Phase 3 Clinical Trial Completed In China For Boan Biotech's Dulaglutide Injection BA5101. BLA To Be Filed Soon

Boan Biotech today announced the completion of a Phase 3 clinical trial (a comparative study of efficacy, safety, and immunogenicity) for its Dulaglutide Injection (BA5101) in China and the plan to submit a Biologics License Application (BLA) for the drug. The investigational drug is a biosimilar of Trulicity for glycemic control in adults with type 2 diabetes.

Dr. Dou Changlin, Chief Operating Officer and President of R&D at Boan Biotech, said: “Dulaglutide has demonstrated superiorities in treating type 2 diabetes, with a strong demand both in China and abroad. As far as we know, BA5101 is the first dulaglutide biosimilar in the world to have completed Phase 3 clinical trial. We are expediting the submission of its BLA in China. We’ve also started to seek registration for BA5101 overseas, so that patients around the world can benefit from it.”

A first-mover advantage for BA5101 thanks to strong CMC capabilities
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. In addition, due to its unique mechanism of action, dulaglutide usually does not cause hypoglycemia and can simultaneously improve multiple cardiovascular risk factors (CVRFs) such as weight gain and hyperlipidemia as well as long-term cardiovascular outcomes in patients. Besides, it also helps to protect the kidney¹. Several clinical studies have shown that there is better patient compliance with dulaglutide, as it can be conveniently administered once a week. 

The development of BA5101 has been following the guidelines for biosimilars in China, the U.S., Europe as well as other countries and regions. The Phase 3 clinical trial completed was a randomized, open-label, parallel-group and positive-control study comparing BA5101 with Trulicity  in Chinese adults with type 2 diabetes for efficacy and safety. The trial met all endpoints: BA5101 was shown to be able to quickly and stably reduce blood glucose and HbA1c levels, and to be comparable to Trulicity  in terms of efficacy, safety, and immunogenicity. In addition, a Phase 1 clinical trial of BA5101 also demonstrated high similarity with Trulicity  in pharmacokinetics, safety, and immunogenicity. This study was published in the journal Expert Opinion on Biological Therapy ².

It’s worth mentioning that the development of dulaglutide biosimilars as fusion proteins faces significant CMC (Chemistry, Manufacturing and Controls) challenges. Boan Biotech has successfully solved oxidation, truncation, charge heterogeneity and other challenges, and as a result, BA5101 is highly similar to Trulicity  in physicochemical property and bioactivity, a demonstration of the company’s strong CMC capabilities and R&D management skills.

Growing patient demand forebodes a promising global market for BA5101
Preventing and controlling diabetes is challenging in China and around the world. Data from the International Diabetes Federation (IDF) shows that 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, posing an enormous challenge to the healthcare system.

Given the huge unmet needs of diabetic patients and the superiorities of dulaglutide in treating diabetes in terms of efficacy and safety, Boan Biotech believes that BA5101 will have a promising market worldwide. Publicly available financial data shows that the global sales of Trulicity  in 2023 were approximately US$7.13B.

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 March 2024. 

Note: BA5101 was previously coded-named LY05008.