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昆藥集團(600422.SH):“KY100001片”臨牀試驗申請獲受理
格隆匯 09-18 16:47

格隆匯 9 月 18日丨昆藥集團(600422.SH)公佈,近日,公司收到國家藥品監督管理局簽發的《受理通知書》,公司申請的KY100001片(受理號:CXHL2000444國和CXHL2000445國,“該新藥”)的藥品臨牀試驗申請已獲得國家藥品監督管理局(“NMPA”)受理。

藥品名稱:KY100001片;受理號:CXHL2000444國和CXHL2000445國;劑型:口服片劑;規格:50mg/片和250mg/片;申請事項:新藥申請;申報階段:臨牀;申請人:昆藥集團股份有限公司;結論:予以受理。

KY100001是由昆藥集團股份有限公司研製的一款針對IDH1基因突變的實體瘤的選擇性抑制劑,適應症為:IDH1基因突變的實體瘤,包括但不限於肝內膽管瘤。

目前已上市的小分子IDH1抑制劑是由Agios製藥開發的Ivosidenib(AG-120),於2018年獲得美國FDA批准,用於治療IDH1突變的複發性或難治性急性髓性細胞白血病(AML)成年患者。2019年又獲美國FDA批准增加適應症,用於診療年齡≥75歲或因合併症無法使用強化誘導化療的新診斷的IDH1突變的AML成年患者。除AML適應症外,Ivosidenib也在進行IDH1基因突變相關的多個瘤種的探索,包括骨髓增生異常綜合徵以及實體瘤(包括膽管癌、膠質瘤、軟骨肉瘤等)。其它正在臨牀的選擇性IDH1抑制劑還有諾華的IDH-305、FORMA公司的Olutasidenib(FT-2102)、拜耳的BAY-1436032以及第一三共的DS-1001。

目前,我國尚沒有自主研發的針對IDH1基因突變的選擇性抑制劑進入臨牀研究。KY100001的靶點選擇性高,臨牀前毒理研究中展現了良好的耐受性、安全性風險可控。根據臨牀方案及長遠規劃,一旦KY100001能夠成功上市,首先獲益的具有IDH1突變的肝內膽管瘤患者,長遠來説,隨着研究的持續推進,其它IDH1突變的腫瘤患者,也可能獲益。

截止2020年8月底,公司對該新藥已投入研發費用約2083萬元。

該新藥臨牀申請獲得受理,對公司近期經營業績不會產生重大影響。公司目前同時擁有多個抗腫瘤領域藥物研發管線,KY100001片的開發與公司在抗腫瘤藥物研發領域的戰略佈局相吻合。如KY100001片在預期市場環境下成功上市,預期可為公司帶來一定的經濟效益,為公司的持續發展帶來新動力。

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