First in China: BLA for Boan’s Dulaglutide Injection Accepted

Boan Biotech announced today that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for its Dulaglutide Injection (BA5101), a drug for glycemic control in adults with type 2 diabetes. This is the first biosimilar of Trulicity^® to have a BLA filed in China.Overseas, Boan Biotech is also preparing to register the drug and conduct clinical trials for it.

Dulaglutide is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist administered once a week. Compared with other glucose lowering medications, dulaglutide can improve the functions of β-cells, and stably and effectively lower blood glucose and HbA1c levels. Additionally, due to its unique mechanism of action, the drug does not easily cause hypoglycemia and can reduce body weight, blood lipids, and the risk of long-term cardiovascular diseases. Besides, it also helps to protect kidneys¹. Several clinical studies have shown that there is better patient compliance with dulaglutide, as it can be conveniently administered once a week.

Dulaglutide's complex structure as a fusion protein poses significant challenges to CMC (chemistry, manufacturing, and controls). By leveraging its extensive CMC experience and expertise, Boan Biotech was able to overcome the technical hurdles to the oxidation, truncation, and charge heterogeneity of dulaglutide, to advance BA5101 from preclinical to clinical studies and make it the first biosimilar of Trulicity in the world to have completed a Phase 3 clinical trial.

The development of BA5101 has been strictly following the guidelines for biosimilars in China, the U.S., and the EU. Two pivotal clinical studies comparing BA5101 with the reference drug Trulicity met all endpoints.

The Phase 1 clinical trial demonstrated that BA5101 had high similarity with Trulicity in pharmacokinetics, safety, and immunogenicity. This study was published in the journal Expert Opinion on Biological Therapy².

The Phase 3 clinical trial demonstrated that BA5101 was able to quickly and stably reduce blood glucose and HbA1c levels, and was comparable to Trulicity in terms of efficacy and safety.

In China and around the world, there is a huge number of diabetic patients with significant unmet medical needs. According to the latest data from the International Diabetes Federation (IDF), globally 537 million people (age 20-79) lived with diabetes in 2021, and the number was expected to reach 784 million by 2045. China had 141 million diabetic patients (age 20-79) in 2021, more than any other country in the world, accounting for over 1/4 of the global total, which was projected to reach 174 million by 2045³.

Driven by the demand of patients, the prospect of long-acting GLP-1 drugs in the marketplace is very promising. Publicly available data shows that the global sales of Trulicity in 2023 were approximately USD 7.13 billion⁴.

Dr. Dou Changlin, Chief Operating Officer and President of R&D at Boan Biotech, said: " BA5101 is the fourth biologic of us for which a BLA has been filed in China. We will cooperate with the Chinese regulators in the review process, and will also speed up the efforts to register and file an IND for it overseas. BA5101 has the potential to become the first biosimilar of Trulicity approved for marketing in the world. We believe it will be a high-quality, affordable treatment option for diabetic patients.”

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/10.1016/S0140-6736(19)31149-3
2. Qin Zhang, Cheng Sun, Jinying Wu, et al. Pharmacokinetic similarity study comparing the biosimilar candidate, LY05008, with its reference product dulaglutide in healthy Chinese male subjects [J]. Expert Opinion on Biological Therapy. https://doi.org/10.1080/14712598.2023.2189009
3. International Diabetes Federation. https://diabetesatlas.org/.Accessed in May 2024
4. Eli Lilly and Company 2023 Annual Report. https://investor.lilly.com/static-files/b5c56281-bc31-48c3-9e63-5e6cd588dff5. Accessed in May 2024