China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced that the US Food and Drug Administration (FDA) has accepted for review the market filing for its semaglutide active pharmaceutical ingredients (APIs). This development marks a significant step for the company as it seeks to enter the global market with its GLP-1 agonist product.
Semaglutide’s Therapeutic Applications and Market Potential
The GLP-1 agonist, semaglutide, is utilized for weight reduction in specific patient populations, management of blood sugar levels in patients with type 2 diabetes, and reduction of the risk of major cardiovascular events such as heart attacks or strokes. Although no generic semaglutide has been approved worldwide, the originator product from Novo Nordisk (NYSE: NVO) is commercially available. Since its approval in April 2021, the drug has seen a steady rise in demand, generating RMB 465 million in hospital sales in 2022.
Competition and Development in China
In China, several pharmaceutical companies including Livzon Pharma (HKG: 1513, SHE: 000513), Huadong Medicine (SHE: 000963), and Sinopep are also developing semaglutide products. The acceptance of Hybio Pharmaceutical’s API filing by the FDA indicates progress in the global regulatory process and highlights the company’s efforts to compete in the international pharmaceutical market with a product that has shown significant clinical benefits and market potential.-Fineline Info & Tech
