Drugs / HLX18
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07518043 | Jun 2026 → Aug 2027 expected | gastroesophageal cancer, melanoma, urothelial carcinoma | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-03-20 | Shanghai Henlius Biotech | Regulatory NMPA Grants IND Approval for Henlius’ Nivolumab Biosimilar HLX18 Following U.S. FDA Clearance henlius.com ↗
Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug (IND) application for HLX18, a proposed nivolumab biosimilar independently developed by the company, has been approved by the China National Medical Products Administration (NMPA) for the treatment of certain resected solid tumors. |
| 2025-12-19 | Shanghai Henlius Biotech | Regulatory U.S. FDA Clearance of IND for Nivolumab Biosimilar HLX18 henlius.com ↗
Shanghai, China, December 19, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced the investigational new drug (IND) application for its HLX18, a proposed nivolumab biosimilar independently developed by the company, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of certain resected solid tumors. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-16 | Shanghai Henlius Biotech | First Patient Dosed in China for International Multi-centre Phase 1 Clinical Trial of Henlius’ Nivolumab Biosimilar HLX18 henlius.com ↗ |
| 2026-03-20 | Shanghai Henlius Biotech | NMPA Grants IND Approval for Henlius’ Nivolumab Biosimilar HLX18 Following U.S. FDA Clearance henlius.com ↗ |
| 2025-12-19 | Shanghai Henlius Biotech | U.S. FDA Clearance of IND for Nivolumab Biosimilar HLX18 henlius.com ↗ |
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HLX18 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07518043 ↗ |