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首藥控股(688197.SH):認為SY-5007的競爭格局還是比較樂觀的
格隆匯 06-06 09:47

格隆匯6月6日丨有投資者向首藥控股(688197.SH)提問:高選擇性RET抑制劑後續臨牀進展的計劃,以及如何看待國內的RET抑制劑市場競爭?

首藥控股回覆:今年的ASCO上,我們也就SY-5007的臨牀Ⅰ期的數據發表了壁報:截至2023年2月,Ⅱ期推薦劑量(160mg)下共入組了29名患者(24名非小細胞肺癌患者,4名MTC患者),其中療效可評估患者有28名,其中27名(96.4%)患者腫瘤縮小,ORR和DCR分別為72.4%和89.7%。針對非小細胞肺癌患者,ORR和DCR分別為75.0%和91.7%。

今年1月,CDE基於SY-5007已有的臨牀Ⅰ期安全性和有效性數據,已經同意SY-5007針對RET陽性非小細胞肺癌患者未來採用Ⅱ期單臂臨牀試驗申請附條件上市,公司隨後快速啟動了關鍵性的臨牀Ⅱ期試驗,2月獲得組長單位上海市肺科醫院倫理批件,同月完成首例受試者入組,臨牀進展國內領先。目前我們正在全力推進試驗進度,加速受試者入組。

由於當前國內只有兩款進口同類藥物獲附條件批准上市,價格昂貴,患者可及性低,作為本土創新藥企,基於成本控制和患者長期獲益角度,我們認為SY-5007的競爭格局還是比較樂觀的。

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