Recently, Tonghua Dongbao Pharmaceutical Co., Ltd. ("Dongbao Pharm" or the "Company") officially received a Good Manufacturing Practice (GMP) certificate for its liraglutide injection, jointly developed with its partner, Kexing Biopharm Co., Ltd. ("Kexing Biopharm"). The certificate was issued by the Brazilian Health Regulatory Agency (ANVISA), a Pharmaceutical Inspection Co-operation Scheme (PIC/S) participating authority. This marks a new stage in the regulatory compliance process for the Company's liraglutide injection in a key Latin American market, lays a critical qualification foundation for the product's entry into the Brazilian market, and represents another key milestone in the Company's global expansion of its GLP-1 products.

Recognized across the global pharmaceutical industry as a high-standard pharmaceutical quality management system, GMP certification in PIC/S member countries is known for its rigor, standardization, and strong mutual recognition. As Latin America's largest economy, a core pharmaceutical market, and an important PIC/S member, Brazil has an ANVISA regulatory system that aligns with international markets, with a review process covering the entire pharmaceutical lifecycle, including manufacturing and quality management. Obtaining this GMP certificate demonstrates that the Company's quality management system for its GLP-1 products has reached internationally advanced standards.

According to the International Diabetes Federation (IDF) Diabetes Atlas 11th edition (2024), the number of people with diabetes worldwide continues to rise. 589 million adults aged 20–79 had diabetes in 2024, with a prevalence rate of 11.1%. The total number of people with diabetes is projected to rise to 853 million by 2050. In emerging markets such as Latin America, where the prevalence of diabetes is high and the patient population is growing rapidly, there is an increasingly urgent need for high-quality, highly accessible biopharmaceuticals. The Company's liraglutide injection will provide local patients with a wider range of treatment options.

Since Dongbao Pharm and Kexing Biopharm entered into their global expansion partnership, the two parties have leveraged their respective strengths and worked efficiently together to advance overseas registration and GMP audits for the liraglutide injection. In April 2025, a GMP certificate was obtained for this product from Colombia; in November 2025, the product was approved for marketing in Peru. With this GMP certificate from Brazil, the Company has made breakthroughs across multiple markets in Latin America, further accelerating its global expansion.

Beyond its GLP-1 products, the Company has vigorously advanced its international strategy in recent years and maintained rapid growth in overseas revenue, with several products making significant progress in international registrations. In 2025, its insulin product series has been approved for marketing in five emerging markets, including Indonesia and Uzbekistan. The U.S. Biologics License Application (BLA) for insulin aspart has been accepted by the U.S. Food and Drug Administration (FDA). The EU Marketing Authorization Application (MAA) for insulin aspart has been accepted by the European Medicines Agency (EMA). This marks the continued refinement of the Company's overseas product portfolio and market presence.

Going forward, Dongbao Pharm will continue to uphold its philosophy of "building a global brand through continuous innovation" and further accelerate the implementation of its international strategy. It will deepen cooperation with Kexing Biopharm and expedite the registration and commercialization of liraglutide injection across target overseas markets. At the same time, the Company will continuously strengthen its product R&D and manufacturing capabilities, bring more high-quality treatments for diabetes and endocrine and metabolic diseases to markets worldwide, and provide patients globally with safe, effective, and affordable medicines.