HENLIUS (02696) announced that the National Medical Products Administration (NMPA) has approved the Phase 2/3 clinical trial applications for HLX22 (a recombinant humanized anti-HER2 monoclonal antibody injection) combined with HLX87 (a HER2-targeted antibody-drug conjugate) in first-line treatment for HER2-positive breast cancer (BC) and HER2-positive breast cancer neoadjuvant therapy (BC neo). The company plans to initiate the clinical studies in China once conditions are met.
HLX22 is a novel HER2-targeted monoclonal antibody licensed and subsequently independently developed by HENLIUS, with potential indications including solid tumors such as gastric cancer and breast cancer. In March and May 2025, HLX22 received Orphan Drug Designation from the U.S. FDA and the European Commission (EC) for gastric cancer treatment.
HLX87 is an innovative HER2-targeted antibody-drug conjugate (ADC) composed of a topoisomerase I inhibitor conjugated to an anti-HER2 monoclonal antibody via a stable cleavable linker. Currently in Phase 3 clinical development, HLX87 is intended for HER2-positive breast cancer treatment. The drug employs a highly membrane-permeable topoisomerase inhibitor as its payload, demonstrating potent bystander-killing effects while minimizing systemic toxicity through a unique and stable linker design, achieving a balance between efficacy and safety.
Preclinical studies have shown that HLX87 exhibits comparable antitumor activity to trastuzumab deruxtecan in multiple tumor xenograft models, with superior safety. Phase 1 clinical data presented at the 2024 American Association for Cancer Research (AACR) Annual Meeting demonstrated favorable tolerability and safety of HLX87 at doses ranging from 2.0 mg/kg to 8.4 mg/kg, along with promising efficacy in patients with breast, gastric, and lung cancers.
A Phase 3 clinical trial of HLX87 for second-line HER2-positive breast cancer treatment is currently underway in China. Previously, HENLIUS entered a strategic collaboration with an external partner for the development of HLX87, with specific terms subject to a formal licensing agreement.