Boan Biotech (06955): Dulaglutide injection completed authorization in the United States.

BOAN BIOTECH (06955) announced that the company has reached an authorization agreement with its partner regarding the rights to the US market for the Glucagon-like peptide-1 (GLP-1) receptor agonist injection BA5101. According to the agreement, the partner will be responsible for the commercialization of the product in the US (including market application, sales, etc.), and the company will receive upfront payments, milestone payments, and sales royalties. BA5101, developed based on the company's global development strategy, was independently developed and approved for market in China in August 2025. It is the world's first and currently only approved biosimilar of Trulicity. The product has also been approved for clinical trials in the US and there are plans to commercialize it in multiple countries and regions in the future. Glucagon-like peptide-1 (GLP-1) receptor agonists are a long-acting agent that is administered once weekly. They can improve pancreatic -cell function, stabilize and effectively lower blood sugar levels, and reduce glycosylated hemoglobin (HbA1c) levels. In addition to achieving good blood sugar control, GLP-1 receptor agonists also have multiple clinical benefits, including reducing major cardiovascular events, weight loss, protecting the kidneys, and having a low risk of hypoglycemia and gastrointestinal adverse reactions. The once-weekly dosing frequency can reduce patient inconvenience and help improve treatment compliance. In the US, Trulicity is approved as an adjunct to diet and exercise to improve blood sugar control in adults and children aged 10 and older with type 2 diabetes, as well as to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who have diagnosed cardiovascular disease or multiple cardiovascular risk factors. The development of BA5101 strictly adheres to the biosimilar guidelines of China, the US, and the EU, conducting a series of step-by-step studies in pharmaceuticals, non-clinical, human pharmacokinetics, clinical efficacy, safety, and immunogenicity, scientifically and comprehensively verifying its overall similarity to Trulicity; the two are highly similar in quality, efficacy, safety, and immunogenicity, with no clinically meaningful differences. BA5101 is expected to improve the accessibility of GLP-1 receptor agonists and provide high-quality, affordable treatment options for a large number of type 2 diabetes patients worldwide. In recent years, the global burden of diabetes has continued to increase. Data from the International Diabetes Federation (IDF) shows that by 2024, there were approximately 38.5 million and 589 million adult diabetes patients (aged 20 to 79) in the US and globally, respectively; by 2050, these numbers are projected to increase to 43 million and 853 million. Public financial reports show that in 2025, global sales of Trulicity were approximately 4.276 billion US dollars, with US sales of 2.914 billion US dollars. Facing the vast market opportunities, the company has joined hands with its partner to integrate resources, achieve complementary advantages, and enhance the accessibility of GLP-1 receptor agonists together. The partner has a mature research and development, quality, registration, and sales team in the US, and is one of the most complete suppliers of injection sales pipelines in the country. Its sales platform in the US has rapidly expanded the US formulation approvals through cooperation and acquisitions, and has established a biosimilar pipeline; its biologics factory has passed an FDA site audit.