取得FDA批准后，位于加州弗里蒙特的生产设施已获授权于美国境内进行《ADASUVE®》的商业化生 产。 格隆汇1月27日丨李氏大药厂(00950.HK)公告，公司董事会欣然宣布，《ADASUVE®》(洛沙平吸入粉 剂，一种单剂量、单次使用的药械组合产品)的补充新药上市申请("补充新药申请")已于2025年12月29日 获美国食品药品监督管理局("FDA")批准。 根据《美国联邦食品、药物及化妆品法》(U.S. Federal Food,Drug, and Cosmetic Act)第505(b)(2)条，获批 补充新药申请授权将《ADASUVE®》的商业生产设施由加州山景城(Mountain View, California)迁往加州 弗里蒙特(Fremont,California)。是项申请由原拥有人于2025年8月29日提交予FDA，其后，公司的全资附 属公司Nova Pneuma Incorporated("NPI")于2025年12月收购有关资产，详情已于日期为2025年12月九日 的公布内披露。 NPI取得FDA批准，标志着集团达成关键监管里程碑，亦代表与公司首项美国制药设施收购相关的监管 要求已经 ...

Core Viewpoint - The company has entered into an asset purchase agreement to acquire assets related to Alexza Pharmaceuticals for a total consideration of $15 million, which aligns with its strategy to expand its innovative drug delivery technology portfolio and global outreach [1][2]. Group 1: Acquisition Details - The buyer, Nova Pneuma Incorporated, a wholly-owned subsidiary of the company, will acquire all assets related to Alexza's business, including properties, equipment, materials, patents, and other intellectual property [1]. - The total purchase price for the assets is set at $15 million [1]. Group 2: Strategic Alignment - The acquisition supports the company's strategy to expand its product portfolio through the Staccato® platform, which has a wide range of therapeutic potential [2]. - The assets acquired are expected to complement the existing product pipeline and create synergies [2]. - The agreement with UCB, a leading biopharmaceutical company in the epilepsy treatment field, marks a significant milestone in the company's global expansion strategy [2].