InnoCare Begins Phase 1 Dosing of TL1A/IL-23p19 Bispecific ICP-B161 in China

InnoCare Pharma said on October 30, 2026 that the first subject has been dosed in the Phase 1 trial of ICP-B161, a bispecific antibody targeting TL1A and IL-23p19 for autoimmune diseases including inflammatory bowel disease. The Beijing-based company announced the milestone in a GlobeNewswire release.

How ICP-B161 Is Designed to Work

InnoCare is a commercial-stage biopharmaceutical company focused on cancer and autoimmune diseases, with three approved drugs and more than ten clinical-stage candidates. ICP-B161 uses a novel molecular design that extends its half-life, allowing less frequent dosing and supporting subcutaneous administration. By hitting TL1A and IL-23p19 at once, the antibody showed synergistic effects in suppressing cytokine release and reducing inflammatory responses in preclinical work, with the potential to modulate two pathways involved in the pathogenesis and progression of IBD. In preclinical studies it significantly reduced colitis-related symptoms and was well tolerated. No bispecific antibody targeting both TL1A and IL-23p19 has yet been approved anywhere in the world.

Dr. Jasmine Cui, Co-Founder, Chairwoman and CEO, said: "IBD is a progressive, lifelong disease. Despite existing therapies, a large proportion of patients still experience severe complications, and significant unmet medical need remains. We will continue to accelerate the development of ICP-B161 to bring better innovative treatment options to patients with IBD." The release cites an estimated 6.8 million people worldwide living with IBD, a chronic, relapsing inflammatory disorder of the gastrointestinal tract.

InnoCare's Recent Clinical and Licensing Record

According to akta.pro company records, InnoCare reported 2025 annual revenue of RMB 2,375 million (approximately USD 327 million), up 135.3% year-on-year, and a full-year profit of RMB 644 million, its first annual profit. The same records list a cash and related accounts balance of RMB 77.6 billion (approximately USD 10.7 billion) as of Q1 2026. In October 2025 the company out-licensed orelabrutinib autoimmune disease rights plus oral IL-17AA/AF and brain-penetrating TYK2 inhibitors to Zenas BioPharma for US$100 million upfront and over US$2 billion in total deal value, retaining oncology rights globally and autoimmune rights in Greater China and Southeast Asia.

The Path to the ICP-B161 Trial

On October 12, 2026, InnoCare announced that China's NMPA approved its IND for ICP-B161 for autoimmune diseases including IBD, GlobeNewswire reported. On October 13, 2026, the company said the NMPA approved a registrational Phase III trial of mesutoclax with orelabrutinib in relapsed/refractory marginal zone lymphoma, according to GlobeNewswire. On October 28, 2026, TradingView reported that InnoCare presented updated orelabrutinib data at ESMO, showing 89.5% ORR and 95.2% 12-month PFS in MZL, and 93.8% ORR with 50.8-month median PFS in R/R CLL, with no atrial fibrillation observed.

Zenas Collaboration Data Due by End of 2026

Under the Zenas BioPharma partnership for the oral IL-17AA/AF inhibitor ICP-054 (ZB021), both companies are conducting single and multiple ascending dose studies in healthy volunteers in China, with data expected by the end of 2026, according to akta.pro company records.