Gelonghui, May 27丨Boan Biotech (06955.HK) announced that the marketing application for the company's self-developed dulasopeptide injection (BA5101) has been accepted by the Drug Evaluation Center of the China National Drug Administration.

BA5101 is a biosimilar to Trulicity for blood sugar control in adults with type 2 diabetes. As far as the company knows, BA5101 is currently the first Trulicity (Trulicity) biosimilar to be submitted for marketing in China. It is also the first Trulicity (Trulicity) biosimilar in the world to complete phase III clinical trials, leading the development progress. In addition to China, international registration and clinical trials of this product are also being actively promoted.

Duracopeptide is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist given once a week. Compared with other types of hypoglycemic agents, duropeptides can improve the function of pancreatic beta cells and stably and effectively reduce blood sugar and glycated hemoglobin (HbA1c) levels. Furthermore, its unique mechanism of action does not easily cause hypoglycemia, can reduce body weight, blood lipids, and the risk of long-term cardiovascular disease, and also has a protective effect on the kidneys. In addition, several clinical studies have shown that duropeptides can be administered once a week to reduce the inconvenience of patients when taking medication and increase compliance. As a fusion protein, pharmaceutical (CMC) development of biosimilar duropeptides is difficult and technical barriers are high. The company has overcome technical problems such as oxidation, fracture, and complex charge heterogeneity of dura peptides. BA5101 is highly similar to Trulicity (Trulicity) in terms of physico-chemical properties and biological activity, fully demonstrating the company's solid CMC development capabilities and strong comprehensive R&D management capabilities.