Boan Biotech Receives IND Clearance in China for BA2201, a Novel TL1A/IL-23 Bispecific Antibody for Inflammatory Bowel Disease

Yantai, China, November 6, 2026 – Boan Biotech announced today that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has cleared the Investigational New Drug (IND) application for BA2201, a Class 1 innovative drug developed by the company. BA2201 is a long-acting bispecific antibody targeting TL1A and IL-23 (p19) and is intended for the treatment of inflammatory bowel disease (IBD) and other autoimmune diseases.

IBD is a group of chronic, relapsing, and non-specific inflammatory disorders of the intestinal tract, including ulcerative colitis (UC) and Crohn’s disease (CD). ¹  Data show that approximately 4.9 million people worldwide are living with IBD, with China accounting for the largest number of cases and experiencing a rapid rise in prevalence. ² Long-term disease management remains a major challenge. Despite advances in targeted therapies, approximately one-third of patients do not respond to initial treatment, and about half lose response over time. ³ In addition, persistent inflammation can lead to progressive bowel damage and complications, and is also associated with intestinal fibrosis.^4,5

To address these clinical needs, BA2201 targets both IL-23 (p19) and TL1A, two key pathways involved in IBD pathogenesis. IL-23 (p19) is a clinically validated therapeutic target for IBD. The TL1A/DR3 pathway is involved in both inflammatory responses and processes related to intestinal fibrosis, and anti-TL1A monoclonal antibodies have demonstrated robust efficacy in clinical trials for IBD.⁶ This dual-target approach is designed to deliver synergistic anti-inflammatory activity and explore the potential to modulate pathways associated with intestinal fibrosis.

With its unique molecular structure, BA2201 has demonstrated potent anti-inflammatory and anti-fibrotic activity while reducing the immunogenicity risk. It also has the potential to support once-quarterly (Q3M) subcutaneous dosing in humans. Together, these features could offer advantages in efficacy, safety and convenience for long-term treatment.

BA2201 features a novel asymmetric “1+1” bispecific format. Its TL1A-binding arm is derived from BA-huMab®, Boan Biotech’s proprietary fully human antibody transgenic mouse platform. This arm recognizes a distinct epitope and has potent blocking activity. Its IL-23-binding arm also potently inhibits IL-23 signaling. BA2201 combines monovalent TL1A binding with an Fc silencing design to reduce Fc receptor-mediated binding and lower immunogenicity risk. Its half-life-extending Fc mutations, combined with the development of a high-concentration subcutaneous formulation, could support longer dosing intervals and more convenient administration for long-term treatment.

Studies in animal models have provided preliminary support for BA2201’s therapeutic potential. In a mouse colitis model, BA2201 showed strong anti-inflammatory activity, with efficacy superior to monoclonal antibodies targeting either TL1A or IL-23 alone. Additional preclinical assessments suggested a low immunogenicity risk and favorable tolerability. It exhibited a long half-life in cynomolgus monkeys, supporting its long-acting design.

The approved clinical trial is a randomized, double-blind, placebo-controlled, multicenter Phase I/IIa study in healthy participants and patients with moderately to severely active UC. The study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of subcutaneously administered BA2201, as well as its preliminary efficacy in these patients who have failed or are intolerant of standard therapy. With BA2201 entering clinical development, Boan Biotech will accelerate subsequent studies to validate this therapeutic approach, which combines dual-target intervention with long-term dosing convenience. In addition to BA2201, the company has built a portfolio of bispecific and multispecific antibody candidates for autoimmune diseases, and will advance these programs through clinical development, with the aim of bringing more innovative treatment options to patients with these diseases.

References:
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