Lee’s Pharm Wins FDA Clearance for U.S. ADASUVE Manufacturing Shift

Lee’s Pharmaceutical Holdings Limited ( (HK:0950) ) has provided an announcement.

Lee’s Pharmaceutical Holdings Limited has secured U.S. Food and Drug Administration approval for a supplemental new drug application relating to ADASUVE (loxapine) Inhalation Powder, authorising the move of the drug’s commercial manufacturing facility from Mountain View to Fremont, California. The approval, obtained via its wholly owned U.S. subsidiary Nova Pneuma Incorporated following the acquisition of the relevant assets in December 2025, clears the Fremont site for commercial production of ADASUVE in the United States and marks completion of the regulatory requirements tied to Lee’s Pharm’s first U.S.-based pharmaceutical facility acquisition. This milestone strengthens the group’s push into innovative drug delivery technologies based on the Staccato platform, underpins its global expansion strategy, and reinforces its emphasis on regulatory compliance and pharmaceutical quality, with implications for an enhanced U.S. footprint and broader therapeutic applications over time.

The most recent analyst rating on (HK:0950) stock is a Hold with a HK$1.50 price target. To see the full list of analyst forecasts on Lee’s Pharmaceutical Holdings Limited stock, see the HK:0950 Stock Forecast page.

More about Lee’s Pharmaceutical Holdings Limited

Lee’s Pharmaceutical Holdings Limited is a research-driven, market-oriented biopharmaceutical company with more than 30 years’ experience in China’s pharmaceutical industry. Fully integrated across drug development, clinical development, regulatory affairs, manufacturing, sales and marketing, it partners with around 30 international companies and markets over 25 proprietary, generic and licensed-in products across Mainland China, Hong Kong, Macau and Taiwan. The group focuses on cardiovascular health, women’s health, paediatrics, rare diseases, oncology, dermatology and obstetrics, and has recently expanded into U.S.-based assets to broaden its innovative drug delivery portfolio built on the Staccato platform as part of its global expansion strategy.

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