奧賽康(002755.SZ):子公司新藥ASKC202片獲批臨牀試驗
格隆匯2月15日丨奧賽康(002755.SZ)公佈,公司的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ASKC202片《藥物臨牀試驗批准通知書》,由子公司申報的ASKC202片已獲臨牀試驗批准。
ASKC202片是具有自主知識產權的1類新藥,是一種強效、高選擇性的口服小分子c-MET抑制劑。多種癌症中出現MET基因改變或蛋白異常表達現象,包括非小細胞肺癌、胃癌、肝細胞癌等。MET通路異常激活引起MET基因擴增、蛋白過表達或基因突變,除了作為原發驅動致癌因素,MET過量激活與其它靶向療法的耐藥機制相關,其中最主要的為EGFR抑制劑的旁路耐藥,5%-22%EGFR抑制劑耐藥非小細胞肺癌患者出現MET基因擴增。
靶向c-MET已成為腫瘤治療領域的研發熱點,國際上批准了兩款高選擇性MET抑制劑,分別是默克公司開發的tepotinib和諾華公司開發的capmatinib,目前國內僅有和記黃埔的沃利替尼片於2021年6月獲批上市。子公司於2021年12月2日提交臨牀試驗註冊申請獲得CDE受理,近日通過審評獲得《藥物臨牀試驗批准通知書》。
ASKC202作為靶向c-MET的小分子抑制劑,已在一系列臨牀前腫瘤模型中證明了其活性,有望為c-MET通路異常腫瘤患者提供新的治療選擇。目前上市的高選擇性MET抑制劑均用於治療MET14外顯子跳躍突變的非小細胞肺癌,尚沒有藥物獲批用於EGFRTKI耐藥c-MET擴增型腫瘤患者。
ASKC202項目將與公司三代EGFR抑制劑ASK120067聯合,用於一代EGFR抑制劑耐藥的T790M陰性患者,以及用於三代EGFR抑制劑耐藥的患者,進一步拓展非小細胞肺癌的目標人羣,使更多的患者獲益。ASKC202的開發將有利於進一步完善公司抗腫瘤產品線,提高公司的競爭力和持續盈利能力,對公司的戰略佈局起到積極作用。
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