Boan's Dulaglutide Cleared By FDA For Clinical Trials

Boan Biotech today announced that it has received the U.S. FDA clearance for clinical trials of its dulaglutide injection (BA5101). BA5101 is a proposed biosimilar to Trulicity intended for glycemic control in patients with type 2 diabetes. It is the first dulaglutide biosimilar developed in China to be cleared for clinical investigation in the U.S., and also the first to submit a Biologics License Application (BLA) in China, which was accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) in May this year.

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 helps to protect kidneys¹. Multiple clinical studies have also shown that dulaglutide has a good safety profile with low gastrointestinal adverse reactions, and the weekly administration helps to reduce the patient inconvenience and improve patient compliance.

Trulicity is commercially available in several countries and regions including the U.S., EU, Japan, and China. It is indicated: (1) as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus; and (2) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.

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 drug, Trulicity, has been established by evidence from a series of analytical, non-clinical, comparative human pharmacokinetics, and comparative clinical efficiency studies. BA5101 has been shown to be highly similar to the reference drug in terms of quality, efficacy, safety, and immunogenicity. The BLA of BA5101 is under review in China. The first proposed clinical study in the U.S. will be a randomized, open-label, single-dose, three-arm and parallel-controlled study to evaluate the pharmacokinetics, safety, and immunogenicity of BA5101 with the reference drugs in healthy subjects. The company plans to conduct clinical studies and submit marketing authorization applications in the U.S. and Europe, and also plans to market it in other countries and regions as well.

Globally there is a huge number of diabetic patients with significant unmet needs. According to the latest data from the International Diabetes Federation (IDF), there were 537 million people (ages 20-79) living with diabetes worldwide in 2021, and the number is expected to reach 784 million by 2045.² Data from the American Diabetes Association (ADA) shows that there were 38.4 million Americans living with diabetes in 2021, accounting for 11.6% of the U.S. population.³ Publicly available information shows that the sales of Trulicity were approximately $7.13 billion worldwide and $5.43 billion in the U.S. ⁴

Dr. Dou Changlin, Chief Operating Officer and President of R&D at Boan Biotech, said: " The U.S. FDA clearance of BA5101 for clinical trials marks another major step for us in our global strategy. The CMC (chemistry, manufacturing, and controls) development of dulaglutide is very challenging. But we have managed to overcome the challenges thanks to our strong CMC capabilities. We are ahead of the competition both in China and abroad with respect to the development of BA5101. We look forward to accelerating our overseas expansion and providing a high-quality and more affordable biologic product to diabetic patients worldwide.”

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 on July 30th, 2024
^3.American Diabetes Association. Statistics About Diabetes. Available at: https://diabetes.org/about-diabetes/statistics/about-diabetes. Accessed on July 30th, 2024
^4.Eli Lilly and Company 2023 Annual Report. Available at: https://investor.lilly.com/static-files/b5c56281-bc31-48c3-9e63-5e6cd588dff5. Accessed on July 30th, 2024