On August 8, 2025, the official website of the National Medical Products Administration revealed that Dulaglutide Injection (Boyouping®), independently developed by Shandong Boan Biotechnology Co., Ltd. (hereinafter referred to as “Boan Biotech”), a holding subsidiary of Luye Pharma Group, was officially approved for marketing, intended for blood glucose control in adult patients with type 2 diabetes. This product marks the world’s first and currently only biosimilar of Trulicity® to receive marketing approval. To date, no other domestic dulaglutide injections have progressed to the Biologics License Application (BLA) stage in China.

The multiple clinical advantages of Dulaglutide Injection are particularly significant: besides effectively lowering blood sugar, it can improve the function of pancreatic β cells, reduce the risk of cardiovascular diseases, aid weight loss, protect kidney function, and have a low incidence of hypoglycemia and gastrointestinal adverse reactions. The drug, developed under the code name BA5101, acts as a long-acting GLP-1 (glucagon-like peptide-1) receptor agonist, requiring only one administration per week, significantly enhancing patient treatment compliance. Its original drug, Trulicity®, developed by Eli Lilly & Co., achieved global sales of up to $5.2535 billion in 2024, making it a blockbuster product in the field of diabetes treatment.

Globally, there were approximately 589 million adults with diabetes in 2024, and it is estimated that this number will reach 853 million by 2050. The vast patient population has driven up the market demand for GLP-1 drugs. In 2024, the market size of GLP-1 drugs in China reached RMB 6.376 billion.

There are more than one company globally working on dulaglutide biosimilars, with 9 products currently in development. Boan’s BA5101 is not only the first to apply for production domestically, but also the first globally to complete Phase III trials and receive approval, leading the way in terms of progress. No other domestic company has yet applied for the marketing of dulaglutide, giving Boan a head start. The clinical trial in the United States has also been approved, and internationalization is progressing simultaneously.

With the advent of biosimilars, drug prices will naturally decrease. Although Eli Lilly’s original research is excellent, it is expensive. Once domestic drugs are available, domestic patients will finally be able to afford and access high-quality weekly treatments.

Currently, there are three patents listed on the China Marketed Drug Patent Information Registration Platform for Eli Lilly’s Dulaglutide Injection, as shown in the table below. Among them, Patent 1 (200480015953.X) and Patent 2 (201010508567.1) have both expired and become invalid on June 10, 2024, while Patent 3 (estimated expiration date: December 15, 2025) was fully invalidated by Boan Biotech on March 13, 2025. From this, it can be inferred that more and more companies may start to imitate Dulaglutide from now on.

References:

1. https://mp.weixin.qq.com/s/E4FL-SsiTbh8XtIyKQe4lg

2. https://finance.sina.com.cn/jjxw/2025-08-08/doc-infkhmtx5063615.shtml