港股异动 | 兆科眼科-B(06622)盘中涨超9% 兆科眼科美法仑获得美国FDA孤儿药资格认证

智通财经
Aug 04

智通财经APP获悉,兆科眼科-B(06622)盘中涨超9%,截至发稿,涨5.59%,报3.02港元,成交额1243.26万港元。

消息面上,兆科眼科近日公告,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(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。

值得注意的是,据兆科眼科官微消息,7月15日,公司宣布最近与法国领先医药企业FAREVA达成战略合作。兆科眼科最近与总部位于法国的全球医药用品、化妆品及家用品委托制造商FAREVA签署了谅解备忘录。根据该备忘录,兆科眼科将成为FAREVA客户在中国寻求药品生产的值得信任的推荐合作伙伴。

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