【艾德生物:收到医疗器械变更注册文件】金融界2月20日消息,厦门艾德生物医药科技股份有限公司于近日收到国家药品监督管理局颁发的《医疗器械变更注册文件》,已完成“PD-L1抗体试剂(免疫组织化学法)”产品原注册证相关事项的变更。变更内容为预期用途增加相关表述。公司PD-L1抗体试剂已获批用于非小细胞肺癌、胃癌及胃食管交界处腺癌的伴随诊断。此次变更显著增强公司综合竞争力与市场拓展能力,产品实际销售情况取决于未来市场推广效果,尚无法预测对公司未来业绩的影响。

金融界
20 Feb
金融界2月20日消息,厦门艾德生物医药科技股份有限公司于近日收到国家药品监督管理局颁发的《医疗器械变更注册文件》,已完成“PD-L1抗体试剂(免疫组织化学法)”产品原注册证相关事项的变更。变更内容为预期用途增加相关表述。公司PD-L1抗体试剂已获批用于非小细胞肺癌、胃癌及胃食管交界处腺癌的伴随诊断。此次变更显著增强公司综合竞争力与市场拓展能力,产品实际销售情况取决于未来市场推广效果,尚无法预测对公司未来业绩的影响。

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