InnoCare Pharma (09969): The Phase I clinical trial of ICP-054 (ZB021) has completed the enrollment of the first subject.

InnoCare Pharma (09969) announced that the phase 1 clinical trial of the novel oral, potentially best-in-class IL-17AA/AF inhibitor ICP-054 (ZB021) has completed the first subject enrollment. ICP-054 is a novel oral highly efficient, highly selective IL-17AA/AF inhibitor with significant therapeutic potential in the field of autoimmune and inflammatory diseases. It efficiently blocks the signaling of IL-17AA homodimer and IL-17AF heterodimer, thereby inhibiting the release of pro-inflammatory cytokines and chemokines, exerting anti-inflammatory effects, and reducing overproliferation of skin keratinocytes and inflammatory cell infiltration, improving skin lesions, thus inhibiting the occurrence of autoimmune and inflammatory diseases. Preclinical studies have shown that ICP-054 exhibits strong anti-inflammatory activity and good safety in vitro and in vivo, demonstrating high efficacy and excellent ADME (absorption, distribution, metabolism, and excretion) characteristics in vitro studies. The IL-17 signaling pathway has shown wide application value in various rheumatic and dermatological indications. Currently, there are no approved oral IL-17 inhibitors globally or in late-stage development. The oral small molecule characteristics of ICP-054 have the potential to be more advantageous in terms of ease of administration, patient compliance, and clinical accessibility compared to currently approved biologic IL-17 therapies. The preclinical data of ICP-054 demonstrate good pharmacological and safety characteristics, which can strongly support the conduct of phase 1 clinical trials. In preclinical animal models, ICP-054 effectively inhibits the IL 17AA/AF signaling pathway and demonstrates anti-inflammatory activity. In addition, in various preclinical animal models (including non-human primates), ICP-054 exhibits excellent oral bioavailability. All of these data indicate that ICP-054 could offer a new therapeutic option for autoimmune and inflammatory diseases related to aberrant activation of the IL-17 signaling pathway. In October 2025, the Company's wholly-owned subsidiary, InnoCare Pharma Inc. (InnoCare), registered and established in the United States, granted Zenas BioPharma, Inc. (Zenas; NASDAQ code: ZBIO), exclusive license to develop, manufacture, and commercialize ICP-054 (ZB021) in all regions outside of Greater China and Southeast Asia. The phase 1 trial's Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) aim to evaluate the safety, tolerability, and pharmacokinetics of ICP-054 (ZB021) in healthy volunteers and will be conducted in partnership with Zenas in China. Upon completion of this study, the Company plans to advance the clinical development of ICP-054 (ZB021) to establish its proof of concept in the field of autoimmune diseases.