BOAN BIOTECH Grants U.S. Rights for BA5101, the First Trulicity® Biosimilar, in Licensing Agreement

Bulletin Express
06/11

Shandong Boan Biotechnology Co., Ltd. (BOAN BIOTECH) has signed a licensing agreement that transfers the U.S. commercialization rights of BA5101 (dulaglutide injection) to an undisclosed partner. The partner will handle Biologics License Application (BLA) submission, marketing, and sales, while BOAN BIOTECH will receive an upfront payment, milestone fees, and sales-based commissions.

BA5101 was independently developed and received marketing approval in China in August 2025 as the world’s first—and currently only—biosimilar to Eli Lilly’s Trulicity®. The product has also secured clearance to begin clinical trials in the United States and is slated for future rollout in additional markets.

Dulaglutide is a once-weekly GLP-1 receptor agonist that not only lowers blood glucose and HbA1c but also offers cardiovascular risk reduction, weight loss, renal protection, and a low incidence of hypoglycemia. Similarity studies confirm that BA5101 matches Trulicity® in quality, efficacy, safety, and immunogenicity across analytical, non-clinical, pharmacokinetic, and clinical evaluations.

Market potential remains significant: according to the International Diabetes Federation, 38.50 million U.S. adults and 589.00 million adults worldwide were living with diabetes in 2024, with projections of 43.00 million and 853.00 million, respectively, by 2050. Public data show Trulicity® generated USD 4.28 billion in global sales in 2025, of which USD 2.91 billion came from the U.S. market.

The U.S. partner—equipped with R&D, quality assurance, registration, and a broad injectable portfolio—has expanded rapidly via partnerships and acquisitions and operates an FDA-inspected biologics manufacturing facility. BOAN BIOTECH and the partner aim to leverage their combined capabilities to increase patient access to an affordable dulaglutide option in the United States.

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