Drugs / HLX97
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07480681 | Mar 2026 → Mar 2028 expected | — | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 2026-03-05 | Shanghai Henlius Biotech | Regulatory Henlius Receives IND Approval for Its Potential BIC Novel Oral KAT6A/B Small Molecule Inhibitor HLX97 henlius.com ↗
the NMPA has approved the IND application for HLX97 |
| 2025-12-30 | Shanghai Henlius Biotech | Regulatory Henlius Marks Innovation-Driven Milestone with Three Concurrent IND Acceptances henlius.com ↗
Shanghai, China, December 30, 2025 – 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). |
| 2025-04-28 | Shanghai Henlius Biotech | Results Preclinical Results of Henlius’ Multiple Innovative Candidates Debut at AACR 2025 henlius.com ↗
HLX97 exhibited superior enzymatic inhibition and enhanced selectivity against KAT5/7/8, along with more potent cytotoxic effects in ZR-75-1 cells, in head-to-head comparisons with PF-07248144. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-05-13 | Shanghai Henlius Biotech | Henlius' potential BIC oral KAT6A/B inhibitor HLX97 completes first patient dosing in Phase 1, aiming to overcome endocrine therapy resistance in breast cancer 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 ↗ |
| 2026-03-05 | Shanghai Henlius Biotech | Henlius Receives IND Approval for Its Potential BIC Novel Oral KAT6A/B Small Molecule Inhibitor HLX97 henlius.com ↗ |
| 2025-12-30 | Shanghai Henlius Biotech | Henlius Marks Innovation-Driven Milestone with Three Concurrent IND Acceptances henlius.com ↗ |
| 2025-04-28 | Shanghai Henlius Biotech | Preclinical Results of Henlius’ Multiple Innovative Candidates Debut at AACR 2025 henlius.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HLX97 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07480681 ↗ |
| Action | Inhibit | “HLX97 (KAT6A/B Small Molecule Inhibitor)” NCT07480681 ↗ |
| Modality | Small molecule | “HLX97 (KAT6A/B Small Molecule Inhibitor)” NCT07480681 ↗ |
| Route | Oral | “HLX 97 will be taken as an oral medication.” NCT07480681 ↗ |
| Target | KAT6A | “HLX97 (KAT6A/B Small Molecule Inhibitor)” NCT07480681 ↗ |