BOAN BIOTECH (06955): BA2201 (TL1A/IL-23) Approved to Initiate Clinical Trial in China, Intended for the Treatment of Inflammatory Bowel Disease

BOAN BIOTECH (06955) announced that BA2201, a Class 1 innovative drug independently developed by the company, has been approved by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) to initiate clinical trials. The investigational drug is a long-acting bispecific antibody targeting TL1A and IL-23 (p19), intended for the treatment of inflammatory bowel disease ("IBD") and other autoimmune diseases. IBD is a group of chronic, relapsing, non-specific intestinal inflammatory diseases, mainly including ulcerative colitis (UC) and Crohn's disease (CD). Data show that there are approximately 4.9 million IBD patients worldwide, with China having the highest number of patients globally, and the prevalence rate is rising rapidly. The long-term management of this disease continues to face significant challenges: despite the continuous development of targeted therapies, about one-third of patients do not respond to initial treatment, and about half of patients lose response over time. In addition, persistent inflammation continuously accumulates damage to the intestine and triggers complications, and is also associated with the development of intestinal fibrosis. In response to these clinical needs, BA2201 simultaneously targets two core pathogenic pathways of IBD: IL-23 (p19) and TL1A. Among them, IL-23 (p19) is a clinically validated IBD therapeutic target; the TL1A and its receptor DR3 pathway is involved in both inflammatory responses and intestinal fibrosis-related processes, and anti-TL1A monoclonal antibodies have demonstrated excellent efficacy in IBD clinical trials. This dual-target design aims to exert synergistic anti-inflammatory effects and explore the potential to intervene in intestinal fibrosis-related mechanisms. With its unique molecular structure, BA2201 exerts significant anti-inflammatory and anti-fibrotic efficacy while also reducing the risk of immunogenicity, and has the potential to achieve subcutaneous administration once every 3 months in humans, forming differentiated advantages in terms of efficacy and long-term dosing convenience. In terms of molecular design, BA2201 adopts a novel "1+1" asymmetric bispecific antibody structure. Among them, the TL1A-binding arm is derived from the company's independently developed fully human antibody transgenic mouse platform BA-huMab, featuring a unique binding epitope and highly efficient blocking activity; its IL-23-binding arm also exhibits highly efficient pathway inhibitory activity. At the same time, BA2201, through monovalent binding to TL1A and Fc silencing design, reduces Fc receptor-mediated binding and lowers the risk of immunogenicity; the long-acting Fc engineering of BA2201, combined with the development of a high-concentration subcutaneous formulation, is expected to support longer dosing intervals and more convenient administration, enhancing long-term treatment convenience. The therapeutic potential of BA2201 has been preliminarily validated in animal models. In a mouse colitis model, BA2201 showed excellent anti-inflammatory effects, with superior efficacy compared to anti-TL1A monoclonal antibodies or anti-IL-23 monoclonal antibodies. Preclinical evaluation also suggests that BA2201 has a low risk of immunogenicity and good tolerability; it exhibits a long half-life in cynomolgus monkeys, supporting the long-acting dosing design. The clinical trial approved this time is a randomized, double-blind, placebo-controlled, multicenter Phase I/IIa clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of subcutaneous injection of BA2201 injection in healthy participants and patients with moderately to severely active ulcerative colitis, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity characteristics of subcutaneous injection of BA2201 injection, as well as the preliminary efficacy in patients with moderately to severely active ulcerative colitis who have failed or are intolerant to standard treatment. As BA2201 enters the clinical stage, the company will accelerate subsequent research and expedite the validation of this therapeutic approach that combines dual-target intervention with long-term dosing convenience. In addition to BA2201, the company has also laid out multiple bispecific and multispecific antibody candidates in the field of autoimmune disease treatment, and will steadily advance the development and clinical translation of related projects, with the aim of providing more innovative treatment options for patients in this disease area.