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昂利康(002940.SZ):創新藥注射用ALK-N001獲得藥物臨牀試驗批准通知書
格隆匯 04-27 21:37

格隆匯4月27日丨昂利康(002940.SZ)公佈,近日,浙江昂利康製藥股份有限公司收到國家藥品監督管理局簽發的注射用ALK-N0011《藥物臨牀試驗批准通知書》。

臨牀前研究結果顯示,注射用ALK-N001在HT1080(人纖維肉瘤)及CT26(小鼠結腸癌)模型中,ALK-N001均能劑量依賴性抑制腫瘤生長。與DXD治療比較,ALK-N001等摩爾劑量或低摩爾劑量的抑瘤效果更強,其最終腫瘤抑制率T/C(%)均優於DXD治療組,此外,ALK-N001與PD-1抗體聯合試驗,具有協同作用。在大鼠、犬4周重複給藥毒性試驗中,ALK-N001的安全性良好,在大鼠中最大耐受劑量(MTD)為12mg/kg,犬中最高非嚴重毒性劑量(HSNTD)為2.5mg/kg,綜合考慮藥效、藥代、安全性數據,計算藥物安全窗,ALK-N001安全窗約為10.6-15.3倍。綜合臨牀前研究結果,ALK-N001顯示了良好的藥效和安全性,是一款極具創新性與開發潛力的小分子偶聯抗腫瘤藥物,有望為晚期實體瘤患者提供新的治療選擇。

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