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三諾生物(300298.SZ):撤回持續葡萄糖監測系統美國FDA註冊申請

格隆匯7月28日丨三諾生物(300298.SZ)公佈,近日,三諾生物傳感股份有限公司收到U.S. Food & Drug Administration(美國食品藥品監督管理局,簡稱“FDA”)的註冊申請撤回確認函,同意公司撤回自主研發的持續葡萄糖監測系統(即公司第一代CGM產品)的註冊申請。

受FDA發補要求、市場變化等因素影響,經審慎研究,結合公司全球CGM管線產品上市策略,公司決定主動撤回本次持續葡萄糖監測系統產品在美國FDA的註冊申請。本次註冊申請撤回後,公司將根據FDA的反饋,繼續完善該系列產品的相關試驗研究工作後,再擇機另行提交新產品的上市註冊申請。

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