基石藥業-B(02616.HK)：普吉華®(普拉替尼膠囊)在RET突變甲狀腺髓樣癌中國患者註冊研究達預期
格隆匯6月28日丨基石藥業-B(02616.HK)宣佈療轉染重排(“RET”)抑制劑普吉華®在全球I/II期ARROW關鍵性試驗的中國患者註冊研究結果。研究數據顯示，普吉華®(普拉替尼膠囊)在晚期或轉移性RET突變甲狀腺髓樣癌(“MTC”)中國患者中，顯示出了優越和持久的抗腫瘤活性，與先前報導的ARROW全球人羣中一致，整體安全性與全球人羣相似。這是繼今年3月在中國獲批用於治療既往接受過含鉑化療的RET融合陽性的局部晚期或轉移性非小細胞肺癌(“NSCLC”)患者後，普吉華®在甲狀腺癌領域取得的又一重磅進展。普吉華是一種強效、選擇性RET抑制劑，由基石藥業合作夥伴Blueprint Medicines(NASDAQ:BPMC)開發。
ARROW研究主要研究者、天津市人民醫院院長高明教授表示：“近年來，甲狀腺癌發病率持續上升，但臨牀上用於RET突變MTC的治療方案極爲有限。針對RET變異的精準靶向藥物在甲狀腺癌適應證還均未在國內獲批。我們很高興看到普吉華®在RET突變MTC中國患者的關鍵性臨牀研究達到預期的結果，期待普吉華®能夠滿足更多甲狀腺癌患者亟待解決的臨牀需求。”
基石藥業首席醫學官楊建新博士表示：“我們很高興看到普吉華®針對RET突變的中國甲狀腺癌患者取得了優異的療效，並且安全性良好。基石藥業已於今年4月向NMPA滾動遞交了普吉華®用於晚期或轉移性RET突變MTC和晚期或轉移性RET融合陽性甲狀腺癌的擴展適應症申請，並被NMPA納入優先審評。我們期待普吉華®用於甲狀腺癌的適應證早日獲批，惠及中國甲狀腺癌患者。”
基石藥業計劃在近期召開的國際學術會議上公佈該註冊研究的具體數據。此前，普吉華®針對晚期或轉移性RET突變MTC的擬定適應證已被NMPA藥品審評中心納入突破性治療品種。此前，普吉華®針對晚期或轉移性RET突變MTC和晚期或轉移性RET融合陽性甲狀腺癌的擴展適應症申請已滾動遞交獲NMPA受理並被納入優先審評。
普吉華®是一種強效、選擇性RET抑制劑，由基石藥業合作夥伴Blueprint Medicines開發。基石藥業與Blueprint Medicines達成了獨家合作和授權合約，獲得普吉華®在大中華地區，包括中國大陸、中國香港、中國澳門和中國臺灣的獨家開發和商業化權利。
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