Henlius Biotech (02696) climbed nearly 6% again during trading. At the time of writing, shares rose 5% to HK$57.8, with turnover reaching HK$14.32 million. The company announced significant progress in its clinical pipeline. An international multicenter Phase 3 trial for HLX22, a recombinant humanized anti-HER2 monoclonal antibody injection, has dosed its first patient in the United States. This study evaluates HLX22 combined with trastuzumab and chemotherapy (XELOX) versus trastuzumab and chemotherapy (XELOX) with or without pembrolizumab as first-line treatment for HER2-positive locally advanced or metastatic gastroesophageal junction and gastric cancer. This Phase 3 trial is simultaneously progressing in mainland China, Australia, Japan, and other regions.
Additionally, Henlius achieved a major milestone in the global development of its PD-L1-targeting antibody-drug conjugate (ADC), HLX43 for injection. Regulatory authorities in China (NMPA), the United States (FDA), Australia (TGA), and Japan (PMDA) have granted approval to initiate an international multicenter Phase 2 clinical study for HLX43 targeting advanced non-small cell lung cancer (NSCLC). The first patient in China has already been dosed. Notably, HLX43 represents the world's first PD-L1 ADC to advance into Phase 2 clinical trials, as no similar PD-L1-targeting ADC has been approved globally.