Boan Biologics Receives IND Approval for Dulaglutide Biosimilar LY05008 in China

On September 27, the CDE website indicated that LY05008, developed by BoAn Biotechnology, a subsidiary of Luye Pharma, has been approved for clinical trials. It is a dulaglutide biosimilar indicated for the treatment of type 2 diabetes.

Source: CDE Official Website

GLP-1 receptor agonists have emerged as a new driver of rapid growth in the diabetes sector in recent years, with their market size already approaching half that of insulin products. Despite significantly higher prices compared to insulin, their clinical applications continue to expand, indicating enormous market potential.

Dulaglutide (Trulicity, Duyida), a once-weekly injectable glucagon-like peptide-1 (GLP-1) receptor agonist developed by Eli Lilly, received marketing approval in 2014 and has since become the globally best-selling GLP-1 receptor agonist antidiabetic drug, with sales reaching $5.07 billion in 2020.

In addition to being approved for the treatment of type 2 diabetes, Trulicity was approved by the FDA in 2020 to reduce the risk of major adverse cardiovascular events (MACE) in adult patients with type 2 diabetes who have established cardiovascular (CV) disease or multiple cardiovascular risk factors.

In China, Eli Lilly’s Trulicity (dulaglutide) received marketing approval in February 2019. According to the Insight database, no biosimilar marketing applications have been submitted to date, resulting in a relatively moderate competitive landscape. Only two biosimilars have initiated clinical trials: the first is SAL015 from Salubris, which commenced clinical development in August 2020, and the second is from Lepu Biopharma. BoAn Biotechnology follows closely behind these two, having already obtained clinical trial approval.

Competitive Details of Dulaglutide and Analogues (Insight)

Source: Insight Database (http://db.dxy.cn/v5/home/)