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最近受理TAB014(公司核心产品之一，用于治疗湿性老年黄斑部病变(wAMD))的生物制剂许可申请。此为中国首款提交生物制剂许可申请、用于治疗wAMD、基于贝伐单抗的抗体。
此生物制剂许可申请以公司于中国进行的第III期临床试验的成功结果为依据。该第III期临床试验为随机、双盲及非劣效性研究，主要目标为评估接受TAB014治疗的对象群组对比接受Lucentis®治疗的对象群组于第52周的最佳矫正视力的基线值变化。研究涉及约57间中心，入组合共488名患者，由北京协和医院的陈有信教授出任牵头主研究者。
于2025年1月，公司公布TAB014第III期临床试验的积极顶线结果，该项临床试验成功达到所有主要终点及关键次要终点。
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