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]
李氏大药厂：FDA批准《ADASUVE 》的补充新药上市申请