Recently, Tonghua Dongbao Pharmaceutical Co., Ltd. ("Dongbao Pharm" or the "Company") officially received a Good Manufacturing Practice (GMP) certificate for its human insulin injection product series, which was issued by the National Pharmaceutical Regulatory Agency (NPRA) under the Ministry of Health of Malaysia, a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). This marks another significant milestone in the regulatory compliance process for the Company's human insulin products in Southeast Asia and represents a key step forward in the global expansion of its insulin products.

PIC/S GMP certification is a high-standard quality management system certification recognized across the global pharmaceutical industry. With its stringent end-to-end review standards and broad international recognition, it serves as a key regulatory credential for pharmaceutical products entering major international markets. As one of the core pharmaceutical markets in Southeast Asia and a full PIC/S member, Malaysia maintains a pharmaceutical regulatory system aligned with international standards. The successful certification not only reflects the Malaysian authorities' strong recognition of the Company's end-to-end capabilities, including manufacturing processes, quality controls, and compliant operations, but also demonstrates that the quality management system for its human insulin products has reached internationally advanced standards.

The Company has focused on diabetes treatment for many years and has always regarded quality as fundamental to business growth. It has established a high-standard quality control system covering the full product lifecycle, from R&D and manufacturing to inspection and sales. Following the approval of its products in Indonesia and Myanmar, the GMP certificate from Malaysia marks another key milestone in Southeast Asia. This creates strong synergies with the Company's existing market footprint, further strengthens its pharmaceutical market presence in the region, and provides valuable regulatory experience for future market entry in additional Southeast Asian countries.

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. As the prevalence of diabetes continues to rise across Southeast Asia, patients are facing an increasingly urgent need for high-quality, highly accessible insulin products. This GMP certification lays an important foundation for the Company's human insulin products to enter the Malaysian market in the future and is expected to provide local patients with a wider range of treatment options.

In the future, the Company will keep improving its global quality compliance system and advance the market entry of products such as insulin and GLP-1 in more global markets. It will remain firmly committed to its global expansion strategy. By further advancing its international strategy, it aims to provide diabetes patients worldwide with a broader range of high-quality and more accessible treatment options. At the same time, it will leverage the steady expansion and high-quality development of its overseas business to make the business an important driver of long-term growth.