Shenzhen Hybio Pharmaceutical announced that its liraglutide injection has been approved for marketing by the Singapore Health Sciences Authority, with registration number SIN17618P and an issue date of August 20, 2026. The product is an injection in a prefilled pen, with a strength of 6 mg per ml, indicated for glycemic control in adults with type 2 diabetes. In overseas markets, the product received first generic approval from the U.S. FDA in December 2024 and has been marketed and sold, making it the first generic version of this drug approved by the FDA. In the domestic market, the product was approved for marketing in June 2026, becoming the first liraglutide formulation in China approved as a modified new drug under Category 2.2 of chemical drugs and produced through a fully chemical synthesis route, with the same formulation, process, and manufacturing site as the product approved in the United States. The company stated that this approval represents an important step in its internationalization strategy in the Southeast Asian market, helping to expand its business footprint and enrich its overseas pipeline of finished drug products. However, the specific timing and scale of sales are subject to local market conditions, competitive dynamics, exchange rate fluctuations, and other factors, and therefore remain uncertain.
Hybio PharmaceuticalApproval by Singapore HSA for liraglutide injection expands market access, supporting internationalization.
