IND Application for Boan Biotech’s TL1A/IL-23 Bispecific Antibody BA2201 Accepted in China

Boan Biotech today announced that the Investigational New Drug (IND) application for BA2201 has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). Developed in-house by Boan Biotech, BA2201 is a long-acting bispecific antibody targeting TL1A and IL-23 and is intended for the treatment of inflammatory bowel disease (IBD), including ulcerative colitis and Crohn’s disease. The company believes that this drug candidate is expected to become one of the first bispecific antibodies targeting TL1A and IL-23 to enter clinical development in China.

IBD is a group of chronic, relapsing, and non-specific inflammatory disorders of the intestinal tract, and long-term disease management for patients remains challenging.¹ Despite advances in targeted therapies, approximately one third of the patients do not respond to initial treatment, and about half of them will lose response over time.² In addition, ongoing inflammation may result in progressive bowel damage and complications over time and contribute to the development of intestinal fibrosis.^3,4

BA2201 is designed to target both IL-23 (p19) and TL1A, two key pathways involved in disease pathogenesis. IL-23 (p19) is a clinically validated therapeutic target for IBD. TL1A/DR3 signaling pathway contributes to the initiation and maintenance of intestinal inflammation and may also play a role in the development of intestinal fibrosis.⁵ Anti-TL1A monoclonal antibodies have demonstrated robust efficacy in clinical trials for IBD. This dual-target approach is designed to achieve a synergy in anti-inflammatory activity and explore the potential to modulate pathways associated with intestinal fibrosis. The anti-TL1A antibody in BA2201 is generated using BA-huMab®, Boan Biotech's proprietary human antibody transgenic mouse platform. It recognizes a unique epitope and has potent blocking activity. BA2201 also features a novel bispecific format and Fc engineering for prolonged half-life extension, with the aim of lowering risk for drug immunogenicity, extending dosing intervals, and enabling the development of subcutaneous formulations.
Preclinical studies showed that BA2201 effectively blocked the interaction between TL1A and DR3, while its IL-23-binding arm maintained the potent inhibition of IL-23 signaling. In a colitis model, BA2201 showed strong anti-inflammatory activity and outperformed the monoclonal antibodies each targeting TL1A or IL-23 alone. Additional preclinical assessments indicated that BA2201 has a low immunogenicity risk and favorable drug tolerability. It exhibited a prolonged half-life in cynomolgus monkeys which supports its potential for administration dosing once every three months in humans. BA2201 is also formulated at a high concentration with good stability to facilitate subcutaneous administration.

Jiang Hua, Chairlady and Chief Executive Officer of Boan Biotech, said:"The acceptance of the IND application marks a major milestone in advancing our innovative autoimmune pipeline. By targeting both IL-23 (p19) and TL1A, BA2201 is designed to combine potent anti-inflammatory activity with anti-fibrotic potential. It is also engineered to reduce immunogenicity risk while supporting extended dosing intervals and convenient subcutaneous administration. These all assist in patients’ long-term management of IBD. We will accelerate the clinical development of BA2201 to further evaluate its therapeutic potential, with the aim of providing patients with a better treatment option.”

References：
1.Yang C, Chen P. Analysis of global trends and current status of diagnosis and treatment of inflammatory bowel disease. Journal of Diagnostics Concepts & Practice. 2025;24(4):373-382. doi:10.16150/j.1671-2870.2025.04.003.
2.Atreya R, Neurath MF. Biomarkers for Personalizing IBD Therapy: The Quest Continues. Clin Gastroenterol Hepatol. 2024;22(7):1353-1364. doi:10.1016/j.cgh.2024.01.026.
3.Plevris N, Lees CW. Disease Monitoring in Inflammatory Bowel Disease: Evolving Principles and Possibilities. Gastroenterology. 2022;162(5):1456-1475.e1. doi:10.1053/j.gastro.2022.01.024
4.Yang W, Yu T, Cong Y. Stromal Cell Regulation of Intestinal Inflammatory Fibrosis. Cell Mol Gastroenterol Hepatol. 2024;17(5):703-711. doi:10.1016/j.jcmgh.2024.01.007.
5.Bamias G, Menghini P, Pizarro TT, Cominelli F. Targeting TL1A and DR3: the new frontier of anti-cytokine therapy in IBD. Gut. 2025;74(4):652-668. doi:10.1136/gutjnl-2024-332504.