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]
李氏大药厂(00950)：FDA批准《ADASUVE®》的补充新药上市申请