InnoCare Pharma gains Chinese IND approval for dual-target IBD antibody ICP‑B161
ICP-B161 is the company's fifth candidate to enter clinical development in 2026; the release gives no enrollment timetable.
Adrian Kessler
Clinical development can advance after InnoCare Pharma HKG9969 SHA688428 reported Chinese IND approval for its dual-target antibody ICP-B161 in a release distributed Monday.
The company said the Center for Drug Evaluation of China's National Medical Products Administration approved its Investigational New Drug application for autoimmune diseases, including inflammatory bowel disease. ICP-B161 is its fifth novel candidate to enter clinical development in 2026, according to the Oct. 11 release.
InnoCare is a commercial drug developer with several marketed medicines, operations in China and the United States, and a pipeline focused on cancer and autoimmune diseases.
Its Hong Kong shares traded at HK$12.66, below their previous close, as of 10:28:01 a.m. Hong Kong time on Monday, according to the HKG9969 quote page.
The announcement does not specify the trial phase, planned enrollment, comparator or endpoints. It also gives no first-dose date, leaving shareholders without a timetable for the candidate's first clinical evidence.
InnoCare describes ICP-B161 as a long-acting antibody designed to inhibit both TL1A and IL-23p19. It says the design supports subcutaneous administration and less frequent dosing, but the release supplies no human pharmacokinetic measurements or dosing interval.
The supporting efficacy evidence described in the release comes from animal models. Its comparisons with single-target antibodies therefore do not establish a benefit in patients or an advantage over existing IBD therapies. No human safety results were reported.
"We will accelerate the development of ICP-B161 to deliver innovative therapies to IBD patients as soon as possible," InnoCare chief executive Jasmine Cui said in the release.
Other Inflammatory Drugs Have Human Trial Data
TL1A competitor Teva Pharmaceutical Industries Ltd. NYSETEVA reported on Feb. 17 that its investigational antibody duvakitug was in Phase 3 development for ulcerative colitis and Crohn's disease. Its randomized maintenance study enrolled 130 induction responders and tested two active doses over 44 weeks.
The study re-randomized patients between active doses, so that maintenance report supplies a durability reference without a concurrent placebo comparison. InnoCare's animal comparisons cannot rank ICP-B161 against those human results.
The IL-23 pathway is also being tested through different drug formats. Johnson & Johnson NYSEJNJ reported on Oct. 9 week-112 psoriasis results for ICOTYDE, an oral peptide that blocks the IL-23 receptor.
That receptor approach differs from ICP-B161's antibody targeting IL-23p19, and the psoriasis results do not establish efficacy in IBD. The programs illustrate different ways of intervening in inflammatory signalling, with evidence from different diseases and development stages.
Read more: Johnson & Johnson reports at least 72 per cent PASI 90 after two years
Commercial Revenue Supports the Broader Pipeline
InnoCare's Aug. 24 interim results reported revenue of 1.1 billion yuan for the six months ended June 30. Revenue rose 55.5 per cent from a year earlier, and the company reported profit of 239.7 million yuan, while research and development investment reached 497.1 million yuan.
Cash and related accounts stood at approximately 8.4 billion yuan on June 30. The ICP-B161 announcement does not set a cash runway or disclose a budget for the candidate's trial.
The interim update also said soficitinib and fadeucravacitinib, its novel TYK2 inhibitors, met primary endpoints in Phase 3 trials for atopic dermatitis and psoriasis, respectively. ICP-B161 adds a different mechanism to that autoimmune pipeline, with the clinical protocol still undisclosed in its announcement.
Read more: Alumis reports 48-week scalp and itch data from Phase 3 psoriasis program
As checked on Oct. 12, neither the ICP-B161 release nor InnoCare's event calendar provides a future date for this program. A trial registration or first-dose announcement would establish the next clinical checkpoint.
