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基石藥業-B(02616.HK):中國國家藥監局批准泰吉華(阿伐替尼片)新藥上市申請
格隆匯 03-31 18:24

格隆匯3月31日丨基石藥業-B(02616.HK)發佈公吿,中國國家藥品監督管理局批准泰吉華(阿伐替尼片)新藥上市申請,用於治療血小板衍生生長因子受體A(PDGFRA)外顯子18突變(包括PDGFRA D842V突變)不可切除或轉移性胃腸道間質瘤(GIST)成人患者。泰吉華由基石藥業合作伙伴Blueprint Medicines公司開發,該藥是中國首個用於治療PDGFRA外顯子18突變型GIST患者的精準治療藥物,其通過專門的設計來針對該疾病的驅動基因。

基石藥業董事長、執行董事兼首席執行官江寧軍博士表示:泰吉華是基石藥業同月內獲批上市的第二款產品,該產品是針對PDGFRA外顯子18突變型GIST的同類首創藥物。此次獲批是對基石藥業整個團隊努力的充分肯定。公司感謝所有參與泰吉華臨牀研究的患者和研究者的付出和貢獻,同時,也非常感謝國家藥監局為泰吉華獲批而開展的優先審評審批工作,旨在致力於共同解決中國癌症患者迫切的尚未被滿足的醫療需求。隨着公司兩款精準治療藥物的相繼獲批上市,公司將繼續不遺餘力的為全球癌症患者帶來更多同類首創和同類最優的腫瘤治療藥物。

北京大學腫瘤醫院副院長沈琳教授表示:一直以來,PDGFRA外顯子18突變的GIST患者缺乏治療藥物。泰吉華在PDGFRA外顯子18突變的中國晚期GIST患者中表現出了非常好的抗腫瘤活性,且安全性和耐受性良好。泰吉華在國內獲批,無疑將為這部分患者帶來巨大的生存獲益。

據悉,泰吉華是一種激酶抑制劑,已獲中國國家藥品監督管理局批准,用於治療攜帶PDGFRA外顯子18突變(包括PDGFRA D842V突變)的不可切除性或轉移性GIST成人患者。在美國,美國食品藥品監督管理局批准其以商品名AYVAKITTM上市銷售,用於治療攜帶PDGFRA外顯子18突變(包括PDGFRA D842V突變)的不可切除性或轉移性GIST成人患者。在歐盟,歐洲藥品管理局批准其以商品名AYVAKYT上市銷售,用於治療攜帶PDGFRA D842V突變無法切除或轉移性胃腸道間質瘤成人患者阿伐替尼在中國、美國、歐盟還未獲批用於其他適應症,或者其它地區的醫療監管機構均還未對阿伐替尼的任何適應症做出批准決定。

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