甘李药业股份有限公司 关于甘精胰岛素注射液 及其预填充注射笔获得埃塞俄比亚药品注册批件的公告

Group 1 - The company, Ganli Pharmaceutical Co., Ltd., has received approval from the Ethiopian Food and Drug Authority for the registration of its insulin glargine injection and pre-filled pen, indicating a significant step in its market expansion in Ethiopia [1][2] - The approved drug, BasalinTM, is indicated for diabetes treatment and is available in two forms: injection and pre-filled pen, both with a concentration of 100 units/ml in a 3ml vial [1] - The insulin glargine is a long-acting insulin that requires daily subcutaneous injection, providing a stable blood glucose level for up to 24 hours [1] Group 2 - Ethiopia has a population of approximately 130 million, with a projected diabetes patient population of around 2.3 million among individuals aged 20-79, representing a prevalence rate of 3.6% [2] - The average annual expenditure on diabetes-related healthcare per patient in Ethiopia is estimated at $96.2 [2] - Sanofi is currently the main supplier of insulin glargine in Ethiopia, with global sales of its insulin products projected to reach €2.855 billion (approximately $2.989 billion) in 2024 [2] Group 3 - As of September 30, 2025, the company has invested a total of 936 million RMB in research and development for the insulin glargine project [3]