通化东宝甘精胰岛素注射液 获得缅甸上市许可

Core Viewpoint - Tonghua Dongbao has received approval from the Ministry of Health of the Republic of the Union of Myanmar for the marketing authorization of its product, Glargine Insulin Injection, which is expected to enhance its international market presence and product line [1][3]. Group 1: Product Development and Market Expansion - The company is focused on research and development in the diabetes and endocrine fields, providing comprehensive solutions for patients [1]. - Tonghua Dongbao aims to accelerate the commercialization of multiple products in overseas markets by the first half of 2025, with overseas revenue reaching 110 million yuan, a year-on-year increase of nearly 187% [1][2]. - The company has achieved over 200% year-on-year growth in the sales of insulin analogs in the domestic market during the first half of 2025 [2]. Group 2: Regulatory Approvals and Market Potential - The company’s Aspart Insulin BLA has been accepted by the FDA, and it is progressing with the BLA submissions for Glargine and Lispro Insulin [2]. - The approval of Glargine Insulin is expected to enhance the company's international product line and brand image, while also providing replicable experience for future market access applications [3]. - In Myanmar, the diabetes patient population aged 20-79 is projected to reach 2.3658 million in 2024, with a diabetes prevalence rate of 6.4% among adults [2].