信達生物(01801.HK):FGFR1/2/3抑制劑針對膽管癌的新適應症上市申請獲NMPA受理
格隆匯7月9日丨信達生物(01801.HK)發佈公吿,國家藥品監督管理局(“NMPA”)已經正式受理成纖維細胞生長因子受體(“FGFR”)1/2/3抑制劑(pemigatinib片)用於既往至少接受過一種系統性治療,且經檢測確認存在有FGFR2融合或重排的晚期、轉移性或不可手術切除的膽管癌成人患者治療的新適應症上市申請。Pemigatinib(一種酪氨酸激酶抑制劑)由Incyte和信達生物共同開發,信達生物負責中國大陸、中國香港、中國澳門和中國台灣的商業化。2021年6月21日,pemigatinib在台灣市場獲批相同適應症。
膽管癌是第二常見的原發於肝臟的惡性腫瘤。乙肝病毒及其他肝臟寄生蟲的感染導致其在亞洲地區發病率較高。大部分膽管癌患者首次診斷時腫瘤即處於無法切除或者轉移的狀態,治療手段有限。Pemigatinib在既往經過至少一線標準治療失敗的存在FGFR2融合的晚期膽管癌患者的臨牀試驗數據結果展示出了pemigatinib 令人滿意的安全性及療效。監於難治性人羣的治療挑戰性增加,以及目前研究中觀察到的數據頗具前景,公司相信伴FGFR2融合或重排的患者可能會從靶向治療中獲益。
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