Tonghua Dongbao Pharmaceutical Co., Ltd. (the "Company" or "Tonghua Dongbao") recently received a drug registration certificate for its insulin aspart injection, issued by the Indonesian Food and Drug Supervisory Agency (BPOM).

Since the beginning of this year, the Company has obtained approvals in Uzbekistan, Nicaragua, Myanmar, Indonesia, and other markets for its human insulin injection and insulin analog injection. Its international drug registration efforts have been expanded and accelerated, with multiple approvals achieved across regions. Geographically, the Company has established a presence at several key nodes along the Belt and Road in Central Asia, Central America, and Southeast Asia. In terms of product portfolio, the Company has moved beyond an export model focused solely on human insulin drug substances and is building an overseas product system combining drug substances and drug products, laying the groundwork to replicate market access experience in more emerging markets.

Indonesia is an important country along the Belt and Road and the largest economy in Southeast Asia, with a total population of 281 million in 2024, ranking fourth globally. According to the 11th edition of the International Diabetes Federation (IDF) Global Diabetes Atlas (2024), the number of adults with diabetes aged 20-79 in Indonesia rose to 20.4264 million in 2024, with a prevalence rate of 11.0% among adults in the same age group. There is a significant gap in diabetes diagnosis and treatment locally, as undiagnosed diabetes patients account for as high as 73.2% of the total diabetic population, and the average annual expenditure per patient related to diabetes is 308.2 US dollars. The Company's insulin aspart 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.

The approval of insulin aspart injection in Indonesia marks an important milestone for the Company's insulin analog products in Southeast Asia. It is another breakthrough following approval for marketing in Myanmar, demonstrating that the Company's global expansion is accelerating steadily. Looking ahead, the Company will continue advancing registration applications for products including human insulin, insulin glargine, and insulin aspart in more emerging markets along the Belt and Road, expanding the regional coverage of its insulin products. In regulated markets, the Company will advance the U.S. BLA review process for insulin aspart, accelerate BLA filings for insulin glargine and insulin lispro, and, in parallel, prepare for European registration filings for insulin analogs, striving to enter the U.S. and European markets as soon as possible.

As the Company continues to execute its internationalization strategy, it will leverage its large-scale manufacturing advantages to provide global patients with endocrine diseases with medicines that are safe, effective, and affordable. The goal is to further expand room for overseas sales growth, supplying the rest of the world with medicines made in China.