Drugs / HLX3901
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07416695 | Apr 2026 → May 2028 expected | small cell lung carcinoma | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-04-22 | Shanghai Henlius Biotech | Results Henlius Showcases HLX3902 Preclinical Data at AACR 2026, Highlighting Its CD28-Enabled Multispecific TCE Platform henlius.com ↗
From a safety perspective, HLX3901 exhibited reduced non-specific CD4⁺ and CD8⁺ T cell activation and lower cytokine release (including IL-2, IFN-γ, TNF-α, and IL-6) compared with Tarlatamab. |
| 2026-03-09 | Shanghai Henlius Biotech | Regulatory Henlius Announces IND Approval for Its Proprietary Next Generation Tetra-Specific T-Cell Engager HLX3901 henlius.com ↗
the Investigational New Drug (IND) application for HLX3901, a novel tetra-specific antibody independently developed based on the company's proprietary T-cell engager (TCE) platform that targets DLL3xDLL3xCD3xCD28 , has been approved by the National Medical Products Administration (NMPA) |
| 2026-03-09 | Shanghai Henlius Biotech | Regulatory IND Application for Potential First‑in‑Class B7‑H3–Targeting Sialidase Fusion Protein HLX316 Approved in China henlius.com ↗
In addition, HLX97, a potential best-in-class KAT6A/B inhibitor, and HLX3901, a DLL3xDLL3xCD3xCD28 tetra‑specific T‑cell engager (TCE) developed from Henlius’ proprietary TCE platform, received IND acceptance concurrently with HLX316. |
| 2025-12-30 | Shanghai Henlius Biotech | Regulatory Henlius Marks Innovation-Driven Milestone with Three Concurrent IND Acceptances henlius.com ↗
Henlius (2696.HK) announced that the Investigational New Drug (IND) applications for three differentiated innovative candidates have been accepted by the National Medical Products Administration (NMPA). |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-04-30 | Shanghai Henlius Biotech | Henlius' Next-Generation Tetra-Specific TCE HLX3901 Doses First Patient in Phase 1 Study, Advancing Multi-Specific Platform into Clinical Validation henlius.com ↗ |
| 2026-04-22 | Shanghai Henlius Biotech | Henlius Showcases HLX3902 Preclinical Data at AACR 2026, Highlighting Its CD28-Enabled Multispecific TCE Platform henlius.com ↗ |
| 2026-03-09 | Shanghai Henlius Biotech | Henlius Announces IND Approval for Its Proprietary Next Generation Tetra-Specific T-Cell Engager HLX3901 henlius.com ↗ |
| 2026-03-09 | Shanghai Henlius Biotech | IND Application for Potential First‑in‑Class B7‑H3–Targeting Sialidase Fusion Protein HLX316 Approved in China henlius.com ↗ |
| 2025-12-30 | Shanghai Henlius Biotech | Henlius Marks Innovation-Driven Milestone with Three Concurrent IND Acceptances henlius.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HLX3901 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07416695 ↗ |
| Route | Intravenous | “HLX3901 will be administered as an intravenous (IV) infusion.” NCT07416695 ↗ |
| Target | CD28 | “HLX3901 (DLL3 × DLL3 × CD3 × CD28 Tetra-specific Antibody)” NCT07416695 ↗ |
| Target | DLL3 | “HLX3901 (DLL3 × DLL3 × CD3 × CD28 Tetra-specific Antibody)” NCT07416695 ↗ |