{"entity":{"id":"hlx11","kind":"drug","name":"HLX11","aka":[],"tldr":"HLX11 is an experimental monoclonal antibody from Shanghai Henlius Biotech in phase 3 trials for HR-positive / HER2-negative breast cancer and HER2-positive breast cancer, aimed at HER2.","summary":"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 was scheduled for 2024-05-15 on the registry. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.","status":"phase-3","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of HLX11","url":"https://clinicaltrials.gov/search?intr=HLX11"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","breast-her2-positive"],"sections":[],"technologies":[],"targets":["her2"],"drugs":[],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05346224"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"modality":"monoclonal antibody","mechanism":"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.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/hlx11/","neighbours":{"cancer":[{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"target":[{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"company":[{"id":"henlius","kind":"company","name":"Shanghai Henlius Biotech","route":"/companies/henlius/"}],"trial":[{"id":"nct05346224","kind":"trial","name":"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","route":"/trials/nct05346224/"},{"id":"nct02003209","kind":"trial","name":"Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer","route":"/trials/nct02003209/"}]}}