Drugs / HLX05
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06980454 | Jun → Dec 2025 overdue | colorectal cancer | Shanghai Henlius Biotech | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06309043 | Apr 2024 → Jun 2026 overdue | — | Shanghai Henlius Biotech | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2026-04-14 | Shanghai Henlius Biotech | Regulatory NMPA Grants IND Approval for Henlius' Cetuximab Biosimilar HLX05-N henlius.com ↗
Henlius (2696.HK) announced that the Investigational New Drug (IND) application for its self-developed cetuximab biosimilar HLX05-N (recombinant anti-EGFR human-mouse chimeric monoclonal antibody injection) has been approved by the National Medical Products Administration (NMPA) for the treatment of metastatic colorectal cancer (mCRC). |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-08 | Shanghai Henlius Biotech | First Patient Dosed in China for Phase 1 Clinical Trial of Henlius’ Cetuximab Biosimilar HLX05-N henlius.com ↗ |
| 2026-05-10 | Shanghai Henlius Biotech | Globalisation 2.0 | U.S. FDA Clearance of IND for Cetuximab Biosimilar HLX05-N henlius.com ↗ |
| 2026-04-14 | Shanghai Henlius Biotech | NMPA Grants IND Approval for Henlius' Cetuximab Biosimilar HLX05-N henlius.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HLX05 | “HLX05 Vs. Erbitux® (Cetuximab)” NCT06309043 ↗ |
| Action | Inhibit | “anti-EGFR” NCT06309043 ↗ |
| Modality | Monoclonal antibody | “monoclonal antibody” NCT06309043 ↗ |
| Route | Intravenous | “single intravenous dose” NCT06309043 ↗ |
| Target | EGFR | “anti-EGFR” NCT06309043 ↗ |