Phase 3 Trial Results of Boan Biotech’s Dulagutide Injection Published in Journal of Diabetes

April 21, 2025, Yantai -- The Phase 3 trial results of Boan Biotech’s BA5101 (Dulagutide Injection, formerly code-named LY05008) were recently published in Journal of Diabetes. 

BA5101 is a biosimilar to Trulicity® indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The Biologics License Application (BLA) of BA5101 is under review in China currently. It is the world’s first and only biosimilar to Trulicity to submit the BLA.

Link: https://onlinelibrary.wiley.com/doi/10.1111/1753-0407.70077

Dulaglutide is a long-acting, once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist. Compared with other glucose-lowering medications, dulaglutide can improve β-cell function and achieve stable and effective reductions in blood glucose and HbA1c levels. In addition, due to its unique mechanism of action, the drug is less likely to cause hypoglycemia and can reduce body weight, blood lipids, and the risk of long-term cardiovascular complications. It also demonstrates kidney benifits¹ . Multiple clinical studies have also shown that its weekly administration helps to reduce the patient inconvenience and its gastrointestinal adverse reactions are relatively mild, both of which contribute to better patient compliance.

The development of BA5101 strictly followed relevant guidelines for biosimilars in China, the U.S., and the EU. The drug’s overall similarity to the reference product, Trulicity, has been established by evidence from a series of analytical, non-clinical, comparative human pharmacokinetics, and comparative clinical studies. BA5101 has been shown to be highly similar to the reference product in terms of quality, efficacy, safety, and immunogenicity.

The Phase 3 study of BA5101, led by Professor Guo Lixing from Beijing Hospital, is a multi-center, randomized, open-label, active comparator study designed to compare the efficacy and safety between BA5101 and Trulicity in treating Chinese adults with type 2 diabetes mellitus. In this study, 440 patients were randomly assigned 1:1 to receive a subcutaneous injection of 1.5 mg BA5101 (n=222) or Trulicity(n=218) once weekly for 24 weeks.

The primary endpoint was the mean change in HbA1c from baseline to Week 24. The secondary endpoints included the mean change in HbA1c from baseline to Week 12; the proportion of patients who had achieved HbA1c ≤ 6.5% at Weeks 12 and 24; and the mean change in body weight, fasting plasma glucose (FPG) level, and 2-h postprandial plasma glucose (PPG) level from baseline to Weeks 12 and 24. Safety, PK, and immunogenicity profiles were also included for data analysis. All the endpoints in the study were met. BA5101 was shown to rapidly, stably and sustainably lower blood glucose level as well as reduce body weight. Overall, it demonstrated equivalent efficacy to Trulicity in Chinese patients with type 2 diabetes mellitus as well as comparable safety, immunogenicity, and PK profiles against Trulicity.

The global diabetic population is huge. According to the latest data from the International Diabetes Federation (IDF), 589 million adults aged 20 to 79 were living with diabetes worldwide in 2024, a number projected to rise to 853 million by 2050. China has the largest diabetic population of any country, with 148 million adults affected in 2024 -- accounting for 25% of the global total. This figure is expected to grow to 168 million by 2025².  Amid such significant unmet medical needs, the market outlook for long-acting GLP-1 receptor agonists is increasingly promising. Publicly available data show that the global sales of Trulicity reached approximately USD 5.25 billion in 2024³. 

Dr. Changlin Dou, President of R&D and Chief Operating Officer at Boan Biotech, said: “The nature of dulaglutide as a peptide-Fc fusion protein presents formidable CMC challenges in any biosimilar development. Through a rigorous clinical program, the overall similarity between BA5101 and Trulicity has been demonstrated. BA5101’s Phase 1 results were published in Expert Opinion on Biological Therapy in 2023⁴ . The publication of these two articles reflects the recognition by international scientific community of the quality and data of the clinical studies of BA5101. We are ahead of the global competition with respect to the development of BA5101 as it is the first dulaglutide biosimilar allowed to proceed to clinical study in the U.S.. We look forward to its ex-China development and launch so that we can offer diabetic patients around the world an affordable, high-quality treatment option.” 

References：

1. Hertel C Cerstein, Helen M Colhoun, Gilles R Dagenais, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial [J]. Lancet. https://doi.org/10.1016/S0140-6736(19)31149-3
2. International Diabetes Federation. https://diabetesatlas.org/.Accessed in April 2025
3. Eli Lilly and Company 2023 Annual Report. https://investor.lilly.com/static-files/ff06ed54-9f64-4b7f-8529-c0278d635eac. Accessed in April 2025
4. Qin Zhang, Cheng Sun, Jinying Wu, et al. Pharmacokinetic similarity study comparing the biosimilar candidate, LY05008, with its reference product dulaglutide in healthy Chinese male subjects [J]. Expert Opinion on Biological Therapy. https://doi.org/10.1080/14712598.2023.2189009