甘李药业股份有限公司关于甘精胰岛素注射液获得欧盟委员会上市许可的公告

Core Viewpoint - Gan & Lee Pharmaceuticals has received marketing authorization from the European Commission for its insulin glargine injection (brand name: Ondibta?), which is intended for the treatment of diabetes in adults, adolescents, and children aged 2 years and older [1][3]. Group 1: Product Information - The insulin glargine injection is a long-acting insulin that requires subcutaneous injection once daily, providing a stable blood concentration and effective glucose control for 24 hours [1][4]. - The product is available in a pre-filled pen format with a concentration of 100 units/ml in a 3ml vial [4]. Group 2: Market Context - According to the International Diabetes Federation, there are approximately 588.7 million diabetes patients aged 20-79 globally, with 65.6 million in Europe, representing 11.1% of the global patient population [2]. - The total medical expenditure due to diabetes is estimated at $193 billion globally, with an average annual expenditure of $2,951 per patient [2]. - Sanofi is currently the main supplier of insulin glargine in Europe, with projected global sales of €2.855 billion (approximately $2.989 billion) for 2024, including €819 million (approximately $857 million) in Europe [2]. Group 3: Financial Investment - As of September 30, 2025, Gan & Lee Pharmaceuticals has invested a total of ¥936 million in research and development for the insulin glargine project [3].