基石藥業-B(02616.HK):普拉替尼RET融合非小細胞肺癌適應症上市申請已獲NMPA受理並納入優先審評
格隆匯 9 月 7日丨基石藥業-B(02616.HK)發佈公告,國家藥品監督管理局(“NMPA”)已受理基石藥業普拉替尼膠囊(“普拉替尼”)的新藥上市申請(“NDA”)並納入優先審評,用於治療經含鉑化療的RET融合陽性的非小細胞肺癌(“NSCLC”)患者。普拉替尼是由基石藥業戰略合作伙伴Blueprint Medicines Corporation(納斯達克股份代號:BPMC)(“Blueprint Medicines”)開發的一款口服、強效和高選擇性靶向致癌性RET變異(包括可預見的耐藥突變)的在研藥物。在基石藥業正在開展的註冊橋接試驗中,普拉替尼在經含鉑化療的RET融合陽性的NSCLC中國患者中顯示出了優越和持久的抗腫瘤活性,並且安全性及耐受性良好,這一結果與先前ARROW研究中全球患者人羣報告的資料結果一致。
ARROW研究主要研究者,廣東省人民醫院吳一龍教授表示:“在肺癌精準治療領域,針對RET靶點的研發是繼EGFR、ALK、ROS1和NTRK等靶點後另一個巨大的突破。目前,國內尚無選擇性RET抑制劑獲批。對於RET融合陽性NSCLC患者,國內尚存在巨大未滿足的臨牀治療需求。普拉替尼在全球性試驗以及在中國NSCLC患者中的研究結果令我們對其在國內的上市及其對患者帶來的獲益充滿期待。”
基石藥業董事長兼首席執行官江寧軍博士表示:“我們很高興看到NMPA已受理普拉替尼用於治療經含鉑化療的RET融合陽性NSCLC的適應症上市申請,並將其納入優先審評。這是基石藥業今年在全球遞交的第三個、中國大陸遞交的第二個新藥上市申請,充分表明了基石藥業正在商業化戰略轉型的道路上加速邁進。我們期待普拉替尼早日在國內上市,為中國廣大RET融合陽性NSCLC患者帶來新的治療希望。”
基石藥業首席醫學官楊建新博士表示:“我們很高興看到普拉替尼在臨牀試驗中展現了快速和持久的抗腫瘤活性以及良好的安全性及耐受性。值得一提的是,從我們與Blueprint Medicines Corporation達成合作到普拉替尼在國內成功遞交上市申請僅用了2年時間。我們將繼續全力推進普拉替尼在中國的研發進展,更廣泛地評估該產品在未經含鉑化療的RET融合陽性的NSCLC、甲狀腺髓樣癌和其它實體瘤患者中的療效,早日滿足這部分癌症患者亟待解決的臨牀需求。”
根據基石藥業和Blueprint Medicines簽訂的獨家合作及授權授權合約,基石藥業擁有普拉替尼單藥或聯合治療在大中華地區(包括中國大陸、中國香港特別行政區、中國澳門特別行政區和中國台灣)的臨牀開發與商業化權利。在大中華地區外,Blueprint Medicines與羅氏和基羅氏集團成員Genentech達成了普拉替尼的全球合作。通過合作,羅氏將獲得普拉替尼在大中華地區和美國以外市場的全球獨家許可,以及在美國和Blueprint Medicines共同開發和商業化普拉替尼的權利。
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