Boan Biotech Out-licenses Its Dulaglutide Injection in the U.S.

Yantai, June 4, 2026 -- Boan Biotech announced that it has entered into a licensing agreement for the United States rights of BA5101 (Dulaglutide Injection). Under the agreement, the partner will commercialize BA5101 in the U.S. market, including Biologics License Applications(BLA) and sales; and Boan Biotech will receive an upfront payment, milestone payments, and sales-based commissions.

Boan Biotech independently developed BA5101 following the company’s global R&D strategy. It was approved for marketing in China in August 2025, making it the world’s first and only approved biosimilar to Trulicity®. The company has secured regulatory clearance for BA5101 to initiate clinical trials in the U.S, with plans to have it commercialized across multiple markets around the world.

Dulaglutide is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist administered once a week. It improves pancreatic β-cell function and stably and effectively lowers blood glucose and HbA1c levels. In addition to glycemic control, dulaglutide also offers other clinical benefits, such as a reduced risk of major adverse cardiovascular events, weight loss, renal protection, a low incidence of hypoglycemia, and mild gastrointestinal adverse reactions.^1,2 Its once-weekly dosing frequency also helps reduce patient inconvenience and improve treatment adherence. In the U.S., Trulicity is indicated: 1) As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. 2) To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.² 

The development of BA5101 strictly followed the regulatory guidelines for biosimilars in China, the U.S., and the EU. Its overall similarity to Trulicity has been established by evidence from a series of analytical, non-clinical, human pharmacokinetics, and clinical studies. The two products were shown to be highly similar in quality, efficacy, safety, and immunogenicity, with no clinically meaningful differences. BA5101 is positioned to enhance patient access to dulaglutide as a premium, cost-effective therapeutic alternative for individuals living with type 2 diabetes worldwide. 

Concurrently, the burden of diabetes on global public health continues to escalate. Data released by International Diabetes Federation indicate that diabetes affected approximately 38.5 million U.S. adults and 589 million individuals globally aged 20 to 79. By 2050, these patient populations are projected to reach 43 million in the U.S. and 853 million worldwide³.  According to public data, Trulicity generated approximately USD 4.276 billion of global sales in 2025, with the U.S. market contributing USD 2.914 billion⁴. 

Boan Biotech and its partner will pool resources to capture this substantial market opportunity together, while jointly improving the accessibility of dulaglutide. The partner possesses a fully integrated U.S. infrastructure spanning R&D, quality management, regulatory affairs, and commercial operations. Notably, it maintains one of the most comprehensive injectable portfolios in the U.S. market. Its local commercial platform is actively expanding its offerings through partnerships and acquisitions. It has also established a robust pipeline of biosimilar candidates. And its manufacturing facility for biologics has already cleared on-site U.S. Food and Drug Administration (FDA) inspections.

Boan Biotech is among the few fully-integrated biopharmaceutical companies in China with end-to-end R&D, manufacturing and commercial capabilities. It has successfully launched five products to date. To support its global commercialization goals, the company has established a comprehensive quality management system compliant with standards in China, the U.S., Europe, and Japan, ensuring the provision of high-quality biologics for international markets. Boan Biotech is actively building external partnerships with leading global players to drive its vision of becoming a leading biopharmaceutical company in the world.

References:
1. Hertel C Cerstein, Helen M Colhoun, Gilles R Dagenais, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial [J]. Lancet. https://doi.org/10.1016/S0140-6736(19)31149-3
2. Label of TRULICITY (dulaglutide) injection
3. International Diabetes Federation. https://diabetesatlas.org/.Accessed on June 3, 2026
4. Eli Lilly and Company 2025 Annual Report. https://investor.lilly.com/static-files/70c644f5-d894-471a-a4c5-6464848ca393