According to Zhitong Finance App, Boan Biotech (06955) announced that BA2201, a Class 1 innovative drug independently developed by the company, has been approved by the China National Drug Administration (NMPA) Drug Evaluation Center (CDE) to conduct clinical trials. The drug under development is a long-acting bispecific antibody targeting TL1A and IL-23 (p19), and is intended to treat autoimmune diseases such as inflammatory bowel disease (“IBD”).
IBD is a group of chronic, recurrent, nonspecific intestinal inflammatory diseases, which mainly include ulcerative colitis (UC) and Crohn's disease (CD). According to the data, there are about 4.9 million IBD patients in the world. Among them, China has the highest number of patients in the world, and the prevalence rate is rising rapidly. Long-term management of these diseases continues to face major challenges: despite the continuous development of targeted treatments, about one-third of patients do not respond to initial treatment, and about half fail to respond over time. Furthermore, persistent inflammation can continuously accumulate damage to the intestines and cause complications, and is also related to the occurrence of intestinal fibrosis.
In response to the above clinical needs, BA2201 simultaneously targets IL-23 (p19) and TL1A, the two core IBD pathogenesis pathways. Among them, IL-23 (p19) is a clinically proven IBD treatment target; TL1A and its receptor DR3 pathway also participate in inflammatory responses and intestinal fibrosis-related processes, and TL1A monoclonal antibody has shown excellent efficacy in IBD clinical trials. This dual-target design aims to exert synergistic anti-inflammatory effects and explore the potential to interfere with mechanisms related to intestinal fibrosis.
With its unique molecular structure, BA2201 exerts significant anti-inflammatory and anti-fibrotic effects, while also reducing immunogenicity risk, and has the potential to be injected subcutaneously every 3 months in humans, forming a differentiated advantage in terms of efficacy and convenience of long-term administration.
In molecular design, BA2201 uses a novel “1+1" asymmetric double antibody structure. Among them, the TL1a binding arm originated from Ba-humAB®, an all-human antibody-transgenic mouse platform independently developed by the company, and has unique binding epitopes and efficient blocking activity; its IL-23 binding arm also showed efficient pathway inhibitory activity. At the same time, Ba2201 reduces Fc receptor-mediated binding and immunogenic risk through univalent combination with TL1a and Fc silencing design; Ba2201's long-term Fc modification, combined with the development of high-concentration subcutaneous formulations, is expected to support longer dosing intervals and more convenient administration methods, and enhance the convenience of long-term treatment.
The therapeutic potential of BA2201 has been initially validated in animal models. In mouse colitis models, BA2201 showed excellent anti-inflammatory effects, and was superior to TL1A monoclonal antibody or IL-23 monoclonal antibody. Pre-clinical evaluations also suggest that BA2201 has a lower immunogenic risk and is well tolerated; it shows a long half-life in crab-eating monkeys, which supports long-term administration design.
The approved clinical trial is a randomized, double-blind, placebo-controlled, multicenter phase I/IIa clinical study evaluating the safety, tolerability, pharmacokinetics and initial efficacy of BA2201 injection in healthy participants and patients with moderate to severe active ulcerative colitis. It aims to evaluate the safety, tolerability, pharmacokinetics, pharmacokinetics, pharmacodynamics and immunogenicity characteristics of subcutaneous BA2201 injection in patients with moderate to severe active ulcerative colitis who have failed or were intolerant to standard treatment Effective. As BA2201 enters the clinical phase, the company will accelerate follow-up research and speed up the verification of this treatment plan that combines dual-target intervention with the convenience of long-term administration. In addition to BA2201, the company also lays out various dual-antibody and multi-antibody drug candidates around the field of autoimmune disease treatment. The company will steadily advance the development and clinical transformation of related projects to provide patients with more innovative treatment options in this field.