For patients living with inflammatory bowel disease (IBD), persistent symptoms, repeated treatment failures and the need for lifelong therapy remain major challenges. InnoCare is developing ICP-B161, a bispecific antibody designed to block two inflammatory pathways simultaneously, with the aim of improving treatment outcomes and reducing the burden of long-term care. Following regulatory clearance in China and the start of dosing in healthy volunteers, BioPharma Boardroom speaks with Dr. Jason Zhang, VP of Pharmacology and Translational Medicine at InnoCare Pharma, about the science behind ICP-B161, its preclinical findings, potential benefits for patients and the company's plans to explore its use in IBD and other autoimmune diseases.

Q. What led InnoCare to target both TL1A and IL-23p19 in a single antibody, and what advantages could this approach offer over existing treatments for inflammatory bowel disease?

Inflammatory bowel disease (IBD) encompasses a group of complex, chronic inflammatory disorders whose onset and progression involve multiple immune regulatory pathways. Among the targets that have attracted considerable attention, TL1A and IL-23p19 have each demonstrated clinical therapeutic value.

TL1A acts through engagement of its receptor DR3 to participate in immune cell activation and inflammatory responses, and has also been implicated in tissue remodeling and fibrosis. This pathway further promotes the activation of Th1 and Th17 cells as well as the production of a broad array of pro-inflammatory cytokines.

IL-23 contributes to the maintenance of pathogenic Th17 responses, drives the production of pro-inflammatory cytokines such as IL-17, and plays a role in the initiation and persistence of chronic intestinal mucosal inflammation.

Accordingly, simultaneous targeting of TL1A and IL-23p19 offers the potential to intervene from distinct yet interconnected disease-driving pathways, yielding complementary mechanisms of action and the prospect of more comprehensive and deeper disease control.

Current IBD biologics generally target one major pathway, such as TNF, IL-23, integrins, or TL1A. A TL1A/IL-23p19 antibody could address two clinically validated inflammatory axes in a single treatment, with the potential to achieve more comprehensive inflammatory control. Preclinical results have also shown greater inhibition disease activity and inflammatory cytokine release than either monotherapy in several experimental model.

Q. Preclinical studies showed that ICP-B161 performed better than the corresponding single-target antibodies and other bispecific antibodies in a mouse model of colitis. What do these findings suggest about its potential in patients with IBD?

Improvement in the mouse model of colitis (disease activity index) suggests that the dual-target antibody may achieve stronger control of intestinal inflammation and could potentially increase the proportion of patients reaching clinical remission in IBD.

Monkey pharmacokinetic studies showed that ICP-B161 has a steady-state half-life of over 50 days, supporting the potential for less frequent dosing and informing future clinical dosing strategies.

Current preclinical data support the further development of ICP-B161. As the program progresses into clinical development, we will continue to assess its safety, PK profile, and preliminary efficacy, further establishing its therapeutic potential and differentiation.

Q. ICP-B161 has been designed for longer-lasting activity, less frequent dosing and subcutaneous administration. How important could these features be for patients managing a lifelong condition such as IBD?

Managing a lifelong condition like IBD makes treatment convenience and delivery methods significant priorities for patients. Less frequent dosing could reduce treatment burden, travel, appointment time, and the number of opportunities to miss a dose. Subcutaneous administration could give patients more flexibility by allowing treatment at home and reducing infusion-center visits.

Q. With several new therapies emerging for IBD, where do you see the biggest gaps in treatment today, and which patient groups could benefit most from a dual-target approach?

The biggest gaps in IBD treatment today are the therapeutic efficacy ceiling, persistent primary nonresponse or secondary loss of efficacy, and limited options for patients whose disease remains active after failing second-line or multiple advanced therapies. Simultaneously targeting complementary inflammatory pathways such as TL1A and IL-23p19 may help overcome the efficacy ceiling and could be valuable for patients with medically refractory disease.

Q. ICP-B161 is InnoCare’s fifth novel drug candidate to enter clinical development in 2026. What does this progress say about the company’s research priorities and the role of its large molecule platform in expanding the autoimmune disease pipeline?

InnoCare’s R&D strategy is modality-agnostic, focusing on deploying the most appropriate technologies to address disease biology and unmet medical needs. Its capabilities span differentiated small molecules targeting BTK, BCL2, and TYK2; antibody and bispecific antibody therapies targeting cytokine pathways and immune regulation; ADCs for precision tumor killing; and emerging modalities such as protein degraders and molecular glues for challenging targets. This also reflects our sustained commitment to platform innovation and our ability to continuously build and advance cutting-edge technology platforms.

ICP-B161, InnoCare’s fifth novel drug candidate to enter clinical development in 2026, demonstrates how its large molecule platform supports the design of differentiated biologics, combining TL1A and IL-23p19 dual targeting with extended half-life, less frequent dosing, and subcutaneous administration. Together with our expanding clinical pipelines and global research collaborations, the progress reflects InnoCare’s strategy of using platform-based innovation to broaden its autoimmune and oncology portfolios.

Q. Following IND approval in China, what are the next steps for ICP-B161’s clinical development, and how do you see its potential extending beyond IBD into other autoimmune diseases?

ICP-161 has reached the milestone of first-patient dosing in healthy volunteers. Based on the mechanism of action of ICP-B161, Rheumatoid arthritis (RA), psoriatic arthritis (PsA) and Axial spondyloarthritis (axSpA), etc., could all be potential indications to explore.