Boan Biotech announced that China’s National Medical Products Administration (NMPA) has granted marketing approval to its Boyouping (dulaglutide injection), indicated for glycemic control in adults with type 2 diabetes mellitus.

Boyouping is the first and only biosimilar to Trulicity approved for marketing in the world. In China, no other dulaglutide biosimilar is in the Biologics License Application (BLA) stage yet.

According to the company, the development of Boyouping strictly followed the regulatory guidelines for biosimilars in China, the US, 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 approval of Boyouping as the world’s first dulaglutide biosimilar demonstrates our strong R and D expertise, efficient product development capabilities, and commitment to building an international R and D system with highest standards. We will accelerate the development and launch of this product overseas as part of our efforts to deliver quality, affordable biologics for patients around the world,” Dr. said Dou Changlin, President of R and D and Chief Operating Officer at Boan Biotech.

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. Its once-weekly dosing frequency also helps reduce patient inconvenience and improve treatment adherence.

The drug has also been cleared by the US Food and Drug Administration (FDA) for clinical trials.

Boan Biotech is partnering with Shanghai Pharmaceutical Co., Ltd. (Shaphar) to commercialise this drug in the Chinese mainland. In June this year, Boan Biotech granted Shaphar the exclusive right to commercialize Boyouping in the Chinese mainland.

Jiang Hua, Chairlady and CEO at Boan Biotech, said: “We are working closely with Shaphar to accelerate the distribution of Boyouping by leveraging the strength of each other. We are among a small number of Chinese biopharmaceutical companies with the ability to develop, manufacture and commercialize pharmaceuticals.”   

The global sales of Trulicity were approximately USD 5.25 billion in 2024, according to publicly available data.