InnoCare Pharma Limited (HKG: 9969; SHA: 688428), a biopharmaceutical technology company, announced that its independently developed novel bispecific antibody targeting TL1A and IL‑23p19 — ICP‑B161 — has been approved for clinical trials by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of inflammatory bowel disease (IBD) and other autoimmune diseases. This marks the company’s fifth innovative drug cleared for clinical development this year, and no TL1A/IL‑23p19 bispecific antibody has yet been marketed globally.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | CDE, National Medical Products Administration (NMPA), China |
| Action | Clinical trial approval (IND) |
| Product | ICP‑B161 – novel TL1A × IL‑23p19 bispecific antibody |
| Target Indication | Inflammatory bowel disease (IBD) and other autoimmune diseases |
| Announcement Date | 12 Oct 2026 |
| Pipeline Context | Fifth innovative drug of InnoCare approved for clinical trials in 2026 |
| Global Class Status | No TL1A/IL‑23p19 bispecific antibody marketed worldwide |
| Trial Details | Phase, design, and sites not disclosed |
Drug Profile & Mechanism of Action
- Molecule: ICP‑B161, a novel bispecific antibody from InnoCare’s large-molecule (biologics) platform.
- Dual Targets: Specifically binds TL1A (TNF-like ligand 1A) and IL‑23p19 (the p19 subunit of interleukin‑23) — effectively blocking the two core pathways driving IBD onset and progression.
- Synergistic Inhibition: Demonstrates excellent synergistic suppression of cytokine release and inflammatory response through simultaneous dual-pathway blockade.
- Ultra-Long Half-Life: Unique molecular design enables an ultra-long half-life, extending the dosing interval.
- Subcutaneous Delivery: Designed for subcutaneous injection — positioning ICP‑B161 as a differentiated, long-acting bispecific antibody suited to chronic disease management.
Preclinical Evidence
| Finding | Detail |
|---|---|
| Dose Dependency | ICP‑B161 shows dose-dependent activity in animal models, significantly suppressing colitis symptoms |
| TNBS Mouse Colitis Model | At equivalent doses, in vivo potency superior to corresponding TL1A mAb and IL‑23p19 mAb monotherapies and to a same-class bispecific comparator |
| Tolerability | Well tolerated in preclinical studies |
| Data Maturity | Preclinical stage; human safety and efficacy not yet established |
Preclinical studies demonstrated that ICP‑B161 acts in a dose-dependent manner in animal models, significantly inhibiting colitis symptoms. In the TNBS-induced mouse colitis model, at the same administered dose, ICP‑B161’s in vivo pharmacology outperformed the corresponding TL1A monoclonal antibody, IL‑23p19 monoclonal antibody, and a same-class bispecific antibody, with good tolerability.
Disease & Treatment Context – Inflammatory Bowel Disease
- Disease Profile: IBD is a chronic, relapsing inflammatory disease of the intestine that can be a lifelong progressive condition.
- Global Burden: Approximately 6.8 million people are affected worldwide.
- Unmet Need: Per the company, most patients still face severe complications after existing treatments, leaving substantial unmet medical need.
- Pathway Rationale: TL1A and IL‑23 represent two distinct, clinically implicated axes of intestinal inflammation; IL‑23p19 blockade is already validated in immune-mediated disease, while TL1A has emerged as a promising IBD target — dual blockade aims to reach patients inadequately controlled by single-pathway biologics. (Domain background.)
Management Commentary & Market Outlook
- CEO Statement: Dr. Jisong Cui, Co-founder, Chairman and CEO of InnoCare, said: “We are delighted that another innovative drug developed on our large-molecule platform has entered the clinic. IBD is a lifelong progressive disease, and most patients still face severe complications after existing treatments — a huge unmet need. We will accelerate the development of ICP‑B161 to bring a better innovative therapy to IBD patients as early as possible.”
- Platform Validation: ICP‑B161 is the latest clinical-stage asset from InnoCare’s large-molecule platform, extending a company historically anchored in small-molecule (BTK) oncology into autoimmune biologics.
- 2026 IND Momentum: As the fifth innovative drug cleared for clinical trials this year, the approval underscores an accelerated, diversified pipeline build-out.
- First-in-Class Opportunity: With no TL1A/IL‑23p19 bispecific marketed globally, ICP‑B161 competes for first-in-class status in a crowded but rapidly growing IBD biologics landscape.
- Next Steps: Accelerated clinical development of ICP‑B161; trial phase, design, and timelines were not disclosed.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding ICP‑B161, including its clinical development for IBD and other autoimmune diseases, long-acting subcutaneous profile, and potential differentiation versus TL1A and IL‑23p19 monotherapies. Preclinical findings do not guarantee human safety or efficacy. Clinical trial approval permits study initiation but does not assure eventual marketing approval. Actual results may differ due to risks including trial outcomes, competitive dynamics, and regulatory review.-Fineline Info & Tech
