BOAN BIOTECH (06955.HK): BA2201 cleared to enter IBD clinical trial

NewTimeSpace News: On 6 November 2026, Shandong Boan Biotechnology Co., Ltd. (06955.HK) announced voluntarily that its self-developed Class 1 innovative drug BA2201 has been approved by the Center for Drug Evaluation of the National Medical Products Administration to commence clinical trials. The drug candidate 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 inflammatory bowel diseases, mainly including ulcerative colitis and Crohn's disease. Data show that there are about 4.9 million IBD patients worldwide, with China having the largest number of patients globally and a rapidly rising prevalence. Despite advances in targeted therapies, about one-third of patients fail to respond to initial treatment and about half lose response over time.

BA2201 adopts a novel "1+1" asymmetric bispecific structure, simultaneously targeting the IL-23 (p19) and TL1A pathways, aiming to exert synergistic anti-inflammatory effects and explore the potential to intervene in intestinal fibrosis, with the potential for subcutaneous injection once every three months. The trial approved this time is a randomised, double-blind, placebo-controlled, multi-center Phase I/IIa study evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of subcutaneous BA2201 injection in healthy participants and patients with moderate-to-severe active ulcerative colitis.