The board of directors of Shandong Boan Biotechnology Co., Ltd. announced that the Phase 3 clinical trial (a comparative study of efficacy, safety, and immunogenicity) for Dulaglutide Injection ("BA5101") developed by the Company has been completed in China. The Company is planning to submit a Biologics License Application ("BLA") for the drug. BA5101 is a biosimilar of Trulicity®?

for glycemic control in adults with type 2 diabetes.BA5101 is the first dulaglutide biosimilar in the world to have completed Phase 3 clinical trial as far as the Company is aware, and leads in development progress. 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 the functioning of pancreatic islet beta cells, stably and effectively reduce blood glucose and HbA1c levels.

Due to its unique mechanism of action, Dulaglutide will improve multiple risk factors for cardiovascular diseases simultaneously such as weight gain, hyperlipidemia/blood lipids and long-term cardiovascular disease risks, and is not prone to causing lower rate of hypoglycemia. It can also protect the kidney. Moreover, several clinical studies have shown that taking Dulaglutide once a week can also encourage consumption regularity among patients as a result of such convenience of use.

The development of BA5101 follows the guidelines for biosimilars in jurisdictions including China, the United States and Europe. The completed Phase 3 clinical trial was a randomized, open-label, parallel group and positive control study comparing the efficacy and safety of BA5101 with Trulicity ®? among Chinese adults with type 2 diabetes.

The trial met all endpoints: BA5101 was shown to be able to quickly and stably reduce blood glucose and Hb a1c levels which is comparable with Trulicity®? in terms of efficacy, safety, and Immunogenicity. In addition, the outcome of a Phase 1 clinical trial of BA5101 was also demonstrated to be highly similar to Trulicity®?

in pharmacokinetics, safety, and immunogenity. The clinical results have been published in the journal of Expert Opinion on Biological Therapy published by Taylor & Francis. The development of Dulaglutide biosimilars as fusion proteins faces significant CMC (Chemistry, Manufacturing and Controls) challenges.

The Company has successfully resolved oxidation, truncation, charge heterogeneity and other challenges, and as a result, BA5101 is highly similar to Trulicity?? in physicochemical property and bioactivity. This demonstrates the strong CMC capabilities and R&D management skills of the Company.

Preventing and controlling diabetes is challenging in both China and worldwide. Data from the International Diabetes Federation (IDF) shows that globally, 537 million people (aged 20-79) had diabetes in 2021, and the number is expected to reach 784 million by 2045. China had 141 million diabetic patients (aged 20-79) in 2021, more than any other country in the world, accounting for over a quarter of the total globally, which was projected to reach 174 million by 2045, posing an enormous challenge to the healthcare system.

Publicly available financial data shows that the global sales of Trulicity®? in 2023 were approximately USD 7.13 billion. Given the huge unmet needs of diabetic patients and the superiorities of dulaglutide in treating diabetes in terms of efficacy and safety, the Company believes that there is a promising global market for BA5101.