Group 1 - The company, Lee's Pharmaceutical (00950), announced that its supplemental new drug application for ADASUVE has been approved by the FDA on December 29, 2025 [1] - The approval allows the commercial production facility for ADASUVE to be relocated from Mountain View, California, to Fremont, California [1] - The application was submitted to the FDA on August 29, 2025, by the original owner, and the company's wholly-owned subsidiary, Nova Pneuma Incorporated (NPI), acquired the relevant assets in December 2025 [1] Group 2 - The FDA approval marks a significant regulatory milestone for the group and indicates that the regulatory requirements related to the acquisition of the company's first pharmaceutical facility in the U.S. have been fulfilled [2] - The board believes that this approval supports the group's strategy to expand its innovative drug delivery technology portfolio based on the Staccato platform, which has the potential for application in various therapeutic indications [2] - This development aligns with the company's global expansion strategy and its ongoing commitment to regulatory compliance and drug quality [2]

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 approval of the supplemental new drug application for ADASUVE by the FDA marks a significant regulatory milestone for the company, facilitating the commercial production of the drug in the U.S. [1][2] Group 1: FDA Approval and Production - The FDA approved the supplemental new drug application for ADASUVE on December 29, 2025, allowing the commercial production facility to be relocated from Mountain View, California, to Fremont, California [1] - The application was submitted to the FDA on August 29, 2025, by the original owner, and the company's wholly-owned subsidiary, Nova Pneuma Incorporated, acquired the relevant assets in December 2025 [1] Group 2: Strategic Implications - The FDA approval signifies the completion of regulatory requirements related to the company's first pharmaceutical facility acquisition in the U.S. [2] - The board believes this approval supports the company's strategy to expand its innovative drug delivery technology portfolio based on the Staccato platform, which has the potential for application in various therapeutic indications [2] - This development aligns with the company's global expansion strategy and its commitment to regulatory compliance and drug quality [2]