Boan Biotech has completed the enrolment of patients in China in its Phase III clinical trial of Dulaglutide Injection (BA5101) to treat adult patients with type 2 diabetes.
BA5101 is used for glycemic control in adult subjects with insufficiently controlled type 2 diabetes.
The parallel-group, positive-controlled, randomised, open-label clinical study will compare the safety and clinical efficacy of BA5101 with its biosimilar, Trulicity, in these patients in China.
After administering multiple subcutaneous injections to the patients, the study will also compare the immunogenicity, pharmacokinetics, efficacy, and safety of BA5101 with Trulicity.
Boan Biotech chief operating officer and research and development president Dr Dou Changlin said: “As far as we know, BA5101 is the world’s first Phase III clinical trial of a Dulaglutide biosimilar, and is expected to be the first biosimilar of Trulicity to be commercialised.
“Dulaglutide has a wide range of clinical needs, and it is expected to provide high quality and affordable biological drugs for type 2 diabetes patients in China after its launch.
“At the same time, Boan Biotech has started work regarding overseas clinical trials and registration for BA5101, in order to further expand its international business.”
Administered once a week, Dulaglutide is a long-acting, glucagon-like peptide-1 (GLP-1) receptor agonist. It improves the functions of β-cells and reduces levels of blood glucose and HbA1c.
At the same time, it can also improve multiple risk factors for cardiovascular diseases, such as weight gain and hyperlipidemia/blood lipids.
In preclinical comparative studies, BA5101 was found to be highly similar to Trulicity in terms of biological activities and physicochemical properties.
