Henlius (02696) climbed another 5% to HK$57.8 by market close, recording HK$14.32 million in trading volume. The biopharmaceutical firm announced groundbreaking progress across two drug candidates. Its HLX22 anti-HER2 monoclonal antibody achieved first-patient dosing in the U.S. for an international Phase 3 trial targeting HER2-positive gastric cancer. This pivotal study compares HLX22 combined with trastuzumab and XELOX chemotherapy against standard treatments with or without pembrolizumab. Parallel trials are actively recruiting across mainland China, Australia, and Japan.
Concurrently, Henlius's PD-L1-targeting antibody-drug conjugate HLX43 secured clinical trial authorizations from four major regulators: China's NMPA, the U.S. FDA, Australia's TGA, and Japan's PMDA. This clears HLX43 for global Phase 2 development in advanced non-small cell lung cancer, following initial patient dosing in China. As the first PD-L1 ADC worldwide to advance to Phase 2 trials, HLX43 represents a significant breakthrough in the immuno-oncology landscape with no approved competitors in its class.