Drugs / HLX17
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07160335 | Sep 2025 → Apr 2027 expected | melanoma, non-small cell lung carcinoma, renal cell carcinoma | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06847334 | Apr 2025 → Apr 2027 expected | non-small cell lung carcinoma | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-09-09 | Shanghai Henlius Biotech | Regulatory U.S. FDA Clearance of IND for Pembrolizumab Biosimilar HLX17 henlius.com ↗
Shanghai Henlius Biotech, Inc. (2696.HK) announced the investigational new drug (IND) application for its HLX17, a proposed pembrolizumab biosimilar independently developed by the company, was approved by the U.S. Food and Drug Administration (FDA) |
| 2024-09-02 | Shanghai Henlius Biotech | Regulatory IND Application of Henlius’ Pembrolizumab Biosimilar Approved by NMPA henlius.com ↗
the investigational new drug (IND) application for clinical trial of HLX17, a pembrolizumab biosimilar independently developed by the company, was approved by the National Medical Products Administration (NMPA) |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-09-09 | Shanghai Henlius Biotech | U.S. FDA Clearance of IND for Pembrolizumab Biosimilar HLX17 henlius.com ↗ |
| 2024-09-02 | Shanghai Henlius Biotech | IND Application of Henlius’ Pembrolizumab Biosimilar Approved by NMPA henlius.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HLX17 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07160335 ↗ |
| Route | Intravenous | “administered as IV infusion” NCT06847334 ↗ |