LEE'S PHARM(00950): FDA approves supplemental new drug application for "ADASUVE" to be launched on the market.

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 approval of the supplemental new drug application authorizes the commercial manufacturing facility for ADASUVE to be relocated from Mountain View, California to Fremont, California. The application was 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 relevant assets in December 2025. Following FDA approval, the production facility in Fremont, California has been authorized to commence commercial production of ADASUVE within the U.S. The FDA approval obtained by NPI marks a significant regulatory milestone for the group and signifies the completion of regulatory requirements related to the company's first U.S. pharmaceutical facility acquisition. The Board believes that this approval supports the group's strategic expansion of its innovative drug delivery technology portfolio based on the Staccato platform, which has the potential to be used in a variety of therapeutic indications, aligning with the company's global expansion strategy and commitment to regulatory compliance and drug quality.