China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced that the National Medical Products Administration (NMPA) has accepted its clinical trial filing for semaglutide, a Category 2.2 product. Category 2.2 products in China are new formulations of known drugs that aim to offer a demonstrable clinical benefit over the originator product.
Semaglutide’s Origins and Applications
Semaglutide, originated by Novo Nordisk, is marketed under the brand name Ozempic for type 2 diabetes and weight-loss indications, as well as Rybelsus for the oral form of the drug. It is a GLP-1 receptor agonist used to reduce weight in specific patients, control blood sugar levels in type 2 diabetes patients, and lower the risk of major cardiovascular events such as heart attacks or strokes. To date, no generic versions of semaglutide have been launched globally.
Market Performance and Domestic Competition
In 2022, Ozempic, Rybelsus, and Wegovy generated global sales of USD 8.6 billion, USD 1.6 billion, and USD 890 million, respectively. Meanwhile, domestic Chinese firms Livzon Pharma, Huadong Medicine, and Sinopep-Allsino Bio are also developing generic versions of the molecule, indicating a competitive landscape for semaglutide in the Chinese market.-Fineline Info & Tech
