LEE'S PHARM (00950) announced that the supplemental new drug application for ADASUVE® (loxapine inhalation powder, a single-dose, single-use drug-device combination product) was approved by the U.S. Food and Drug Administration (FDA) on December 29, 2025. In accordance with Section 505(b)(2) of the U.S. Federal Food, Drug, and Cosmetic Act, the approved supplemental application authorizes the transfer of the commercial manufacturing facility for ADASUVE® from Mountain View, California, to Fremont, California. This application was originally submitted to the FDA by the previous owner on August 29, 2025, and subsequently, the company's wholly-owned subsidiary, Nova Pneuma Incorporated (NPI), acquired the related assets in December 2025. Following the FDA approval, the manufacturing facility located in Fremont, California, is now authorized to conduct commercial production of ADASUVE® within the United States. NPI's receipt of FDA approval marks the Group's achievement of a key regulatory milestone and signifies the completion of regulatory requirements associated with the company's first acquisition of a pharmaceutical manufacturing facility in the U.S. The Board of Directors believes this approval supports the Group's strategic initiative to expand its portfolio of innovative drug delivery technologies based on the Staccato® platform. This portfolio holds potential for application across various therapeutic indications and aligns with the company's global expansion strategy and its ongoing commitment to regulatory compliance and drug quality.