年度第五個新藥上市申請批准 基石藥業(2616.HK)胃腸道間質瘤精準靶向藥AYVAKIT®在中國香港獲批
12月28日，港股創新藥企基石藥業(2616.HK)宣佈胃腸道間質瘤(GIST)同類首創精準靶向藥AYVAKIT®(阿伐替尼avapritinib)在中國香港地區的新藥上市申請已獲批准，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。該藥物成為中國香港第一個針對攜帶PDGFRA D842V突變GIST患者的精準靶向藥物，也是基石藥業今年在大中華地區繼普吉華®、泰吉華®、泰時維®、擇捷美®之後獲得的第五個新藥上市申請批准。
資料顯示，GIST是發生於胃腸道的肉瘤，肉瘤是發生在骨內或源自結締組織的腫瘤。胃腸道間質瘤起源於胃腸道壁中的細胞，並且最常發生在胃或小腸中。大多數患者的確診年齡在50至80歲之間，通常在胃腸道出血、做手術或醫學影像檢查時發現，極少在腫瘤破裂或胃腸道發生梗阻後確診。原發GIST中，約有5％至6％的病例由PDGFRA D842V突變導致，這種突變是最常見的PDGFRA外顯子18突變。
對於此次獲批，基石藥業董事長兼首席執行官江寧軍博士表示，AYVAKIT®是基石藥業在中國香港獲批的首款產品。“今年AYVAKIT®已先後在中國大陸和台灣地區獲批上市，我們非常欣喜能夠把這一創新療法帶給更多GIST患者。一直以來，基石藥業致力於為全球患者帶來高質量的創新藥物。未來，我們也將不斷努力，加速研發創新藥物，以滿足更多癌症患者的未盡之需。”
據瞭解，2021年上半年，中國國家藥品監督管理局(NMPA)批准其以商品名泰吉華®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。台灣食品藥物管理署批准其以商品名泰時維®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。
此次AYVAKIT®獲得香港衞生署的批准是基於NAVIGATOR研究，該研究是一項開放標籤、劑量遞增/劑量擴展的Ⅰ期研究，評估AYVAKIT®用於不可切除或轉移性GIST患者的安全性和療效。數據顯示，阿伐替尼具備穩健、持久、高效的臨牀獲益，且安全性可控。
全球範圍內，針對AYVAKIT®治療晚期和惰性系統性肥大細胞增生症(SM)患者的臨牀開發正在進行。美國FDA已授予AYVAKIT®突破性療法認定，用於治療晚期SM，包括侵襲性SM的亞型，以及伴有相關血液腫瘤和肥大細胞白血病的SM，以及中度至重度惰性SM。
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