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石四藥集團(02005.HK):治療腫瘤口服片劑新藥申請獲國家藥品監督管理局受理
格隆匯 01-15 17:39

格隆匯1月15日丨石四藥集團(02005.HK)發佈公告,NP-01片(25mg及50mg)的新藥申請已獲中國國家藥品監督管理局藥品審評中心受理(受理號:CXHL2000022及CXHL2000023)。該產品為用於治療腫瘤的口服片劑。

公告表示,NP-01為集團與國內研究機構共同開發,具有自主知識產權的全新小分子化合物,其專利已經在中國、美國和歐洲獲得授權,屬於化學藥品1類新藥。研究表明,NP-01在胃癌、肝癌、肺癌、前列腺癌等多種腫瘤動物模型中表現出優異的抗腫瘤活性,具有良好的藥代動力學特徵,兼具良好的安全性和耐受性,特別是在胃癌PDX模型(人源腫瘤異種移植模型)中顯示優於已經上市的抗胃癌小分子靶向藥物的抑瘤活性,並且有望拓展至肝癌、肺癌、前列線癌等其他腫瘤,全球尚無同靶點藥物獲批上市。

NP-01為適度選擇性的KDR/MET/Axl多靶點激酶抑制劑,可以實現對腫瘤新生血管的控制,調控腫瘤微環境,激活自身免疫系統,提高腫瘤治療效果,通過對KDR-MET-Axl的協同作用,有望解決原發和獲得性耐藥的問題。NP-01也優化激酶選擇性,可以實現安全性與有效性的平衡。  

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