基石藥業(02616.HK)：pralsetinib註冊研究達到預期結果，計劃近期向NMPA遞交新藥上市申請
格隆匯 7 月 9日丨基石藥業－Ｂ(02616.HK)發佈公告，公司公佈了 RET 抑制劑 pralsetinib 在全球 I/II 期 ARROW 關鍵性試驗中中國患者的研究結果。研究資料顯示，pralsetinib 在 RET 融合陽性的非小細胞肺癌(“NSCLC”)中國患者中具有優越和持久的臨牀抗腫瘤活性且耐受性良好。 pralsetinib 是由基石藥業的戰略合作伙伴 Blueprint Medicines Corporation (納斯達克股份代號：BPMC)開發的一款強效、高選擇性針對致癌性 RET 變異(包括可預見的耐藥突變)的在研藥物。此次研究的整體資料顯示，pralsetinib 在 RET 融合陽性的 NSCLC 中國患者中的療效結果和安全性與先前 ARROW 研究中全球患者人羣報告的資料結果一致。
基石藥業首席醫學官楊建新博士表示：“我們很高興看到 pralsetinib 在經含鉑化療的 RET 融合陽性的 NSCLC 中國患者的關鍵性臨牀研究達到預期的結果。目前，國內尚無選擇性 RET 抑制劑獲批，基石藥業計劃於近期向中國國家藥品監督管理局(“NMPA”)遞交 pralsetinib 治療該適應症的新藥上市申請。同時，我們將繼續全力推進 pralsetinib 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，早日滿足這部分中國癌症患者亟待解決的臨牀需求。”
基石藥業計劃在未來的學術會議上分享該試驗的具體資料。有關重點消息包括：主要療效資料顯示，pralsetinib 在經含鉑化療的 RET 融合陽性的 NSCLC 的中國患者中顯示出了優越和持久的抗腫瘤活性；pralsetinib 在中國患者人羣中的安全性及耐受性良好；基石藥業計劃於近期向 NMPA 藥品審評中心(“CDE”)遞交 pralsetinib 治療經含鉑化療的 RET 融合陽性的非小細胞肺癌的新藥上市申請。
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