On August 5th, Gelunhui announced that the US Food and Drug Administration (FDA) has agreed to the clinical trial of the self-developed dulaglutide injection ("BA5101") in the United States.
BA5101 is a biosimilar of Trulicity (Chinese name: Duyida), which is intended for blood sugar control in type 2 diabetes patients. This product is the first dulaglutide injection produced by a Chinese company to be approved for clinical trials in the United States. Previously, BA5101, as the first Trulicity biosimilar declared for listing in China, has been accepted by the China National Medical Products Administration for review in May of this year.
Dulaglutide is a long-acting GLP-1 (glucagon-like peptide-1) receptor agonist that is administered once a week. Compared with other types of hypoglycemic drugs, dulaglutide can improve the function of pancreatic β cells, stabilize and effectively lower blood sugar and glycated hemoglobin (HbA1c) levels; in addition, its unique mechanism of action is unlikely to cause hypoglycemia, and can reduce weight, blood lipids and the risk of long-term cardiovascular disease, and also has a protective effect on the kidneys. Multiple clinical studies have also shown that dulaglutide has good safety, with low gastrointestinal adverse reactions, and once-weekly dosing can reduce the inconvenience for patients and improve medication compliance.
Trulicity is currently marketed in several countries and regions around the world, including the United States, the European Union, Japan, and China. The approved indications for this product worldwide include: (1) As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 and over with type 2 diabetes; (2) Used to reduce the risk of major cardiovascular events in adult patients with type 2 diabetes who have cardiovascular disease or multiple cardiovascular risk factors.
The development of BA5101 strictly follows the biosimilar research guidelines of the United States, the European Union, and China. It has been verified step by step in a series of pharmaceutical, non-clinical, human pharmacokinetic, clinical efficacy, safety and immunogenicity studies in China to confirm its overall similarity to the reference drug; BA5101 is highly similar to the reference drug in terms of quality, efficacy, safety and immunogenicity. Currently, BA5101 has become the first to enter the evaluation stage of the application for listing in China. The clinical trial approved in the United States is a randomized, open-label, single-dose, parallel-controlled three-arm clinical study aimed at comparing the pharmacokinetics, safety and immunogenicity of BA5101 and the reference drug in healthy subjects. The company plans to promote the clinical trials of this product and submit applications for listing in the United States and Europe, and plans to promote it to more countries and regions around the world.
There is a significant unmet need for diabetes patients worldwide. According to the latest data released by the International Diabetes Federation (IDF), there are approximately 0.537 billion adult diabetes patients (aged 20-79) worldwide in 2021, and this number is expected to increase to 0.784 billion in 2045. According to data from the American Diabetes Association (ADA), in 2021, 38.4 million Americans had diabetes, accounting for 11.6 % of the total US population. Public financial reports show that Trulicity's global and US market sales in 2023 were approximately US$7.13 billion and US$5.43 billion, respectively.
The company believes that BA5101 will have broad market prospects worldwide due to the huge demand for patients, the efficacy and safety advantages of dulaglutide in the treatment of diabetes, and other factors.
