Boanbiodulaglutide injection BA5101 completed phase III clinical trial

Boambio announced that its self-developed dulaglutide injection (BA5101) has completed the enrollment of all subjects in the phase III clinical trial (safety and effectiveness comparison trial) in China.

BA5101 is a biosimilar to Trulicity® for glycemic control in adults with type 2 diabetes. This phase III trial was a randomized, open-label, parallel, positive controlled clinical trial comparing the efficacy and safety of BA5101 and Duxidar ® in Chinese adults with type 2 diabetes. To further compare the clinical efficacy, safety, immunogenicity and pharmacokinetics (PK) profiles of BA5101 and Dueidar ® after multiple subcutaneous injections in Chinese adults with type 2 diabetes.

Dulaglutide has multiple therapeutic advantages
Biosimilars are difficult to develop

Dulaglutide is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist that is administered once weekly. Compared with other types of antidiabetic drugs, dulaglutide can improve the function of islet β cells and stably and effectively reduce blood glucose and glycosylated hemoglobin (HbA1c) levels. In addition, its unique mechanism of action is less likely to cause hypoglycemia and leads to reductions in body weight, lipid profiles, and long-term cardiovascular disease risk, with renoprotection. Not only that, a number of clinical studies have shown that the once-weekly administration of dulaglutide can reduce the inconvenience of patients when taking medicine and improve their compliance.

BA5101 was developed in accordance with the research guidelines of biosimilars in China, the United States, and the European Union. BA5101 is highly similar to Trulicity® in terms of physicochemical properties and biological activities. As a fusion protein, the pharmaceutical development of dulaglutide biosimilar is difficult. Boan Bio has overcome the technical problems of dulaglutide in oxidation, fragmentation and charge heterogeneity. The results of the completed phase I clinical trial in China showed that BA5101 and Duyidar ® had highly similar PK profiles, safety and immunogenicity, indicating that BA5101 had clinical similarity to the reference drug. Related research results has already published in the journal ExpertOpiniononBiologicalTherapy2 Taylor&Francis group.

The situation of diabetes prevention and control is serious
Disease continues to rise globally

At present, the situation of diabetes prevention and control in China and even in the world is extremely serious. According to the latest data released by the International Diabetes Federation (IDF), there were about 537 million adults (20-79 years old) with diabetes in the world in 2021, and it is expected to increase to 643 million and 784 million in 2030 and 2045, respectively. In 2021, there were approximately 141 million adults (20 to 79 years of age) with diabetes in China, which is projected to increase to 164 million in 2030 and 174 million in 2045.3

Based on the above large unmet patient needs, Boambio believes that BA5101 will gain a broad market prospect worldwide. Public financial reports show that Trulicity® global sales in 2022 were approximately 7.44 billion US dollars, an increase of 15% compared to 2021.