奧賽康(002755.SZ):子公司ASK120067片上市許可申請獲受理
格隆匯11月16日丨奧賽康(002755.SZ)公佈,公司全資子公司江蘇奧賽康藥業有限公司於近日收到國家藥品監督管理局下發的ASK120067片境內生產藥品註冊上市許可申請《受理通知書》。
擬定適應症為:單藥用於既往表皮生長因子受體酪氨酸激酶抑制劑(EGFRTKI)治療中或治療後出現疾病進展,並且經檢測確認存在EGFRT790M突變陽性或原發性T790M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。
ASK120067是由中國科學院上海藥物研究所、中國科學院廣州生物醫藥與健康研究院、江蘇奧賽康藥業有限公司聯合開發的具有自主知識產權、全新分子實體、活性顯著的口服的第三代EGFRTKI,用於治療EGFR突變非小細胞肺癌(NSCLC)。肺癌是中國發病率、死亡率最高的惡性腫瘤,EGFR是NSCLC中最常見的驅動基因,30%~50%的亞裔NSCLC患者存在EGFR基因突變,三代EGFR抑制劑具有廣泛的適用人羣和巨大的市場容量。目前同靶點藥物國際國內均上市的產品為奧希替尼,根據阿斯利康年報,2020年奧希替尼全球銷售43.28億美金,以中國為主的新興市場銷售12.08億美金。
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