Core Viewpoint - Tonghua Dongbao Pharmaceutical Co., Ltd. has received a drug registration certificate for its Aspart Insulin Injection from the Ministry of Public Health and Social Welfare of the Dominican Republic, indicating a significant opportunity to expand its market presence in the region [1][3]. Group 1: Product Registration Details - Product Name: Aspart Insulin Injection [1] - Dosage Form: Injection [1] - Specification: 3ml:300IU (100 units per ml) in a pre-filled pen [1] - Indication: Diabetes [1] - Registration Number: RM2025-1863 [1] - Manufacturer: Tonghua Dongbao Pharmaceutical Co., Ltd. [1] Group 2: Market Context - The Dominican Republic is the largest economy in the Caribbean and one of the fastest-growing in Latin America, with a population of approximately 10.76 million as of 2024 [2]. - The demand for medical services in the Dominican Republic has been increasing, with an estimated 1.2037 million diabetes patients aged 20-79 in 2024, representing a prevalence rate of 16.6% [2]. - A significant portion of diabetes patients (42.8%) remain undiagnosed, highlighting a substantial unmet medical need [2]. - The average annual expenditure per diabetes patient is approximately $1,353.9 [2]. Group 3: Impact on the Company - The approval of Aspart Insulin Injection allows Tonghua Dongbao to sell the product in the Dominican Republic, enhancing its international product line and brand image [3]. - This development is expected to accelerate the company's expansion into emerging markets and improve its competitiveness in the international market [3].
通化东宝药业股份有限公司 关于门冬胰岛素注射液获得境外药品注册证书的公告