BOAN BIOTECH (06955.HK): IND application for BA2201 (TL1A/IL-23) accepted by CDE
NewTimeSpace News: On 26 August 2026, Shandong Boan Biotechnology Co., Ltd. (stock code: 06955) announced that the investigational new drug (IND) application for BA2201 has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China. The drug candidate, a long-acting bispecific antibody targeting TL1A and IL-23 independently developed by the Company, is intended for the treatment of inflammatory bowel disease (IBD) including Crohn's disease and ulcerative colitis, and is expected to become one of the first TL1A/IL-23 bispecific antibodies to enter the clinical stage in China.
The announcement stated that IBD is a chronic, relapsing, non-specific intestinal inflammatory disease, with approximately one-third of patients showing no response to initial treatment and approximately half of patients experiencing loss of response over time. BA2201 simultaneously targets two core pathogenic pathways, IL-23 (p19) and TL1A, with its TL1A antibody sequence derived from the Company's proprietary fully human antibody transgenic mouse platform BA-huMab, adopting a novel bispecific antibody structural design and long-acting Fc engineering to help reduce immunogenicity, extend the dosing interval and facilitate the development of a subcutaneous injection formulation. Preclinical studies showed that BA2201 efficiently blocks the binding of TL1A to DR3, maintains strong pathway inhibitory activity at its IL-23 binding end, and demonstrated significantly superior efficacy compared with TL1A monotherapy or IL-23 monotherapy in colitis models; it has a low immunogenicity risk and good tolerability, exhibits a long half-life in cynomolgus monkeys, supporting long-acting dosing with an expected dosing interval of once every three months in humans.
The Company believes that the acceptance of the IND application represents an important step in advancing its innovative pipeline in the autoimmune disease area; BA2201 is synergistically designed based on the IL-23 (p19) and TL1A pathways, aiming to realize the dual therapeutic potential of "potent anti-inflammatory" and "anti-fibrotic" effects, and the Company will accelerate clinical research to further validate its therapeutic value.
NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.
