HLX11

HLX11 is a monoclonal antibody developed by Shanghai Henlius Biotech. Its target is HER2 (the sponsor names HER2). The sponsor states: A recombinant anti-HER2 domain II humanised monoclonal antibody developed as a biosimilar to pertuzumab (EU-Perjeta), given with trastuzumab and docetaxel in neoadjuvant HER2-positive breast cancer. ClinicalTrials.gov describes the intervention as: Neoadjuvant(q3w/cycle，total 4cycle): HLX11(loading dose of 840 mg IV, followed by 420 mg IV q3w)+trastuzumab(loading dose of 8 mg/kg IV, followed by 6mg/kg IV q3w)+docetaxel(75mg/m2 IV q3w) Adjuvant: doxorubicin( 60 mg/m2 IV q3w)+cyclophos. It is the investigational product in 1 recruiting or active industry-led phase 2 and phase 3 interventional cancer trial, including the phase 3 study NCT05346224 (A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer), in HR-positive / HER2-negative breast cancer and HER2-positive breast cancer. The largest, NCT05346224, plans to enrol 900 participants with primary completion expected 2024-05-15. Status reflects the highest phase registered on ClinicalTrials.gov at the 2026-09-11 check; no efficacy results are recorded here.