Recently, the liraglutide injection, developed by Tonghua Dongbao Pharmaceutical Co., Ltd. ("Tonghua Dongbao" or "the Company") and its partner, Kexing Biopharm Co., Ltd. ("Kexing Biopharm"), has received GMP certification from Colombia's National Food and Drug Surveillance Institute (INVIMA). Backed by Tonghua Dongbao's internationally compliant production quality management system and Kexing Biopharm's expertise in overseas drug registration, this certification lays a solid foundation for the product's future approval in Colombia and market entry across other Latin American countries.

According to the latest data from the International Diabetes Federation (IDF), there were approximately 589 million adults with diabetes worldwide in 2024, a figure expected to rise to 853 million by 2050. Latin America, a region with a high prevalence of diabetes, sees a growing number of adult diabetes patients. Colombia, the third most populous country in Latin America and the fourth-largest pharmaceutical market in the region, is experiencing a steady increase in pharmaceutical spending, with strong demand for chronic disease treatments.

The liraglutide injection, a GLP-1 receptor agonist, has become a first-line therapy for diabetes worldwide due to its benefits in blood glucose control, weight loss, and cardiovascular protection, earning widespread recognition among patients. According to Qianzhan Industrial Research Institute, although GLP-1 receptor agonists account for only 9% of global diabetes medication use, they contribute 38% of the market share. With continued growth in usage and expansion of indications, GLP-1 receptor agonists are expected to have significant market potential. In Colombia, cost-effective biosimilars are favored, and the liraglutide injection developed by the Company and Kexing Biopharm is well positioned to quickly capture market share.

In December 2022, Tonghua Dongbao and Kexing Biopharm, optimistic about the emerging markets, signed an exclusive licensing agreement. Under this agreement, Tonghua Dongbao granted Kexing Biopharm the exclusive rights to commercialize its liraglutide injection product in 17 emerging markets. The two parties, both strong in their respective fields, joined hands to explore the overseas market for liraglutide injection.

Colombia's INVIMA certification standards align with major global regulatory systems. This GMP certificate is the first overseas certification for liraglutide obtained through the collaboration of the two companies, highlighting their strengths in pharmaceutical manufacturing quality management, international registration, and commitment to global markets. In addition to Colombia, the Company's liraglutide injection also underwent an on-site GMP inspection by the Egyptian Ministry of Health and Population in February this year. The inspection is progressing smoothly. In the foreseeable future, the liraglutide injection developed by the Company and Kexing Biopharm is expected to be approved in 17 emerging markets, helping the Company launch its GLP-1 products internationally.

All along, The Company is committed to advancing its global strategy with firm belief, clear planning, and pragmatic action. As more products, such as the liraglutide and insulin series, pass factory inspections and receive approvals in more countries and regions, the Company will speed up its global expansion. In the future, more high-value products will enter international markets, providing safe, effective, and affordable treatments, giving patients more choices, and driving the Company's long-term growth.