睿昂基因(688217.SH):就白血病基因檢測產品WT1 mRNA測定試劑盒與大塚製藥簽署獨家經銷協議
格隆匯7月1日丨睿昂基因(688217.SH)公佈,近日,公司與大塚製藥株式會社(“大塚製藥”)簽署了《獨家經銷協議》,大塚製藥授予公司白血病基因檢測產品WT1 mRNA測定試劑盒(實時定量PCR法)在中國的獨家銷售權。
WT1 mRNA測定試劑盒(實時定量PCR法),為獲國家藥品監督管理局批准的進口醫療器械產品,用於定量檢測從人體外周血白細胞或骨髓有核細胞提取出的RNA中的腎母細胞瘤-1基因(WT1) mRNA的表達水平。該產品在日本獲批用於骨髓異常增生綜合徵(“MDS”)的輔助診斷、病情進展輔助監測指標,以及急性髓系白血病和急性淋巴細胞白血病的微小殘留病灶監測。該產品2020年在日本的銷售量達到15萬人份,是被使用最多的白血病基因檢測產品。
在國內,該產品已獲國家藥品監督管理局批准,用於MDS的輔助診斷,以及作為MDS病程發展輔助監測指標。
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