공시 • May 14
InnoCare Pharma Announces First Subject Dosed In Phase 1 Clinical Trial of ICP-054 InnoCare Pharma announced that the first subject has been dosed in the Phase 1 trial of ICP-054 (ZB021), a novel potentially best-in-class oral IL-17AA/AF inhibitor. The Phase 1 trial is supported by robust preclinical data demonstrating a desirable pharmacology and toxicology profile. In addition to potent inhibition of IL-17AA/AF signaling, and anti-inflammatory activity demonstrated in preclinical animal models, excellent oral bioavailability was observed across multiple preclinical species, including non-human primates. Together, these data support the potential of ICP-054 to be a differentiated oral therapy for autoimmune and inflammatory diseases associated with dysregulated IL-17 signaling. The Phase 1 study is designed to evaluate the safety, tolerability, and pharmacokinetic profile of single ascending doses (SAD) and multiple ascending doses (MAD) of ICP-054 in healthy volunteers and is being conducted in partnership with Zenas BioPharma in China. These data are expected by year-end 2026. Upon completion of the study, InnoCare plans to advance clinical development of ICP-054 to establish its proof-of-concept in the field of autoimmune diseases. ICP-054 is a novel potentially best-in-class oral small molecule IL-17AA/AF inhibitor being developed by InnoCare in partnership with Zenas BioPharma. ICP-054 is designed to selectively block the signal transduction pathways of both the IL-17AA homodimer and IL-17AF heterodimer, inhibiting downstream pro-inflammatory cytokine and chemokine release. Preclinical studies have demonstrated potent anti-inflammatory activity, a favorable safety profile, and excellent Absorption, Distribution, Metabolism, and Excretion (ADME) properties. The IL-17 pathway has demonstrated broad utility across many rheumatic and dermatologic indications. Currently, no oral IL-17 inhibitors have been approved or are in late-stage development globally. ICP-054's oral, small molecule profile may offer meaningful advantages over currently approved biologic IL-17 therapies in terms of convenience, compliance, and accessibility. Zenas BioPharma licensed the exclusive rights from InnoCare Pharma to develop, manufacture, and commercialize ICP-054 in all fields of use worldwide, excluding greater China and Southeast Asia. 공시 • May 10
InnoCare Pharma Announces Approval Of Phase II Clinical Trial Of TYK2 Inhibitor ICP-488 For Sjögren's Syndrome In China InnoCare Pharma announced the approval of the Investigational New Drug (IND) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct a Phase II clinical trial of its novel TYK2 inhibitor ICP-488 for the treatment of Sjögren's syndrome. ICP-488 is an oral, potent, and selective TYK2 allosteric inhibitor. By binding to the TYK2 JH2 domain, ICP-488 blocks the signal transduction of IL-23, IL-12, type 1 IFN, and other inflammatory cytokines, thereby inhibiting the pathological processes of autoimmune and inflammatory diseases. As Sjögren's syndrome is associated with the aberrant activation of TYK2 pathways, ICP-488 is expected to provide a novel therapeutic option for patients. Sjögren's syndrome is a chronic inflammatory autoimmune disease characterized by lymphoproliferation and progressive exocrine gland injury. Its main clinical manifestations include salivary and lacrimal gland dysfunction, as well as multisystem and multi-organ involvement, which significantly impacts patients’ quality of life. In China, the prevalence of Sjögren's syndrome ranges from 0.33% to 0.77%, with an estimated population of 5 million. Currently, there are no approved targeted therapies for Sjögren's syndrome globally. 공시 • Apr 29
InnoCare Pharma Announces First Patient Dosed In Phase III Trial Of Orelabrutinib For SLE InnoCare Pharma announced that the first patient has been dosed in the registrational Phase III clinical trial of novel BTK inhibitor orelabrutinib for the treatment of systemic lupus erythematosus (SLE). This is a randomized, double-blind, placebo-controlled, multicenter Phase III study evaluating the efficacy and safety of orelabrutinib in patients with SLE, with the SRI-4 response rate at Week 52 as the primary endpoint. The Phase IIb clinical study of orelabrutinib met its primary endpoint, making orelabrutinib the first BTK inhibitor to demonstrate significant efficacy in a Phase II clinical trial for SLE. Under stringent steroid-tapering requirements, orelabrutinib 75 mg once daily (QD) achieved a statistically significant improvement in SLE Response Index-4 (SRI-4) rate compared with placebo at Week 48 (57.1% vs. 34.4%, p < 0.05), meeting the primary endpoint. In a higher disease activity subgroup (BILAG =1A or =2B; SLEDAI-2K score =4), the 75 mg QD group achieved SRI-4 response rate of 68%, representing a 43% absolute improvement over placebo. Notably, 71.1% of patients in the 75 mg group achieved steroid reduction to =7.5 mg, compared with 43.6% in the placebo group. SLE is a systemic autoimmune disease that often leads to multi-organ damage, particularly affecting the kidneys, musculoskeletal system, nervous system, skin, blood, and respiratory systems, with nearly all organ systems potentially involved. According to Frost & Sullivan, there are approximately 8 million people with SLE worldwide. According to the "China SLE Development Report 2020", there are approximately 1 million SLE patients in China, ranking first globally in total number and second in incidence rate. Most SLE patients are young and middle-aged women, requiring long-term management for years or even decades, resulting in huge unmet medical needs. 공시 • Apr 21
InnoCare Pharma Unveils Preclinical Data Of Novel B7-H3 Targeted ADC ICP-B794 InnoCare Pharma presented preclinical data of its novel B7-H3 targeted ADC ICP-B794. The research results were presented in the form of a poster at the AACR Annual Meeting (Abstract Code: LB355). ICP-B794 is a B7-H3 targeted ADC with a novel linker-payload. It demonstrated potent anti-tumor activity in preclinical tumor models and a significantly larger safety window compared to similar drugs. A Phase I dose-escalation clinical trial is undergoing. ICP-B794, derived from the company's proprietary ADC platform, employing an irreversible connector, a highly hydrophilic linker and a novel and potent payload, resulted in significantly enhanced tumor-killing effects and improved stability and safety. ICP-B794 exhibited excellent drug-to-antibody ratio (DAR) value stability and low payload release in human plasma. In the in vitro cellular assays, ICP-B794 demonstrated significantly improved cell killing activity compared to similar drugs. It also demonstrated superior in vivo efficacy to B7H3-ADCs generated from other platforms, achieving therapeutic outcomes even at low dose. ICP-B794 has shown the potential to overcome the drug resistance of other B7-H3 ADCs. In terms of safety evaluation, results of the GLP toxicology study were highly encouraging, with a safety window exceeding 200 folds. 공시 • Mar 30
InnoCare Pharma Limited to Report Q1, 2026 Results on Apr 24, 2026 InnoCare Pharma Limited announced that they will report Q1, 2026 results on Apr 24, 2026 
