Good News | HYBIO Pharmaceutical Completes Official NMPA Registration of Semaglutide API

Recently, a public disclosure by China’s National Medical Products Administration (NMPA) indicated that Hybio Pharmaceutical (Wuhan) Co., Ltd. has completed the official registration of its semaglutide active pharmaceutical ingredient (API) (Registration No.: Y20250001408, last updated on January 16, 2026). According to the disclosure, the product is a domestically manufactured API and has completed registration filings for multiple packaging specifications. This milestone represents another key step in HYBIO Pharmaceutical’s semaglutide value chain, providing a solid foundation for the company and its partners to advance subsequent formulation development and industrial-scale production.

Semaglutide, a globally important GLP-1 (glucagon-like peptide-1) receptor agonist, has well-established clinical value in indications such as Type 2 Diabetes and weight management, with strong and sustained market demand worldwide. As the global market continues to expand, supply chain constraints have become increasingly prominent, creating meaningful opportunities for high-quality API manufacturers.

The completion of the NMPA public registration for semaglutide API marks a significant milestone in HYBIO Pharmaceutical’s “API plus formulation” dual-engine strategy. Leveraging its core expertise in peptide synthesis, the company has successfully addressed key challenges associated with long-chain peptide manufacturing, including purity control and process consistency. In parallel, Process Optimization has delivered cost efficiencies that, combined with successful completion of high-standard regulatory review, are expected to enhance the product’s competitiveness and support broader market adoption.

About Hybio Pharmaceutical

Hybio Pharmaceutical is an A-share listed national high-tech enterprise focused on the research, development, manufacturing, and commercialization of innovative medicines. With more than 20 years of expertise in Peptide Drugs, the company has built a comprehensive formulation pipeline covering major global peptide targets, including but not limited to innovative GLP-1R/GIPR/GCGR triple receptor agonists, Retatrutide, Tirzepatide, Semaglutide, and Liraglutide, as well as other globally significant peptide ANDA products.

Hybio Pharmaceutical has been granted nearly 500 patents worldwide and was the first company globally to obtain U.S. FDA approval for a Liraglutide ANDA daily formulation. Its products have successfully entered regulated markets in Europe and the United States.