BOAN BIOTECH has announced it has entered into a licensing agreement with a partner concerning the US market rights for its dulaglutide injection, BA5101.

Under the terms of the agreement, the partner will be responsible for the commercialization of the product in the United States, which includes activities such as regulatory submissions and sales.

In return, BOAN BIOTECH will receive an upfront payment, milestone-based payments, and royalties on future sales.

BA5101 was developed in-house as part of the company's global development strategy and received marketing approval in China in August 2025.

It is recognized as the world's first and currently only biosimilar to Trulicity® (dulaglutide) that has been approved for market use.

The product has also received approval to conduct clinical trials in the United States and plans are in place for future commercialization across multiple countries and regions.

Dulaglutide is a long-acting GLP-1 (glucagon-like peptide-1) receptor agonist administered once weekly.

It works to improve pancreatic beta-cell function and provides stable, effective reduction of blood glucose and glycated hemoglobin (HbA1c) levels.

Beyond its primary role in glycemic control, dulaglutide offers several additional clinical benefits.

These include a reduction in major adverse cardiovascular events, weight loss, a protective effect on the kidneys, and a low incidence of hypoglycemia and gastrointestinal side effects.

The convenience of a once-weekly dosing regimen helps reduce the burden on patients and can improve treatment adherence.

In the US, Trulicity® is approved as an adjunct to diet and exercise to improve glycemic control in adults and children aged 10 years and older with type 2 diabetes.

It is also approved to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors.

The development of BA5101 strictly followed biosimilar guidelines from regulatory authorities in China, the United States, and the European Union.

A comprehensive, stepwise series of studies encompassing pharmaceutical quality, non-clinical data, human pharmacokinetics, clinical efficacy, safety, and immunogenicity scientifically confirmed its overall similarity to the reference product, Trulicity®.

The two products are highly similar in quality, efficacy, safety, and immunogenicity, with no clinically meaningful differences.

BA5101 has the potential to improve patient access to dulaglutide treatment, offering a high-quality and affordable new therapeutic option for the vast number of people globally living with type 2 diabetes.

The global burden of diabetes continues to rise significantly.

Data from the International Diabetes Federation (IDF) indicates that in 2024, there were approximately 38.5 million and 589 million adults (aged 20-79) with diabetes in the United States and worldwide, respectively.

These numbers are projected to increase to 43 million and 853 million by the year 2050.

Public financial reports show that in 2025, the global sales for Trulicity® were approximately $4.276 billion, with US sales accounting for $2.914 billion of that total.

Facing this substantial market opportunity, BOAN BIOTECH is collaborating with its partner to combine resources and complementary strengths with the shared goal of enhancing access to dulaglutide.

The partner possesses an established team in the US covering research and development, quality control, regulatory affairs, and sales, positioning it as one of the suppliers with the most comprehensive portfolio of injectable products in the region.

Its US-based sales platform has rapidly expanded its portfolio of approved drug applications through collaborations and acquisitions and has built a pipeline of biosimilar products.

The partner's biologics manufacturing facility has successfully passed an on-site inspection by the US Food and Drug Administration (FDA).