智通财经APP讯，兆科眼科-B(06622)发布公告，美国食品药品监督管理局(FDA)已向公司拥有专利配方、用于治疗儿童视网膜母细胞瘤(RB，一种罕见的儿童眼癌)的美法仑授出孤儿药资格认证(Orphan Drug Designation，ODD)。
取得ODD为在美国提交新药临床试验申请(新药试验申请)建立清晰的监管路径。再者，如果美法仑获成功研发并获批准，公司将在新药上市申请批准后享有七年美国市场独家权利。此项完善保护涵盖上市许可持有人(marketing authorization holder，MAH)地位及数据独家权利，尤其重要的是，即使配方有所创新，FDA亦不得批准任何其他以美法仑为基础的RB适应症产品。
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