Drugs / HLX3902
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | — | castration-resistant prostate carcinoma | 2026-05-21 | “has been filed with the Therapeutic Goods Administration (TGA).” henlius.com ↗ |
| Filed | China (NMPA) | — | castration-resistant prostate carcinoma | 2026-04-22 | “Its IND application has been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA).” henlius.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07533708 | May 2026 → Jun 2027 expected | castration-resistant prostate carcinoma | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-06-17 | Shanghai Henlius Biotech | Regulatory STEAP1×CD3×CD28 Tri-specific TCE HLX3902 Receives China Clinical Approval, Promising Breakthrough in “Cold Tumour” Therapy henlius.com ↗
Recently, it has also received clinical trial authorization in Australia. |
| 2026-05-22 | Shanghai Henlius Biotech | Regulatory Henlius' STEAP1×CD3×CD28 Trispecific TCE HLX3902 Approved for Clinical Trial in Australia，Showing Potential Against Cold Tumours henlius.com ↗
HLX3902—a tri-specific antibody targeting STEAP1×CD3×CD28 developed on the company’s proprietary immune cell engager platform—has received approval from the Human Research Ethics Committee (HREC) in Australia and has been filed with the Therapeutic Goods Administration (TGA). |
| 2026-04-22 | Shanghai Henlius Biotech | Results Henlius Showcases HLX3902 Preclinical Data at AACR 2026, Highlighting Its CD28-Enabled Multispecific TCE Platform henlius.com ↗
Shanghai Henlius Biotech, Inc. (2696.HK) today announced the first presentation of preclinical data for its novel CD3×CD28×STEAP1 trispecific T cell engager (TCE), HLX3902, at the 2026 Annual Meeting of the American Association for Cancer Research (AACR) in a poster session. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-30 | Shanghai Henlius Biotech | Henlius' Announced First Patient Dosed for Its STEAP1×CD3×CD28 Tri-specific TCE HLX3902 henlius.com ↗ |
| 2026-06-17 | Shanghai Henlius Biotech | STEAP1×CD3×CD28 Tri-specific TCE HLX3902 Receives China Clinical Approval, Promising Breakthrough in “Cold Tumour” Therapy henlius.com ↗ |
| 2026-05-22 | Shanghai Henlius Biotech | Henlius' STEAP1×CD3×CD28 Trispecific TCE HLX3902 Approved for Clinical Trial in Australia，Showing Potential Against Cold Tumours 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 ↗ |
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 | HLX3902 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07533708 ↗ |