信達生物(01801.HK):達伯坦®(pemigatinib)正式獲得台灣衞生福利部食品藥物管理署批准
格隆匯6月22日丨信達生物(01801.HK)發佈公吿,達伯坦®(pemigatinib)正式獲得中國台灣衞生福利部食品藥物管理署批准,用於治療成人接受過全身性藥物治療、腫瘤具有成纖維細胞生長因子受體2(“FGFR2”)融合或重排、不可手術切除的局部晚期或轉移性膽管癌。達伯坦® (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地區的商業化)這是是首個在中國台灣地區獲批的治療膽道惡性腫瘤的酪氨酸激酶抑制劑。這是信達生物獲批的第一款小分子藥產品,也是信達生物第五款獲批上市的創新藥。
根據披露,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。大部份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。達伯坦®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達伯坦®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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