場製劑上市申請,對公司戰略意義較大,此次依替巴肽注射液獲得美國FDA的上市許可標誌着公司具備了在美國市場銷售該藥品的資格,未來將進一步擴大公司國際市場業務,有利於提升公司的國際品牌影響力和國際市場競爭力,為公司國際市場拓展帶來積極影響,公司將積極推動該藥品在海外市場的銷售。

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