信達生物(01801.HK):FDA批准新藥Pemazyre之上市申請
信達生物(01801.HK)公布,美國食品藥品監督管理局(FDA)已批准Incyte公司的Pemazyre(pemigatinib)的新藥上市申請。Pemazyre是成纖維細胞生長因子受體1/2/3激(酉每)抑制劑,適用於既往接受過治療、採用FDA批准方法檢測的具有FGFR2基因融合或其他重排且不可手術切除的局部晚期或轉移性膽管癌成人患者。Pemazyre是第一個也是唯一一個被FDA批准用於此適應症的治療藥物。
另公司附屬Innovent HK和Incyte就Incyte的3個臨床階段候選藥物達成了戰略合作,當中包括Pemazyre。Innovent HK擁有在內地、香港、澳門和台灣地區對Pemazyre及其他兩個候選藥物進行開發和商業化的權利。
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