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Recently, Tonghua Dongbao Pharmaceutical Co., Ltd. ("Dongbao Pharm" or the "Company") received an approval letter from the Drug Regulatory Authority of Pakistan (DRAP) for its insulin glargine drug substance (DS) product. This enables the Company to officially supply its insulin glargine DS to the Pakistani market, marking another important achievement in Pakistan following human insulin DS.
As a supplier of insulin glargine DS, the Company supported global customers in completing the registration filing and approval for marketing their drug products in Pakistan, through which the Company obtained this approval. This fully demonstrates the Company's competitiveness in global markets for its DS products. With more than two decades of experience in the insulin field, the Company has established a mature and stable system for large-scale DS manufacturing and a full-lifecycle quality control system, enabling it to continuously supply high-quality DS to global partners and jointly improve access to diabetes drugs.
Pakistan is one of the countries with the highest burden of diabetes in the world. According to the International Diabetes Federation (IDF) Diabetes Atlas 11th edition, approximately 34.53 million adults aged 20–79 in Pakistan were living with diabetes in 2024, with a prevalence rate as high as 26.5%, among the highest globally. The number of people with diabetes is projected to rise to 70.2 million by 2050. Based on the current IDF forecasts, Pakistan is expected to surpass the United States by that time to become the country with the third-largest number of people living with diabetes in the world.
At the same time, approximately 9.3 million (about 26.9%) adults with diabetes in Pakistan remain undiagnosed and face the risk of various complications. The large patient population and the significant gap in diagnosis and treatment are driving an urgent and growing need for high-quality, affordable insulin products in the Pakistani market.
Since 2025, Dongbao Pharm has continued to accelerate its global expansion, built a diversified global product portfolio covering human insulin, insulin analogs, and GLP-1, and established a business model combining drug substances and drug products. In terms of market coverage, the Company's insulin product has been approved for marketing in countries such as Indonesia, Myanmar, the Dominican Republic, Uzbekistan, and Nicaragua. Liraglutide has been approved for marketing in Peru and Nicaragua, while the Company has undergone an on-site GMP inspection in Egypt and obtained GMP certificates from Brazil and Colombia. In addition, its insulin aspart product has been approved by the FDA, and an EU GMP certificate has been obtained for its insulin aspart DS. The Company's global business network is now taking shape.
In the future, Dongbao Pharm will keep deepening its international registration strategy, accelerate the market entry of its DS and drug products in more countries and regions, and contribute to the global diabetes treatment system, enabling more patients worldwide to access safe, affordable, and high-quality Dongbao Pharm products.