InnoCare Pharma announced that the first participant has been enrolled in the trial for ICP-054, a novel oral IL-17AA/AF inhibitor

– The phase 1 trial aims to evaluate the safety, tolerability, and pharmacokinetic properties of ICP-054 (ZB021) in healthy participants

– Data from the single ascending dose and multiple ascending dose portions of the phase 1 trial are expected to be released by the end of 2026

Beijing, China, May 13, 2026 - Biopharmaceutical high-tech company InnoCare (SSE code: 688428; HKEX code: 09969) today announced the enrollment of the first participant in the Phase 1 clinical trial of ICP-054 (ZB021), a novel oral, potential Best-in-class IL-17AA/AF inhibitor.。

Preclinical data for ICP-054 has demonstrated favorable pharmacological and safety characteristics, strongly supporting the initiation of the Phase 1 clinical trial. In preclinical animal models, ICP-054 effectively inhibits the IL-17AA/AF signaling pathway and exhibits anti-inflammatory activity. Moreover, across various preclinical animal models, including non-human primates, ICP-054 has shown excellent oral bioavailability. Collectively, these data suggest that ICP-054 may offer a new therapeutic option for autoimmune and inflammatory diseases associated with abnormal activation of the IL-17 signaling pathway.

InnoCare and Zenas are collaborating on single ascending dose (SAD) and multiple ascending dose (MAD) studies as part of the Phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetics of ICP-054 in healthy participants. The relevant data is expected to be released by the end of 2026. Upon completion of the study, InnoCare plans to advance clinical development to achieve proof-of-concept in related autoimmune diseases.

Dr. Jisong Cui, Co-founder, Chairman, and CEO of InnoCare, stated, 'We are committed to developing more and better innovative drugs in the field of autoimmune diseases. We will accelerate the clinical development of oral IL-17 therapies, believing this novel treatment will provide improved therapeutic options for patients with autoimmune diseases.'

About ICP-054 (ZB021)

ICP-054 is a novel, orally administered, highly potent and selective IL-17AA/AF inhibitor with significant therapeutic potential in autoimmune and inflammatory diseases. It can efficiently block the signaling of both IL-17AA homodimers and IL-17AF heterodimers, thereby inhibiting the release of pro-inflammatory cytokines and chemokines, exerting anti-inflammatory effects. Additionally, it reduces excessive proliferation of skin keratinocytes and infiltration of inflammatory cells, improving skin lesions, thus suppressing the onset of autoimmune and inflammatory diseases. Preclinical studies have shown that ICP-054 demonstrates robust anti-inflammatory activity and good safety both in vitro and in vivo. In vitro studies reveal its high efficacy and excellent ADME (absorption, distribution, metabolism, and excretion) properties, indicating its potential to provide new treatment options for conditions such as psoriasis, psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa, systemic lupus erythematosus, and other autoimmune and inflammatory diseases linked to abnormal activation of the IL-17 signaling pathway, better meeting patient needs. Currently, there are no approved or late-stage oral IL-17 inhibitors globally. The small-molecule nature of ICP-054 offers potential advantages over currently approved biologic IL-17 therapies in terms of convenience, patient compliance, and clinical accessibility. According to the agreement, InnoCare granted Zenas exclusive rights to develop, manufacture, and commercialize the oral IL-17 AA/AF inhibitor outside Greater China and Southeast Asia.

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