# HLX11

Source: https://onco.cc/drugs/hlx11/  
OnCo record `hlx11` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-11
- Tags: pipeline; ctgov-ingest
- 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.

## Sources

- ClinicalTrials.gov: trials of HLX11: https://clinicaltrials.gov/search?intr=HLX11

## Connected records

- cancers: [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- targets: [HER2](https://onco.cc/targets/her2/)
- companies: [Shanghai Henlius Biotech](https://onco.cc/companies/henlius/)
- trials: [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](https://onco.cc/trials/nct05346224/), [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](https://onco.cc/trials/nct02003209/)

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