基石藥業(02616.HK)普拉替尼膠囊新藥上市申請獲藥監局批准
基石藥業(02616.HK)公布,普拉替尼膠囊「普吉華」的新藥上市申請已獲得中國國家藥品監督管理局批准,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。
該產品由基石藥業合作夥伴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。
董事長兼首席執行官江寧軍表示,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。
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