Henlius Biotech (02696) rose over 4% intraday, trading at HK$54.35 with turnover reaching HK$14.58 million. The biopharmaceutical firm announced completion of the first US patient dosing in its global Phase 3 clinical trial for HLX22 (recombinant humanized anti-HER2 monoclonal antibody injection). This multicenter study evaluates HLX22 combined with trastuzumab and chemotherapy (XELOX) versus trastuzumab plus XELOX with or without pembrolizumab as first-line treatment for HER2-positive locally advanced or metastatic gastroesophageal junction and gastric cancer.

Parallel patient recruitment is underway across mainland China, Australia, and Japan. HLX22 represents an innovative HER2-targeted monoclonal antibody licensed and subsequently developed by Henlius, with potential applications in solid tumors including gastric and breast cancers. Notably, the therapy received orphan drug designation from both the US Food and Drug Administration (FDA) in March 2025 and the European Commission (EC) in May 2025 for gastric cancer treatment.