Hong Kong-based United Laboratories International Holdings Ltd (HKG: 3933) announced that the National Medical Products Administration (NMPA) has approved an Investigational New Drug (IND) application for its biosimilar version of Novo Nordisk’s Ozempic (semaglutide). Ozempic is a novel long-acting glucagon-like peptide-1 (GLP-1) analog with a seven-day half-life, used to treat type 2 diabetes and suitable for once-weekly injection. The product was first approved in China in April 2021.
Clinical Trials and Indications
In addition to its use in treating type 2 diabetes, Ozempic is also under clinical investigation for the treatment of obesity, non-alcoholic steatohepatitis (NASH), Alzheimer’s disease, and other conditions. Novo Nordisk reported USD 6 billion in global sales for the drug in 2021.
Competitive Landscape
United Labs joins Huadong Medicine in obtaining clinical trial approval for an Ozempic biosimilar. Other companies with INDs under review include Livzon Pharma, Jiuyuan Gene, and Qilu Pharma. Notably, Sihuan Pharma is also developing an oral version of the product, indicating a growing interest in this therapeutic area.
Future Outlook
With the NMPA’s approval of the IND, United Labs is poised to advance its biosimilar version of Ozempic into clinical trials, aiming to provide an additional treatment option for patients with type 2 diabetes and other related conditions.-Fineline Info & Tech
