Nanjing-based Huadong Medicine Co., Ltd (SHE: 000963) has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its biosimilar version of Novo Nordisk’s (NYSE: NVO) weight loss drug semaglutide, which is marketed under the names Ozempic and Wegovy. Huadong Medicine’s biosimilar will be evaluated for weight management purposes.
Semaglutide, a GLP-1 agonist, has been approved in China for the treatment of type 2 diabetes and weight reduction in 2021 and 2024, respectively. Notably, Huadong Med’s biosimilar is the first of its kind to be approved in the country. The company has partnered with PEG-BIO Biopharm Co., Ltd since October 2020 to co-develop and commercialize this product globally. The drug has already been cleared for a clinical study in diabetes in China in June 2022, with a Phase III study expected to deliver major endpoint data in Q4 2024.- Flcube.com