智通财经APP讯，兆科眼科-B(06622)发布公告，中国国家药品监督管理局已受理公司核心产品之一、用于治疗儿童近视加深的NVK002(低剂量阿托品0.01%)的简化新药申请。
此项简化新药申请乃以其在中国的第III期临床试验结果为基础。于2023年8月，公司在中国完成为期一年的第III期临床试验最后一名患者的最后一次访视。该项试验涉及16间中心，入组526名患者。小型CHAMP成功达到主要疗效指标，对比安慰剂表现出统计学及临床意义方面的差异，并显示出强大的安全性及疗效以及很高的患者耐受性。
公司同时进行一项并行、为期两年的第III期临床试验，并于2024年8月完成最后一名患者的最后一次访视。该项试验涉及18间中心，入组777名患者。China CHAMP的顶线结果显示NVK002具有显著的安全性及疗效，足证该药物可作为儿童近视加深的潜在治疗方案。
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