近年来,国内药企正加速出海,其以 “临床价值 + 全球合规” 为核心,已深度融入全球主流市场。据悉,2026 年初,国产药在 FDA 获批与受理就已十分密集。如1月12日,润生药业自主研发的核心产品“沙美特罗替卡松吸入粉雾剂”(药品申请号:ANDA 214464),正式获得美国食品药品监督管理局(FDA)批准上市。据悉,该产品已于2025年在国内市场申报上市,目前处于国家药监局及国家药品审评中心...
Source Link近年来,国内药企正加速出海,其以 “临床价值 + 全球合规” 为核心,已深度融入全球主流市场。据悉,2026 年初,国产药在 FDA 获批与受理就已十分密集。如1月12日,润生药业自主研发的核心产品“沙美特罗替卡松吸入粉雾剂”(药品申请号:ANDA 214464),正式获得美国食品药品监督管理局(FDA)批准上市。据悉,该产品已于2025年在国内市场申报上市,目前处于国家药监局及国家药品审评中心...
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