2025年3月3日,国家药监局网站公布当日药品通知件送达信息,乐普生物(02157.HK)的维贝柯妥塔单抗(MRG003)名列其中。这意味着,该款药物的上市申请暂未成功获批。 公司于3月4日早间回应称,为补充提交相关资料,公司主动撤回前次MRG003的NDA(新药上市申请)。公司将于今日重新提交MRG003的NDA。公告指出,因补充提交相关资料,MRG003的上市获批进程可能延迟。不过二级市场...
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