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Recently, Tonghua Dongbao Pharmaceutical Co., Ltd. ("Dongbao Pharm" or the "Company") received a drug registration certificate (registration No. 06000760426) for liraglutide injection issued by the Nicaraguan National Health Regulation Authority (ANRS). This marks the first marketing approval of the Company's liraglutide injection in Central America, demonstrating the continued deepening of the Company's global registration strategy for GLP-1 products and representing another important achievement in advancing its global expansion strategy.
Located in the central part of Central America, Nicaragua occupies a strategic position linking North America and South America. It is an emerging market along the Belt and Road. Nicaragua is the largest country in Central America, and its population has continued to grow steadily. As of 2025, the total population was about 7.007 million. In recent years, population aging and the growing number of patients with chronic diseases have continued to drive the growth of healthcare demand in Nicaragua. According to the International Diabetes Federation (IDF) Global Diabetes Atlas 11th edition, Nicaragua had approximately 377,000 diabetes patients aged 20–79 in 2024, with a prevalence rate of 8.7%. Among these, undiagnosed cases accounted for 44.6%. Annual diabetes-related expenditure averaged USD 587 per person. There is an urgent local need for high-quality, affordable drugs for diabetes and metabolic diseases.
The registration of the Company's liraglutide injection in Nicaragua marks another important breakthrough in the Central American market following the approval of its isophane protamine human insulin injection in Nicaragua in 2025. This establishes a coordinated presence for the two core product lines, insulin and GLP-1, in the same market, enabling the Company to provide local patients with more comprehensive treatments for metabolic diseases while further enhancing the accessibility and market penetration of its products in Latin America. The successful registration also fully validates the Company's products against international quality standards and its manufacturing compliance capabilities. This further demonstrates the Company's mature model of working with global partners to develop markets, providing valuable experience for the subsequent global expansion of more GLP-1 and innovative metabolic products.
The Company continues to accelerate the global expansion of its GLP-1 products. In April 2025, it received a GMP certificate from Colombia for its liraglutide injection; in November of the same year, the product was approved for marketing in Peru; in February 2026, a GMP certificate from Brazil was obtained for this product. The approval from Nicaragua further enhances the Company's strategic footprint for GLP-1 products across the Americas, and the Company's global expansion continues to accelerate.
Going forward, the Company will continue to uphold its philosophy of "building a global brand through continuous innovation." It will further strengthen its international registration, overseas sales, and quality teams, accelerate the market entry of liraglutide injection and other high-quality products in more countries and regions worldwide, and provide diabetes patients worldwide with safe, effective, and affordable medicines. Through these efforts, the Company will further advance its international strategy.