TG103

Boan Biotech announced that China’s National Medical Products Administration (NMPA) has granted marketing approval to its Boyouping® (Dulaglutide Injection), indicated for glycemic control in adults with type 2 diabetes mellitus. Boyouping is the first and only biosimilar to Trulicity® approved for marketing in the world. In China, no other dulaglutide biosimilar is in the Biologics License Application (BLA) stage yet. Boan Biotech is partnering with Shanghai Pharmaceutical Co., Ltd. (Shaphar) to commercialize this drug in the Chinese mainland. Overcoming CMC challenges to ensure biosimilarity Dulaglutide is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist administered once a week. It improves pancreatic β-cell function and stably and effectively lowers blood glucose and HbA1c levels. In addition to glycemic control, dulaglutide also offers other clinical benefits, such as a reduced risk of major adverse cardiovascular events, weight loss, renal protection, a low incidence of hypoglycemia, and mild gastrointestinal adverse reactions1,2. Its once-weekly dosing frequency also helps reduce patient inconvenience and improve treatment adherence. As a peptide-Fc fusion protein, dulaglutide has a complex structure that makes the CMC (chemistry, manufacturing, and controls) development of a biosimilar particularly challenging. Boan Biotech has strong expertise in CMC development. The company’s development platform was powerful in controlling the structural modifications of the fusion protein’s GLP-1 moiety, such as its truncation, hydroxylation, oxidation, formylation, and pyruvoyl acylation. The company’s efficient analytical platform allowed the development of proprietary methods for monitoring and controlling these critical quality attributes. A comprehensive quality control strategy enabled the company to overcome CMC challenges during process development and comparability assessment, leading to the approval of Boyouping for marketing in China. Additionally, the drug has also been cleared by the U.S. Food and Drug Administration (FDA) for clinical trials. The development of Boyouping strictly followed the regulatory guidelines for biosimilars in China, the U.S., and the EU. Its overall similarity to Trulicity has been established by evidence from a series of analytical, non-clinical, human pharmacokinetics, and clinical studies. The two products were shown to be highly similar in quality, efficacy, safety, and immunogenicity, with no clinically meaningful differences. In China, Boyouping and Trulicity were compared in two head-to-head pivotal clinical trials: one is Phase 1, and the other is Phase 3. Results from the Phase 1 clinical trial have been published in the Expert Opinion on Biological Therapy3, and results from the Phase 3 clinical trial have been published in the Journal of Diabetes4. In the Phase 3 clinical trial, Boyouping was shown to be able to rapidly, stably and sustainably lower blood glucose levels and reduce body weight. It also demonstrated equivalent efficacy to Trulicity as well as a safety, immunogenicity and pharmacokinetic profile comparable to the reference product in Chinese patients with type 2 diabetes mellitus4.   Dr. Dou Changlin, President of R&D and Chief Operating Officer at Boan Biotech, said: “The approval of Boyouping as the world’s first dulaglutide biosimilar demonstrates our strong R&D expertise, efficient product development capabilities, and commitment to building an international R&D system with highest standards. We will accelerate the development and launch of this product overseas as part of our efforts to deliver quality, affordable biologics for patients around the world.” Serving hundreds of millions of patients through partnerships China has the largest diabetic population among all countries, accounting for 1/4 of the global total. Worldwide there were 589 million adults aged 20 to 79 living with diabetes in 2024, and 148 million of them were in China. These numbers were projected to rise to 853 million and 168 million, respectively, by 20505. Driven by the huge unmet needs, the market looks promising for long-acting GLP-1 drugs. The size of the market for GLP-1 drugs in China was approximately RMB 6.376 billion in 2024, according to data from IQVIA. And the global sales of Trulicity were approximately USD 5.25 billion in 2024, according to publicly available data6. To address the extensive and growing patient needs, in June this year, Boan Biotech granted Shaphar the exclusive right to commercialize Boyouping in the Chinese mainland. The two parties will work together to increase both the accessibility and the reach of the drug. As a leading distributor of pharmaceuticals in China, Shaphar has established a nationwide distribution network covering over 70,000 healthcare institutions across 25 provinces, with a sales & marketing team of nearly 1,000 people. With its strong expertise in integrated sales & marketing across channels as well as its extensive distribution network, the company will distribute Boyouping to hospitals, retail pharmacy chains, and Direct-to-Patient (DTP) pharmacies throughout China at the fastest speed possible.  Jiang Hua, Chairlady and Chief Executive Officer at Boan Biotech, said:  “We are working closely with Shaphar to accelerate the distribution of Boyouping by leveraging the strength of each other. We are among a small number of Chinese biopharmaceutical companies with the ability to develop, manufacture and commercialize pharmaceuticals. Currently we are in a period of high-speed growth, as some of our first products have been launched one after another. We will continue to enhance our commercial capabilities and speed up the process to unleash the clinical value and market potential of our products through a hybrid model that combines in-house operations with strategic partnerships. This is in line with our goal to reduce the burden of disease for patients and improve public health.”  About Boan Biotech Boan Biotech is a fully-integrated biopharmaceutical company developing, manufacturing, and marketing biologics, with a focus on oncology, autoimmune diseases, ophthalmology, and metabolic diseases. The company's drug discovery activities revolve around multiple platforms: Human Antibody Transgenic Mouse and Phage Display Technology Platform, Bispecific T-cell Engager Technology Platform, ADC Technology Platform and Cell Therapy Platform. Boan Biotech operates across the entire value chain of the industry covering antibody discovery, cell line development, upstream and downstream process development, analytical and bio-analytical method development, technology transfer, non-clinical research, clinical research, regulatory affairs and registration, and commercial production. In the cell therapy field, Boan Biotech focuses on a new generation of enhanced and regulated CAR-T technology, developing safer, more effective, and affordable treatments for patients. Boan Biotech’s portfolio includes four products approved for marketing. Its pipeline includes one investigational drug under review for its marketing application, multiple novel biologics as drug candidates protected for their international intellectual property rights, and biosimilar candidates. In addition to China, the company is also developing biopharmaceutical products in overseas markets, including the U.S., the EU, and Japan. With a differentiated portfolio and well-established commercial capabilities, Boan Biotech operates across the industry’s value chain from research and development to manufacturing and commercialization, laying a solid foundation for long-term, high-quality growth in the future. References： 1. Hertel C Cerstein, Helen M Colhoun, Gilles R Dagenais, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial [J]. Lancet. https://doi-org.libproxy1.nus.edu.sg/10.1016/S0140-6736(19)31149-3 2. Prescription Information for Dulaglutide Injection 3. Zhang Q et al. Pharmacokinetic similarity study comparing the biosimilar candidate, LY05008, with its reference product dulaglutide in healthy Chinese male subjects. Expert Opin Biol Ther. 2023 Jul-Dec;23(8):727-735. doi: 10.1080/14712598.2023.2189009. Epub 2023 Mar 13. PMID: 36880118. 4. Li Liu et al. Efficacy and Safety of Dulaglutide Biosimilar LY05008 Versus the Reference Product Dulaglutide (Trulicity) in Chinese Adults With Type 2 Diabetes Mellitus: A Randomized, Open-Label, Active Comparator Study. Journal of Diabetes. 2025 Apr;17(4):e70077. doi: 10.1111/1753-0407.70077. 5. International Diabetes Federation. https://diabetesatlas.org/.Accessed on August 4, 2025 6. Eli Lilly and Company 2024 Annual Report. https://investor.lilly.com/static-files/ff06ed54-9f64-4b7f-8529-c0278d635eac