-Data highlights potential of ZL-1503 as a promising treatment for moderate-to-severe atopic dermatitis and other IL-13 and IL-31-driven diseases

-Favorable preclinical safety profile, prolonged half-life and durable suppression of both inflammatory and pruritogenic pathways support advancement of ZL-1503 to IND-enabling studies

-Zai Lab plans to file an IND for ZL-1503 for moderate-to-severe atopic dermatitis by the end of 2025

SHANGHAI, China & CAMBRIDGE, MA, USA I June 13, 2025 I Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced new data from its preclinical study of ZL-1503, the Company’s promising IL-13/IL-31R bispecific antibody, demonstrating its ability to simultaneously suppress the inflammatory and pruritogenic (itch-causing) pathways in atopic dermatitis (AD). The findings, featured during a poster presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025 in Glasgow, Scotland, highlight the potential of ZL-1503 as a novel treatment option for moderate-to-severe AD.

Medications that inhibit IL-4/IL-13 signaling have markedly improved the therapeutic landscape for AD. Certain AD symptoms are mediated by IL-31; however, they are only partially alleviated by IL-4/IL-13 inhibition. As a result, many patients experience slow and modest clinical responses to currently available medications.

ZL-1503 was evaluated in a pilot preclinical study in non-human primates to assess its long-term effects on IL-31-mediated scratching and IL-13-induced signaling (pSTAT6). Key study results presented at the EAACI Congress 2025 include:

  • An intravenous single dose of ZL-1503 (10 mg/kg, iv) completely inhibited IL-13-mediated pSTAT6 and IL-31-induced scratching for at least 76 days in all preclinical subjects.
  • Two out of three subjects exhibited prolonged IL-13-mediated pSTAT6 inhibition for over 118 days, and one out of three subjects sustained IL-31-induced scratching inhibition for over 133 days.
  • Pharmacokinetic (PK) analysis of serum samples collected during the study revealed that ZL-1503 exhibited slow clearance, correlating closely pharmacodynamic (PD) responses, demonstrating strong PK/PD relationships in blocking IL-13 and IL-31 pathways in the preclinical model.
  • ZL-1503 was well tolerated following weekly IV dosing up to 150 mg/kg.
  • Additionally, in vitro studies showed that binding to one target did not affect ZL-1503’s blocking effects on the other target.

Details regarding the ZL-1503 poster presentation at EAACI Congress 2025 are as follows:

Title: ZL-1503: A Bispecific Antibody Targeting Inflammatory and Pruritogenic Pathways with a Prolonged Serum Half-life and Sustained Activity in Non-human Primates
Presenter: Linda Liu, Ph.D., Senior Vice President, Biologics Discovery, Zai Lab
Session Title: Thematic Poster Session 18 (TPS18), Biologicals 01
Date/Time: Friday, June 13, 2025, from 12:00 – 13:00 BST
Abstract Number and Location: n°000625 & Poster PrefixD1.365, Poster Zone

About Zai Lab

Zai Lab is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health worldwide.

For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.X.com/ZaiLab_Global, www.twitter.com/ZaiLab_Global.

SOURCE: Zai Lab