HENLIUS (02696) shares climbed 4.79% during morning trading, reaching HK$54.65 with a turnover of HK$16.7352 million.

The company announced completion of the first U.S. patient dosing in a global Phase 3 clinical trial evaluating HLX22 (recombinant humanized anti-HER2 monoclonal antibody injection). This multinational study compares HLX22 combined with trastuzumab and chemotherapy (XELOX) against trastuzumab and chemotherapy (XELOX) with or without pembrolizumab as first-line therapy for HER2-positive locally advanced or metastatic gastroesophageal junction and gastric cancer. Concurrent trial activities are underway across mainland China, Australia, Japan, and other regions.

HLX22 represents a novel HER2-targeted monoclonal antibody initially licensed and subsequently developed internally by HENLIUS. Its potential applications target solid tumors including gastric and breast cancers. Notably, HLX22 secured Orphan Drug Designation from the U.S. FDA in March 2025 for gastric cancer treatment, followed by European Commission (EC) approval in May 2025.