格隆汇4月27日丨昂利康(002940.SZ)公布，近日，浙江昂利康制药股份有限公司收到国家药品监督管理局签发的注射用ALK-N0011《药物临床试验批准通知书》。
临床前研究结果显示，注射用ALK-N001在HT1080(人纤维肉瘤)及CT26(小鼠结肠癌)模型中，ALK-N001均能剂量依赖性抑制肿瘤生长。与DXD治疗比较，ALK-N001等摩尔剂量或低摩尔剂量的抑瘤效果更强，其最终肿瘤抑制率T/C(%)均优于DXD治疗组，此外，ALK-N001与PD-1抗体联合试验，具有协同作用。在大鼠、犬4周重复给药毒性试验中，ALK-N001的安全性良好，在大鼠中最大耐受剂量(MTD)为12mg/kg，犬中最高非严重毒性剂量(HSNTD)为2.5mg/kg，综合考虑药效、药代、安全性数据，计算药物安全窗，ALK-N001安全窗约为10.6-15.3倍。综合临床前研究结果，ALK-N001显示了良好的药效和安全性，是一款极具创新性与开发潜力的小分子偶联抗肿瘤药物，有望为晚期实体瘤患者提供新的治疗选择。
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