August 15, 2025
Source: drugdu
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Recently (August 8), Luye Pharma's subsidiary, Boan Bio, officially received marketing approval from the National Medical Products Administration for its independently developed dulaglutide injection (trade name: Boyuping®), specifically for blood sugar control in adults with type 2 diabetes. As the world's first and currently the only approved biosimilar to Trulicity®, Boyuping® fills a gap in the domestic market – previously, no other domestically produced similar product had entered the marketing authorization application stage. This marks a major breakthrough for Chinese companies in the GLP-1 biosimilar field.
As a long-acting GLP-1 receptor agonist, dulaglutide regulates insulin secretion by mimicking glucagon-like peptide-1, achieving stable blood sugar control. Its core advantage lies in its high compliance design, requiring only a once-weekly dosing regimen. It also offers multiple clinical benefits: in addition to lowering blood sugar, it can significantly reduce the risk of cardiovascular events, reduce weight, protect renal function, and has a low incidence of hypoglycemia and gastrointestinal adverse reactions.
China is the world's largest country with diabetes, with 148 million patients aged 20-79 (accounting for 25% of the global total), a number projected to increase to 168 million by 2050. This large patient population is driving the rapid growth of the GLP-1 drug market. Yaozhi Data [Drug Terminal Sales Analysis System] shows that the Chinese market size will exceed 10 billion yuan in 2024.
However, original drug brands have long held a monopoly on the market. Eli Lilly's original drug Trulicity® will generate global sales of $5.25 billion in 2024, and together with semaglutide and liraglutide, it holds over 80% of the GLP-1 market share in China. The launch of Boyuping® has broken this deadlock. Among the dulaglutide biosimilars currently under development in China, only Boan Biopharma has entered the commercialization stage, while competing products from Lepu Medical and Shuanglu Pharmaceutical are still in late-stage clinical trials. This means that Boan Biopharma will enjoy at least two years of market exclusivity.
Its pricing strategy also has disruptive potential: the unit price of the original drug Duyida® has dropped from 417 yuan in 2019 to 128.7 yuan in 2023. The entry of the domestically produced Boyuping® is expected to further lower prices, benefiting a wider patient population.
To accelerate market penetration, in June of this year, Boan Biopharma licensed exclusive commercialization rights in mainland China to Shanghai Pharmaceuticals Holdings, accelerating the nationwide expansion of Boyuping® into hospital channels, retail pharmacy networks, and direct-to-consumer specialty pharmacies. Simultaneously, internationalization efforts are also underway. Boyuping® has received clearance for clinical trials in the United States and will build global market competitiveness through future overseas launches.
With the normalization of medical insurance negotiations and the extension of centralized procurement policies to biopharmaceuticals (such as pilot programs in Anhui and Guangdong), domestically produced GLP-1 drugs are expected to seize the grassroots market through their price advantage. In the future, long-acting hypoglycemic drugs will not only be tools for blood sugar management but also an important option for comprehensive cardiovascular risk intervention. The launch of Boyuping® provides Chinese patients with diabetes with a new treatment option that combines clinical value and affordability.
https://news.yaozh.com/archive/45892.html
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