60 Degrees Pharmaceuticals向FDA提交澳大利亚栗子提取物新膳食成分申请

美股速递

Mar 18

**FDA新膳食成分申请提交** 60 Degrees Pharmaceuticals, Inc.（简称60度制药）已向美国食品药品监督管理局（FDA）提交新膳食成分（NDIN）申请，涉及澳大利亚栗子提取物。该申请标志着公司正式启动该成分在美国膳食补充剂市场的合规准入流程。

**监管审批流程与市场准入** 根据FDA规定，新膳食成分需通过NDIN程序进行安全性评估后方可上市。此次提交的澳大利亚栗子提取物若获批准，将可用于膳食补充剂产品。目前全球植物提取物市场保持增长态势，消费者对天然健康产品的需求持续上升，特别是在免疫支持和抗衰老领域具有市场潜力。

**公司战略布局与行业背景** 60度制药此前主要专注于抗疟疾药物研发，此次向膳食成分领域拓展显示公司多元化战略布局。植物提取物作为膳食补充剂核心原料，其市场规模近年来稳步扩大。随着健康消费意识提升，具有天然来源和科学背书的新成分往往能获得更高市场关注度。

**后续步骤与市场影响** FDA通常需在75天内对NDIN申请完成初审。若申请通过，60度制药将获得该成分在美国市场的独家销售窗口期。此举可能为公司开辟新的收入来源，并提升在健康产品领域的品牌影响力。投资者将关注审批进展及后续商业化计划披露。

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