Drugs / HLX11
Trials 2 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04411550 | Jul 2020 → Jul 2021 | — | Shanghai Henlius Biotech | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05346224 | Apr 2022 → May 2024 overdue | HER2 positive breast carcinoma | Shanghai Henlius Biotech | Active not recruiting | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-03-28 | Organon and Co | European Medicines Agency (EMA) Validates Henlius and Organon Filing for Perjeta® (pertuzumab) Biosimilar Candidate HLX11 organon.com ↗ |
| 2024-09-30 | Organon and Co | Primary Endpoint Met in Phase 3 Comparative Clinical Study of Perjeta® (pertuzumab) Biosimilar Candidate HLX11 organon.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HLX11 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05346224 ↗ |
| Modality | Monoclonal antibody | “Pertuzumab is a humanized monoclonal antibody for the treatment of breast cancer. HLX11 is a biosimilar of pertuzumab developed by Shanghai Henlius Biotech, Inc.” PMID 35594017 ↗ May 2022 |
| Route | Intravenous | “a single dose of 420 mg HLX11, US-, EU-, or CN-pertuzumab via intravenous infusion over 60 min” PMID 35594017 ↗ May 2022 |
| Target | ERBB2 | “Recombinant anti-HER2 domain II humanized monoclonal antibody injection” NCT05346224 ↗ |