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基石藥業(02616.HK)計劃短期內遞交非小細胞肺癌之新藥上市申請
阿思達克 07-09 08:35
基石藥業(02616.HK)公布,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床抗腫瘤活性且耐受性良好。

pralsetinib是由基石藥業的戰略合作夥伴Blueprint Medicines Corporation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 研究中全球患者人群報告的資料結果一致。

公司計劃於近期向NMPA藥品審評中心遞交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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