Drugs / HLX316
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07541534 | May 2026 → Dec 2027 expected | — | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-04-20 | Palleon Pharmaceuticals, Inc. | Results Palleon Pharmaceuticals Presents First-in-Class B7-H3 Targeted Sialidase at the 2026 AACR Annual Meeting palleonpharma.com ↗
Palleon Pharmaceuticals today presented preclinical data and announced the initiation of a human clinical trial for E-688/HLX316, a first-in-class B7-H3 targeted sialidase, in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting “New Drugs on the Horizon” session. |
| 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 ↗
Shanghai, China, March 9, 2026 — Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Investigational New Drug (IND) application for HLX316, a potential first‑in‑class (FIC) B7‑H3–targeting sialidase fusion protein, has been approved by the National Medical Products Administration (NMPA) of China. |
| 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 6 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HLX316 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07541534 ↗ |
| Modality | Protein / enzyme biologic | “HLX316 (B7-H3 Targeting Sialidase Fc Fusion Protein)” NCT07541534 ↗ |
| Route | Intravenous | “HLX316 administered by intravenous infusion” NCT07541534 ↗ |