兆科眼科获药监局受理NVK002新药申请
财中社1月2日电兆科眼科-B（06622）发布自愿性公告，宣布中国国家药品监督管理局已受理公司核心产品NVK002的简化新药申请。NVK002是一种用于治疗儿童近视加深的低剂量阿托品（0.01%）眼部溶液，申请基于其在中国完成的第III期临床试验结果。该试验于2023年8月结束，涉及16个中心，共526名患者，成功达成主要疗效指标，显示出统计学和临床意义的差异，同时具备强大的安全性和高耐受性。
此外，公司正在进行另一项为期两年的第III期临床试验ChinaCHAMP，预计于2024年8月完成，涉及18个中心，共777名患者。该试验的顶线结果显示NVK002具有显著的安全性及疗效，支持其作为儿童近视加深的潜在治疗方案。董事会认为，NVK002的潜在商业化将有助于满足中国市场对近视治疗的巨大需求。需要注意的是，公司无法保证最终会成功商业化NVK002，股东及潜在投资者在交易时需谨慎。
（文章来源：财中社）
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