Shandong Boan Biotechnology Co., Ltd. (Boan Biotech) announced that China’s Center for Drug Evaluation (CDE) under the National Medical Products Administration has accepted the Investigational New Drug (IND) application for BA2201, a long-acting bispecific antibody simultaneously targeting TL1A and IL-23 for inflammatory bowel disease (IBD).
BA2201 is positioned as one of the first bispecific antibodies against TL1A and IL-23 to enter clinical trials in China, addressing Crohn’s disease and ulcerative colitis—chronic conditions where roughly one-third of patients fail initial biologic therapy and about half lose responsiveness over time.
Scientific Rationale • Dual targeting: IL-23 (p19) is a clinically validated IBD target, while TL1A and its receptor DR3 are implicated in inflammation and intestinal fibrosis. • Synergy goal: Combining the two mechanisms aims to amplify anti-inflammatory efficacy and potentially curb fibrosis progression. • Proprietary platform: The TL1A arm was generated via Boan Biotech’s BA-huMab® human antibody transgenic mouse system, delivering a unique binding epitope and strong blocking activity. • Molecular engineering: Fc modification is designed to extend half-life, reduce immunogenicity, and enable infrequent subcutaneous dosing.
Preclinical Highlights • Demonstrated complete blockade of TL1A-DR3 interaction and potent inhibition of IL-23 signaling. • In colitis models, BA2201 outperformed single-target TL1A or IL-23 monoclonal antibodies in reducing inflammation. • Exhibited low immunogenicity risk and favorable tolerability in preclinical studies. • Achieved prolonged half-life in cynomolgus monkeys, supporting a potential once-every-three-months dosing regimen. • High-concentration subcutaneous formulation showed stable physicochemical properties, facilitating patient-friendly administration.
Strategic Impact The IND acceptance marks a key milestone in Boan Biotech’s autoimmune pipeline. The company intends to expedite clinical development to validate BA2201’s therapeutic profile and provide an alternative option for patients facing limited long-term efficacy with existing IBD treatments.