InnoCare Announce First Subject Dosed in Phase 1 Clinical Trial of ICP-054, a Novel Potentially Best-in-Class Oral IL-17AA/AF Inhibitor

- Phase 1 trial designed to evaluate the safety, tolerability, and pharmacokinetic properties of ICP-054 (ZB021) in healthy volunteers 
- Phase 1 SAD and MAD data expected by year-end 2026

BEIJING, May 13, 2026 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today 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.

Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, “We are committed to developing innovative drugs in the field of autoimmune diseases. We will accelerate the clinical development of the oral IL-17, and we believe that this novel therapy will become a better treatment option for patients with autoimmune diseases.”

About ICP-054 (ZB021)

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.

About InnoCare Pharma

InnoCare (SSE: 688428; HKEX: 09969) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing innovative drugs for the treatment of cancers and autoimmune diseases, two therapeutic areas with unmet medical needs worldwide. InnoCare has established comprehensive innovation platforms for drug discovery. To date, the Company has developed a robust product pipeline comprising three approved drugs (orelabrutinib, tafasitamab and zurletrectinib), more than ten innovative drug candidates in clinical development, and multiple programs in preclinical stages. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. For more information about InnoCare, please visit https://www.innocarepharma.com/en and follow us on LinkedIn.

InnoCare Forward-looking Statements

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