BOAN BIOTECH has announced that its investigational new drug (IND) application for BA2201 has been accepted for review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration. This candidate, independently developed by the company, is a long-acting bispecific antibody targeting both TL1A and IL-23 pathways, designed for the treatment of inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. BA2201 is positioned to become one of the first TL1A/IL-23 bispecific antibodies to enter clinical development in China.

IBD is a chronic, relapsing, non-specific inflammatory condition of the gastrointestinal tract, presenting significant long-term management challenges for patients. Despite advancements in targeted therapies, roughly one-third of patients fail to respond to initial treatment, and approximately half experience loss of response over time. Additionally, persistent inflammation can progressively damage the intestinal lining, trigger complications, and is linked to the development of intestinal fibrosis.

To address these unmet clinical needs, BA2201 is engineered to simultaneously target two core pathogenic pathways: IL-23 (p19) and TL1A. The IL-23 (p19) pathway is a clinically validated target in IBD treatment, while the TL1A/DR3 receptor pathway is involved in both inflammatory responses and processes related to intestinal fibrosis, with TL1A monoclonal antibodies having demonstrated promising efficacy in IBD clinical trials. This dual-target design aims to achieve synergistic anti-inflammatory effects while also exploring the potential to intervene in fibrosis-related mechanisms.

The TL1A antibody sequence of BA2201 originates from the company's proprietary fully human antibody transgenic mouse platform, BA-huMab®, featuring a unique binding epitope and strong blocking activity. In terms of molecular design, BA2201 utilizes a novel bispecific antibody structure and long-acting Fc engineering modifications, which help reduce immunogenicity, extend dosing intervals, and support the development of a subcutaneous injection formulation. Preclinical studies indicate that BA2201 effectively blocks TL1A binding to DR3, while its IL-23 binding domain maintains potent pathway inhibitory activity.

In the colitis models employed, BA2201 demonstrated superior anti-inflammatory efficacy compared to either a TL1A monoclonal antibody or an IL-23 monoclonal antibody alone, showing significantly better therapeutic outcomes. Further preclinical evaluations suggest that BA2201 carries a low immunogenicity risk and exhibits good tolerability. It also displays a prolonged half-life in cynomolgus monkeys, supporting the long-acting dosing design, with expectations of administration once every three months in humans. Additionally, the high-concentration subcutaneous formulation of BA2201 demonstrates good stability, offering convenience for clinical use.

The company believes that the acceptance of this IND application marks a significant milestone in advancing its innovative pipeline in the autoimmune disease space. BA2201, with its synergistic design targeting both IL-23 (p19) and TL1A pathways, aims to deliver dual therapeutic potential combining potent anti-inflammatory and anti-fibrotic effects, while also striving to minimize immunogenicity risks, extend dosing intervals, and enhance administration convenience to better address the long-term disease management needs of IBD patients. The company will accelerate clinical research to further validate the therapeutic value of BA2201, with the goal of bringing improved treatment options to patients suffering from IBD.