港股異動丨信達生物漲3.6% 美國FDA批准Pemazyre新藥上市申請
格隆匯4月20日丨信達生物(1801.HK)漲3.6%,報34.55港元,總市值464億港元。信達生物今早公佈,美國食品藥品監督管理局(FDA)已批准Incyte Biosciences International Sàrl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(FGFR)1/2/3激酶抑制劑,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。此適應症是根據總體緩解率和緩解持續時間的結果通過加速審批程序被批准的。
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