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基石藥業-B(02616.HK):普拉替尼用於治療RET融合非小細胞肺癌和RET變異甲狀腺癌新藥上市申請在中國台灣獲受理
格隆匯 02-17 08:05

格隆匯2月17日丨基石藥業-B(02616.HK)發佈公吿,選擇性RET抑制劑普拉替尼用於治療轉染重排 (“RET”)基因融合陽性的局部晚期或轉移性非小細胞肺癌(“NSCLC”)、RET突變的晚期或轉移性甲狀腺髓樣癌(“MTC”)以及放射性碘難治(如放射性碘適用)的RET融合陽性的晚期或轉移性甲狀腺癌(“TC”)的新藥上市申請已獲得中國台灣衞生福利部食品藥物管理署(“TFDA”)受理。

根據披露,普拉替尼是一種強效、選擇性 RET 抑制劑,由基石藥業合作伙伴 Blueprint Medicines Corporation (納斯達克股份代號:BPMC)開發。基石藥業與Blueprint Medicines達成了獨家合作和許可協議,獲得普拉替尼在大中華地區,包括中國大陸、中國香港、中國澳門和中國台灣的獨家開發和商業化權利。

基石藥業首席醫學官楊建新博士表示:“我們高興的看到繼去年泰時維?(阿伐替尼片)獲批用於攜帶不可切除或轉移性PDGFRAD842V突變的胃腸道間質瘤患者後,又一款重磅精準藥物普拉替尼成功在中國台灣遞交NSCLC和TC的上市申請。在全球I/II期ARROW臨牀研究中,普拉替尼在RET融合陽性的局部晚期或轉移性NSCLC和RET突變的晚期或轉移性MTC患者中,表現出優異且持久的療效以及良好的耐受性。我們期待普拉替尼能夠早日在中國台灣獲批上市,惠及更多患者。

此次普拉替尼在中國台灣的新藥上市申請獲受理是基於一項全球I/II期ARROW臨牀研究,該研究旨在評估普拉替尼在RET融合陽性的NSCLC、RET突變MTC以及其它攜帶RET變異的晚期實體瘤患者中的安全性、耐受性和有效性。 

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