基石藥業-B(02616.HK)：國家藥監局批准普吉華新藥上市申請
格隆匯3月24日丨基石藥業-B(02616.HK)公佈，中國國家藥品監督管理局批准普吉華（普拉替尼膠囊）新藥上市申請，用於既往接受過含鉑化療的轉染重排(RET)基因融合陽性的局部晚期或轉移性非小細胞肺癌(NSCLC)成人患者的治療。普拉替尼由基石藥業合作伙伴Blueprint Medicines公司開發，是中國第一個獲批上市的選擇性RET抑制劑，同時也是基石藥業首個商業化上市的產品。
ARROW研究是一項旨在評估普拉替尼在RET融合陽性NSCLC、RET突變型甲狀腺髓樣癌和其他RET融合的晚期實體瘤患者中的安全性、耐受性和有效性的全球I/II期臨牀研究。ARROW研究資料顯示，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，總體緩解率(ORR) 為56%，中位緩解持續時間(DOR)未達到，6個月的DOR率為83%。安全性及耐受性良好，未出現與普拉替尼相關的不良事件導致的終止治療或死亡。
基石藥業董事長、執行董事兼首席執行官江寧軍博士表示：“這是一個歷史性的重要時刻，普吉華的獲批印證了基石藥業立足解決患者未滿足的臨牀痛點與訴求的決心，並體現了基石藥業將創新藥物快速推向市場的能力。公司感謝所有為普吉華的臨牀開發做出貢獻的患者和研究者們，以及國家藥監局為普吉華的獲批而開展的優先審評審批工作，同時也非常感謝各級政府給予的支持。公司將繼續全力推進普吉華在中國的研發，更廣泛地評估其在包括一線NSCLC、甲狀腺癌和其它實體瘤患者中的療效，儘快惠及更多患者”。
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，RET靶點的研發是一個巨大的突破。ARROW研究的優異資料結果有力支援了此次普吉華?在中國獲批，並有望改變國內RET融合陽性NSCLC患者的治療標準”。
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