China’s First Domestically Developed Dulaglutide Injection Approved for Market Launch, Ushering in a New Landscape for GLP-1 Drugs​

On August 8, Boan Biotechnology announced that its independently developed Boyouping® (Dulaglutide Injection) has received market approval from the National Medical Products Administration (NMPA) for glycemic control in adults with type 2 diabetes, making it the world‘s first domestically produced biosimilar of dulaglutide.

Dulaglutide is a human glucagon-like peptide-1 (GLP-1) receptor agonist, sharing 90% amino acid sequence homology with endogenous GLP-1(7-37) . It activates intracellular cyclic adenosine monophosphate (cAMP) in beta cells, leading to glucose-dependent insulin secretion. Additionally, dulaglutide suppresses glucagon secretion and delays gastric emptying .

Several GLP-1 receptor agonists (GLP-1RAs) are already available in China for glycemic control in adults with type 2 diabetes. For the weight loss indication, China has approved GLP-1RAs including liraglutide, beinaglutide, semaglutide, tirzepatide, and mazdutide .

In a recent development on October 18, Novo Nordisk announced that the U.S. FDA approved Rybelsus (oral semaglutide) to reduce the risk of Major Adverse Cardiovascular Events (MACE) in high-risk adults with type 2 diabetes, further expanding the therapeutic applications of GLP-1-based drugs
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According to the International Diabetes Federation, approximately 589 million adults worldwide were living with diabetes in 2024, a number projected to rise to 853 million by 2050. Concurrently, the global population affected by overweight and obesity is also increasing, indicating a substantial and persistent market demand for GLP-1-based therapies . Furthermore, the core patent for Novo Nordisk‘s weight loss product semaglutide is set to expire in China in March 2026. After patent expiry, competition is expected to intensify with the entry of numerous biosimilars, deepening rivalry among pharmaceutical companies .

Current research and development in the GLP-1 field is advancing towards long-acting formulations, multi-target agonists, and oral dosage forms . Beyond diabetes and weight management, pharmaceutical companies are exploring the potential of GLP-1-based therapies in areas such as non-alcoholic fatty liver disease, cardiovascular diseases, and Alzheimer‘s disease .

The competition in the GLP-1 drug market is just beginning. With continuous innovation and optimization by pharmaceutical companies, more products and treatment options are expected to reach the market. SZEB  provides  related impurity reference standards, such as those for semaglutide and tirzepatide, supporting other firms in the R&D race and quality control for GLP-1 drugs.