(Yicai) July 28 -- Chinese pharmaceutical company Tonghua Dongbao Pharmaceutical has received the green light from the US Food and Drug Administration to market its insulin aspart injection in the United States, making it the first China-made rapid-acting insulin to win FDA approval.

The insulin aspart injection, jointly developed by Tonghua Dongbao and Nanjing-based King-Friend Pharmaceutical, received an approval letter for its Biologics License Application, the Jilin province-headquartered company announced yesterday. The approval comes about four months after the product underwent an on-site FDA inspection.

The drug is indicated for improving blood sugar control in adult and pediatric patients with diabetes. The approval gives Tonghua Dongbao access to one of the world's largest diabetes treatment markets.

According to the International Diabetes Federation, there were about 38.5 million adults aged 20 to 79 living with diabetes in the US in 2024, representing a prevalence rate of 15.7 percent. Diabetes-related healthcare spending totaled USD404.5 billion, or nearly USD10,500 per patient, making the US one of the countries with the highest per-capita diabetes-related medical expenditure worldwide. The federation forecasts the number of diabetes patients in the US will increase to 43 million by 2050.

According to Danish insulin giant Novo Nordisk's 2025 annual report, almost half of its global insulin aspart sales came from the US, where revenue reached DKK7.2 billion (USD1.1 billion), compared with DKK15.8 billion (USD2.5 billion) worldwide.

Editor: Emmi Laine