再鼎醫藥-SB(09688.HK)國家藥監局批准擎樂®用於治療晚期胃腸道間質瘤新藥上市申請
格隆匯 3 月 31日丨再鼎醫藥-SB(09688.HK)公吿，中華人民共和國國家藥品監督管理局("國家藥監局")已批准擎樂®(瑞派替尼)("擎樂®")的新藥上市申請("NDA")，該藥物為由Deciphera Pharmaceuticals,Inc.(一家於納斯達克上市的公司(納斯達克：DCPH)，"Deciphera")開發的一種開關調控酪氨酸激酶抑制劑，用於治療既往接受過包括伊馬替尼在內的三種或以上激酶抑制劑治療的晚期胃腸道間質瘤("GIST")成人患者。本公司與Deciphera於2019年6月訂立獨家授權協議，據此，公司取得Deciphera若干專利及專有技術的獨家授權，於大中華地區開發及商業化包括擎樂?在內的產品，用於防治、預防、治療、治癒或緩解任何人類疾病或病症的領域。
擎樂®為一種酪氨酸激酶開關控制抑制劑，通過使用雙重作用機理來調節激酶開關盒及活化環，從而廣泛抑制KIT原致癌基因受體酪氨酸激酶("KIT")及血小板衍化生長因子受體A("PDGFRα")激酶信號通路。擎樂®抑制GIST中涉及的第9、11、13、14、17及18外顯子中的原發性及繼發性KIT突變，以及第17外顯子中的原發性D816V突變。擎樂®亦抑制GIST的一個亞羣中涉及的第12、14及18外顯子中的原發性PDGFRα突變，包括第18外顯子的D842V突變。擎樂®首次於2020年5月獲美國食品藥品監督管理局批准，其後獲加拿大衞生部及香港衞生署批准，用於治療既往接受過伊馬替尼、舒尼替尼和瑞弋非尼治療的晚期GIST成人患者。
擎樂®亦已獲澳大利亞藥品管理局批准用於治療既往接受過包括伊馬替尼在內的三種或以上激酶抑制劑治療的晚期GIST成人患者。基於INVICTUS關鍵性3期研究，擎樂®在無進展生存期和總生存期方面均表現出臨牀獲益，並在治療晚期GIST患者方面展現出良好的安全性。
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