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Tonghua Dongbao Pharmaceutical Co., Ltd. ("the Company") recently received marketing approval for its Insulin Glargine Injection from the regulatory authorities of Myanmar.

This approval marks the Company's official entry into the Myanmar market for insulin glargine injections, as well as the first approval for marketing its insulin analog injections in an overseas market. It demonstrates the Company's solid capabilities in diabetes treatment and underscores its great potential for growth in international markets.

Located in Southeast Asia, Myanmar is an important participant in the Belt and Road Initiative. As of August 2025, Myanmar's total population was around 51.3 million. In recent years, population aging, urbanization, lifestyle changes, and the rising number of patients with chronic diseases have continued to drive the growth of healthcare demand in Myanmar.

According to the 11th edition of the International Diabetes Federation (IDF) Global Diabetes Atlas (2024), there were about 2.37 million diabetes patients aged 20 to 79 in Myanmar, with a prevalence rate of 6.4%. Among these, undiagnosed cases accounted for a high proportion, reaching 49.7%. The average annual expenditure per patient related to diabetes is 164.1 US dollars. The Company's insulin glargine injection will provide local patients with diabetes with additional treatment options, improve access to treatment, and help meet the country's growing demand for diabetes care.

In recent years, the Company's product portfolio has continued to expand, with multiple insulin analog and GLP-1 products approved for marketing in China. While deepening its presence in the domestic market, the Company has advanced its global development, with its internationalization strategy entering a fast lane, covering multiple products, regions, and models. For human insulin, the Company focuses on emerging markets and countries along the Belt and Road. For insulin analogs, the Company has entered regulated markets such as the United States and the European Union through partnerships, and it is using registration experience in developed markets to accelerate its expansion in emerging markets. For GLP-1 products and Class 1 novel drugs, the Company is actively seeking partnerships and license-out opportunities to further develop overseas markets.

The Company has more than 20 years of export experience. In 2013, it became the first Chinese biopharmaceutical company to obtain EU GMP certification. In 2024, its human insulin passed a GMP audit by the European Medicines Agency (EMA), reflecting continued international recognition of the Company's quality management system. Historically, the Company's exports were mainly insulin drug substances. Over the past two years, however, the Company has achieved breakthroughs in overseas markets for its insulin injection products, continuously securing overseas orders and advancing international registrations. This approval of the Company's insulin glargine injection in Myanmar follows the approvals of its human insulin injection in Uzbekistan and Nicaragua. It is the Company's first overseas approval for an insulin analog injection, demonstrating its capability of supplying both drug substances and drug products for global markets. In addition, the U.S. Biologics License Application (BLA) for insulin aspart has been accepted for review by the U.S. Food and Drug Administration (FDA). The Company will continue to advance BLA filings for insulin glargine and insulin lispro, and will also prepare and submit registration dossiers for insulin analogs in Europe and in emerging markets along the Belt and Road.

From establishing a foothold overseas through human insulin to securing overseas approvals for insulin analogs, the Company's international journey has always been built on quality. Looking ahead, 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; deepen collaboration with global partners; and drive more insulin, GLP-1, and novel drug products into overseas markets. While expanding its international presence and enhancing brand influence, the Company remains committed to providing patients worldwide with safe, effective, and affordable medicines, steadily advancing toward its vision of being an explorer and leader of novel drugs R&D in the field of endocrinology.