Boan Biotech’s Dulaglutide Injection (BA5101) Approved for Clinical Trials in China

September 27, 2021, Shanghai, China – Luye Pharma Group today announced that Dulaglutide Injection (BA5101) developed in-house by Boan Biotech, a subsidiary of the Group, has obtained approval from the Centre for Drug Evaluation of China’s National Medical Products Administration to begin clinical trials in the country. Boan Biotech is building a differentiated and diverse product portfolio, covering biosimilars, innovative antibodies and cell therapies. The company is rapidly advancing the development of various drug candidates from its rich product pipeline.

BA5101, a biosimilar to Trulicity^®, is a new generation long-acting glucagon-like peptide-1 (GLP-1) receptor agonist with a once-weekly dosing regimen, for glycemic control in adult patients with type 2 diabetes.

Compared with other glucose-reducing drugs, dulaglutide injection has multiple clinical advantages: it can promote insulin secretion, suppress glucagon secretion, improve β-cell function and reduce glycemia and HbA1c levels. With its unique mechanism of action, dulaglutide injection rarely causes hypoglycemia. It also can help reduce weight, blood lipid levels and other risk factors that may lead to cardiovascular diseases. A number of clinical studies show that dulaglutide injection is a safe and effective long-acting type 2 diabetes medication. Its once-a-week dosing regimen can reduce the inconvenience of frequent injections and the unwillingness of patients to receive treatment, leading to improved medication compliance and quality of life.

Preclinical studies have shown that BA5101 is highly similar to Trulicity^® in terms of pharmacology, pharmacokinetics and toxicology. Boan Biotech is advancing the development of BA5101 and planning to register the drug in other countries and regions.

Diabetes is a serious disease both in China and around the world, creating an urgent need for more control and prevention measures. According to data from the International Diabetes Federation, in 2019, approximately 463 million adults aged 20 to 79 around the world were living with diabetes; this will rise to 700 million[i] by 2045. China has a large diabetes population, with the prevalence among people aged 18 and above as high as 11.2%².

Given the large unmet patient needs in this disease area, dulaglutide injection has broad market potential globally. Trulicity^® was first launched in the United States in 2014 and later launched in many other countries and regions, such as the European Union, Japan and China. Trulicity^® is approved worldwide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors. According to public financial reports, global sales of Trulicity^® amounted to USD 5.07 billion in 2020 with an annual growth rate of 23%[ii].

“The development of dulaglutide injection is an important step forward in meeting the clinical needs of patients. By developing a quality and affordable biological therapy, we aim to improve drug accessibility for diabetes patients around the world,” said Dr. Dou Changlin, R&D President and Chief Operating Officer of Boan Biotech.

By leveraging its strong in-house innovation capabilities, Boan Biotech has built a diverse pipeline consisting of innovative biologic and biosimilar product candidates, including BA5101. The company’s R&D pipeline now has more than 10 innovative antibodies with international intellectual property protection, and a number of biosimilars under development. As one of the core business areas for the Group's transformation, Luye Pharma is continuously increasing investments in Boan Biotech to speed up implementation of the Group’s global biopharmaceutical strategy.