Recently, the insulin aspart injection, developed by Tonghua Dongbao Pharmaceutical Co., Ltd. ("Dongbao Pharm" or "the Company") and Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. ("Kingfriend"), has been officially approved for marketing by the U.S. Food and Drug Administration (FDA).

This represents a major milestone in the Company's internationalization, marking the official recognition of its R&D capabilities, manufacturing processes, and quality management system by one of the world's most stringent regulatory authorities and laying a solid foundation for making the Company's products available to people with diabetes worldwide.

Strong Capabilities Built Over Time Open the Door to the Highly Regulated Market

This approval is the result of more than three decades of dedicated work in the field of diabetes treatment. As a pioneer and leading company in China's insulin industry, Dongbao Pharm has built an R&D and manufacturing system that meets the highest international standards, steadily laying a solid foundation for its global expansion.

Notably, it took only about four months for insulin aspart to go from the U.S. FDA on-site inspection to final approval. The efficient, smooth review process fully demonstrates the close alignment of the Company's manufacturing quality system with international standards.

The United States has the world's largest pharmaceutical market and is also one of the largest markets for diabetes medication. According to the International Diabetes Federation (IDF) Diabetes Atlas 11th edition, the number of people with diabetes in the United States continues to grow. In 2024, approximately 38.54 million adults aged 20–79 had diabetes, with a prevalence rate of 15.7%. Total diabetes-related healthcare expenditure reached USD 404.5 billion, with an average expenditure of USD 10,497 per person, one of the highest globally. The total number of people with diabetes is projected to rise to 43 million by 2050. In addition, according to the American Diabetes Association (ADA) 2024 annual report, approximately 7.7 million people in the United States rely on injectable insulin, indicating significant market potential. According to Novo Nordisk's 2025 annual report, sales of its insulin aspart in the United States amounted to DKK 7.166 billion, equivalent to approximately USD 1.126 billion, while global sales amounted to DKK 15.765 billion, equivalent to approximately USD 2.477 billion.

Registration Progress in the United States and Europe Puts Global Expansion on a Fast Track to Results

In recent years, the Company has accelerated the implementation of its international strategy, expanding its presence across multiple global markets.

In Europe and the United States, the Company's insulin aspart injection has been approved for marketing in the United States, while its insulin aspart manufacturing site recently obtained an EU GMP certificate. Registration of its insulin glargine and insulin lispro in Europe and the United States is also progressing in an orderly manner. In emerging markets, the Company's insulin injection products have been approved for marketing in countries such as Indonesia, Myanmar, the Dominican Republic, Uzbekistan, and Nicaragua. Liraglutide injection has also been approved for marketing in Peru and Nicaragua. Overseas sales revenue continues to grow rapidly.

From emerging markets in Southeast Asia and Latin America to high-end markets in Europe and the United States, and from insulin drug substances to drug products and GLP-1 products, the Company is building a broader product portfolio and a more comprehensive presence across global markets. The Company's global expansion has moved from strategic planning into an accelerated phase of realizing results, becoming a key growth driver alongside its domestic business.