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Global Expansion | Tonghua Dongbao's Mixed Isophane Protamine Human Insulin Injection Approved for Marketing in Nicaragua
Date：2025-05-14
Author：東寶
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Tonghua Dongbao Pharmaceutical Co., Ltd. ("the Company") recently received marketing approval for its Mixed Isophane Protamine Human Insulin Injection from the regulatory authorities of Nicaragua (ANRS). This approval marks the Company's official entry into the Nicaragua market for human insulin injections and is expected to further expand its overseas sales potential.
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 July 2023, the total population was about 6.844 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 11th edition of the International Diabetes Federation (IDF) Global Diabetes Atlas (2024), there were about 377 thousand diabetes patients aged 20 to 79 in Nicaragua, with a prevalence rate of 8.7%. Among these, undiagnosed cases accounted for a high proportion, reaching 44.6%. The average annual expenditure per patient related to diabetes is 587 US dollars.
To seize overseas opportunities, the Company has leveraged its competitive strengths and implemented a differentiated expansion strategy, tailored to the market size, growth potential, healthcare system, medication needs, and treatment habits of each target country or region. Its human insulin products are primarily positioned for emerging markets and developing countries in the Belt and Road Initiative, with customized sales strategies based on local conditions.
In April this year, the Company's liraglutide injection obtained a GMP certificate from Colombia. The approval for marketing of the Company's human insulin injection in Nicaragua marks another breakthrough in the Company's market access in the Americas. This will help enrich the Company's international product portfolio and enhance its brand image, while further expanding and deepening its international business. These successful practices also provide a replicable pathway for subsequent overseas market access filings. They are expected to accelerate the Company's entry into other countries in the Americas, support its expansion in emerging markets and Belt and Road markets, and further strengthen its competitiveness in international markets.
