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中國生物製藥(01177.HK):預防化療引起的噁心嘔吐藥物“注射用福沙匹坦雙葡甲胺”獲美國FDA ANDA批准
格隆匯 03-08 06:09

格隆匯3月8日丨中國生物製藥(01177.HK)發佈公吿,集團研製的預防化療引起的噁心嘔吐藥物“注射用福沙匹坦雙葡甲胺”(商品名:善啟)已獲美國食品藥品監督管理局(“FDA”)批准新藥簡略申請(“ANDA”,即美國仿製藥申請)。這是集團收穫的又一個“三報三批”的品種——該品種在中國、美國、歐洲三個國際主流市場均獲准上市。

注射用福沙匹坦雙葡甲胺是一種神經激肽-1(NK-1)受體拮抗劑,是阿瑞匹坦的前體藥物,臨牀用於預防化療藥引起的噁心和嘔吐。該產品為靜脈注射用粉針劑,療效肯定,安全性高,臨牀使用廣泛。相較於口服阿瑞匹坦,對於一些有與疾病相關噁心無法接受口服給藥的患者,使用注射給藥能夠提供更大的靈活性和便利性。該產品已成為治療腫瘤的處方組合必備的止吐藥。

本次注射用福沙匹坦雙葡甲胺在美獲批是集團實施國際化戰略的又一項成果,再次證明集團進軍海外高端市場的決心和能力。該品種的上市將進一步加快集團拓展腫瘤藥國際市場的進程,為後續一系列高端仿製藥的海外市場推廣做好鋪墊。

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