The board of directors of Shandong Boan Biotechnology Co., Ltd. announced that the Group's in-house developed Dulaglutide Injection ("BA5101") has completed the patient enrollment for its phase 3 clinical trial (a comparative study of efficacy and safety) in China. BA5101 is a biosimilar of Trulicity developed by the Group, for the treatment of adults with insufficiently controlled type 2 diabetes mellitus. This phase III clinical trial of BA5101 that has completed the patient enrollment is a randomized, open-label, parallel-group and positive-controlled clinical study that compares the clinical efficacy and safety of BA5101 with Trulicity®?

in Chinese adult patients with type 2 diabetes. It will further compare the efficacy, safety, immunogenicity and pharmacokinetic ("PK") characteristics of BA5101 with TrULicity after multiple subcutaneous injections in Chinese adult patients with type2 diabetes. Dulaglutide is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist administered once a week.

Compared with other glucose-reducing drugs, Dulaglutide can improve pancreatic islet beta cells function, stably and effectively reduce blood glucose and HbA1c levels. In addition, due to its unique mechanism of action, Dulaglutide will simultaneously improve multiple risk factors for cardiovascular diseases such as weight gain, hyperlipidemia/blood lipids and long-term cardiovascular disease risks, and is not prone to causing lower hypoglycemia rate. It also has a protective effect on the kidney.

Moreover, several clinical studies have shown that patients taking Dulaglutide once a week have higher compliance because of the convenience of use. The development of BA5101 follows the guidelines for biosimilars in China, the United States, Europe, etc. The completed preclinical comparative studies show that BA5101 is highly similar to Trulicity® in terms of physicochemical properties and biological activities.

As a fusion protein, the development of Dulaglutide biosimilars is difficult in terms of chemistry, manufacturing and control (CMC). The Group has overcome the technical problems such as oxidation, truncation and complex charge heterogeneity of Dulaglutide. The results of the completed phase I clinical trial in China show that BA5101 has highly similar PK characteristics, safety and immunogenicity with Trulicity®, indicating that it has clinical similarity with the reference product.

The clinical results have been published in the journal of Expert Opinion on Biological Therapy published by Taylor & Francis. The Company believes that BA5101 will have broad market prospects on a global scale, driven by a combination of factors such as large clinical unmet need and clear clinical value.