Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has secured marketing approval from China’s National Medical Products Administration (NMPA) for Adasuve, a loxapine inhaler designed to treat acute agitation in adults with schizophrenia or bipolar I disorder.
This approval is supported by a series of clinical studies conducted across the United States, Europe, and China. Notably, the latest Phase III trial, involving 150 patients in China, successfully met its primary endpoints, demonstrating significant symptom improvement within two hours of administration. This rapid onset of action positions Adasuve as a vital option for managing agitation in these patient populations.
Adasuve is distinguished as the world’s first and only loxapine inhaler specifically approved for this indication. The product is portable, non-invasive, and quick-acting, making it a convenient choice for patients. Initially approved in the U.S. and EU in 2012 and 2013, respectively, Lee’s Pharmaceuticals in-licensed the drug from Alexza Pharmaceuticals Inc. in October 2017, acquiring distribution rights for mainland China, Hong Kong, and Macau.- Flcube.com
