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Henlius doses first US patient in gastric cancer study

July 14, 2025 at 09:24 AM UTC•By FilingReader AI

Shanghai Henlius Biotech announced dosing of the first US patient in its global Phase 3 study of HLX22 for HER2-positive gastric and gastroesophageal junction cancer.

The trial compares HLX22 with trastuzumab and XELOX chemotherapy versus trastuzumab and XELOX, with or without pembrolizumab. The study is also active in China, Australia, and Japan.

HLX22 has orphan-drug designation from the FDA and European Commission for gastric cancer.

This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com

Primary Source Document

VOLUNTARY ANNOUNCEMENT - FIRST PATIENT IN THE UNITED STATES HAS BEEN DOSED IN AN INTERNATIONAL MULTI-CENTER PHASE 3 CLINICAL STUDY OF HLX22 (RECOMBINANT HUMANIZED ANTI-HER2 MONOCLONAL ANTIBODY INJECTION) IN COMBINATION WITH TRASTUZUMAB AND CHEMOTHERAPY (XELOX) VERSUS TRASTUZUMAB AND CHEMOTHERAPY (XELOX) WITH OR WITHOUT PEMBROLIZUMAB FOR THE FIRST-LINE TREATMENT OF HER2-POSITIVE, LOCALLY ADVANCED OR METASTATIC GASTROESOPHAGEAL JUNCTION AND GASTRIC CANCERJuly 14, 2025 at 09:00 AM UTC

Shanghai Henlius Biotech, Inc

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