HLX22

HLX22 is a monoclonal antibody developed by Shanghai Henlius Biotech. Its target is HER2 (the sponsor names HER2). The sponsor states: HLX22 is a recombinant humanised anti-HER2 monoclonal antibody injection, given at 15 mg/kg every three weeks in combination with trastuzumab and chemotherapy (XELOX) in HER2-positive gastric or gastroesophageal junction adenocarcinoma. It is the investigational product in 2 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, including the phase 3 study NCT06532006 (A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer), in gastric & gastro-oesophageal junction cancer and HR-positive / HER2-negative breast cancer. The largest, NCT06532006, plans to enrol 550 participants with primary completion expected 2027-06-01. Status reflects the highest phase registered on ClinicalTrials.gov at the 2026-09-11 check; no efficacy results are recorded here.