Boan Biotech Starts Phase III Clinical Trial in China for Dulaglutide Injection (BA5101)

Luye Pharma Group announced on July 14 that its subsidiary Boan Biotech has started a Phase III clinical trial, which is a comparative clinical efficacy and safety study, for Dulaglutide Injection (BA5101) in China.

BA5101, a biosimilar to Trulicity^®, is a new long-acting glucagon-like peptide-1 (GLP-1) receptor agonist for glycemic control in adult patients with type 2 diabetes administered once a week. In addition to China, Boan Biotech is also planning to have the drug registered in other countries and regions.

The once-a-week GLP-1 receptor agonist provides multiple benefits for patients with diabetes

The completed pharmaceutical, non-clinical and human phase I clinical studies (comparative pharmacokinetic and/or pharmacodynamic studies) have shown that BA5101 has biological similarity with Trulicity^®.

The phase III clinical trial of BA5101 is a multicenter, randomized, open-label, parallel, and positive-control clinical study in Chinese adults with type 2 diabetes, to compare the efficacy, safety, immunogenicity and pharmacokinetic characteristics of BA5101 versus Trulicity^®.

Compared with other glucose-lowering drugs, Dulaglutide Injection can stimulate insulin secretion, suppress glucagon release, improve the functions of β-cells, and effectively lower blood sugar and HbA1c levels. With its unique mechanism of action, Dulaglutide Injection is not prone to causing hypoglycemia. It also helps to reduce multiple risk factors for cardiovascular diseases such as weight and blood lipids. Besides, a number of clinical studies show that Dulaglutide Injection is a safe and effective long-acting medication for type 2 diabetes. Its once-a-week regimen can reduce the inconvenience of frequent injections and the unwillingness of patients to receive the treatment, so as to improve patient compliance and their quality of life.

Today it’s very challenging to prevent and control diabetes both in China and around the world. According to Frost & Sullivan, there were over 400 million patients with type 2 diabetes globally in 2020, and the number will grow to approximately 586 million by 2030. In China, there were approximately 130 million patients with type 2 diabetes in 2020, which will grow to approximately 168 million by 2030.

Given the huge unmet needs of the patients, the future is promising for Dulaglutide Injection globally. Trulicity^® was first launched in the United States in 2014 and later in many other countries and regions including the European Union, Japan, and China. Trulicity^® is approved worldwide for the following indications: 1) for glycemic control in adults with type 2 diabetes; and 2) for reducing the risk of major adverse cardiovascular events in adults with type 2 diabetes who also have cardiovascular diseases or multiple risk factors for cardiovascular diseases. Publicly available financial data shows that global sales of Trulicity^® amounted to USD 6.47 billion in 2021, growing 28% YoY.

Boan Biotech serves the needs of patients with a robust and balanced portfolio

Boan Biotech develops, manufactures, and commercializes quality biologics, and provides innovative and accessible therapies in main therapeutic areas such as oncology, metabolism, autoimmune diseases, and ophthalmology in China and globally. Over the years, the company has gained a competitive edge unique to itself by leveraging its differentiated portfolio, comprehensive biopharmaceutical platforms, and increasingly sophisticated commercial capabilities.

Today, Boan Biotech already has a pipeline that includes multiple innovative antibodies protected internationally for intellectual property rights in addition to a number of biosimilars. A few biosimilar candidates close to commercial launch offer a clear path towards commercialization for the company in the short term, whereas many more innovative targets help to lay a solid foundation for the company’s long-term and sustainable growth. Luye Pharma is speeding up the strategic expansion of its biologics globally as one of the key business areas for the group’s transformation and upgrade through its subsidiary Boan Biotech.

Dr. Dou Changlin, R&D President and Chief Operating Officer of Boan Biotech, said: "At Boan Biotech, we do R&D based on market demand and the needs of patients. Dulaglutide Injection has a promising future in terms of market demand. The success of its phase I clinical trial and the fast initiation of its phase III clinical trial in China forebode the likelihood of it being the first biosimilar to Trulicity^® to get launched. We will also speed up the clinical studies and registration of BA5101 overseas. We are committed to providing quality and affordable biologics for patients with diabetes around the world and meeting the clinical needs of as many patients as possible."