China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that a clinical trial filing for its biosimilar version of Novo Nordisk’s Ozempic (semaglutide), submitted by subsidiaries Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd and Chongqing Peg-Bio Biopharma Co., Ltd, has been approved by the National Medical Products Administration (NMPA).
Drug Profile
Originally developed by Danish firm Novo Nordisk, semaglutide is a long-acting glucagon-like peptide-1 (GLP-1) analog. It reduces blood glucose by promoting insulin secretion from pancreatic islet cells and offers additional benefits in weight loss and improved cardiovascular performance. The drug is marketed in 52 countries and was first approved in China in April 2021 for the treatment of obesity and related conditions, as well as type 2 diabetes. It generated close to USD 6 billion in sales in 2021.
Partnership and Development
Zhongmei Huadong and Peg-Bio entered into a partnership for the development of semaglutide in October 2020. Under the agreement, Peg-Bio is responsible for pre-clinical studies, while Zhongmei Huadong handles global development, regulatory filings, and commercialization. Meanwhile, other companies such as United Laboratories, Livzon Group, Jiuyuan Gene, and Qilu Pharma are also seeking clinical trial approvals in China for their own generic versions. Additionally, Sihuan Pharma, Tonghua Dongbao, and Sinopep-Allsino Bio are developing similar products.-Fineline Info & Tech
