Drugs / HLX48
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | — | 2026-04-23 | “The investigational new drug (IND) application for HLX48 has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA)” henlius.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07473726 | Jun 2026 → Mar 2027 expected | — | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-05-21 | Shanghai Henlius Biotech | Regulatory Henlius Announces IND Approval from NMPA for Its Proprietary c-Met/EGFR Bispecific ADC HLX48 henlius.com ↗
May 21, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that its independently developed c-Met/EGFR bispecific antibody–drug conjugate (ADC), HLX48 for injection, has been approved by the National Medical Products Administration (NMPA), for the treatment of advanced and metastatic solid tumors. |
| 2026-05-13 | Shanghai Henlius Biotech | Regulatory Henlius' c-Met/EGFR Bispecific ADC Approved for Clinical Trial in Australia henlius.com ↗
May 13, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that its independently developed c-Met/EGFR bispecific antibody–drug conjugate (ADC), HLX48 for injection, has received approval from the Human Research Ethics Committee (HREC) in Australia and been acknowledged by the Therapeutic Goods Administration (TGA). |
| 2026-04-23 | Shanghai Henlius Biotech | Results Henlius Presents Four Hanjugator™ ADCs at AACR 2026, with Multiple Potential Best-in-Class Assets Advancing henlius.com ↗
In HT29 and SW48 human colorectal cancer CDX models, HLX48 also showed superior efficacy compared with AZD9592. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-30 | Shanghai Henlius Biotech | Henlius Doses First Patient with c-MET x EGFR Bispecific ADC HLX48 henlius.com ↗ |
| 2026-05-21 | Shanghai Henlius Biotech | Henlius Announces IND Approval from NMPA for Its Proprietary c-Met/EGFR Bispecific ADC HLX48 henlius.com ↗ |
| 2026-05-13 | Shanghai Henlius Biotech | Henlius' c-Met/EGFR Bispecific ADC Approved for Clinical Trial in Australia henlius.com ↗ |
| 2026-04-23 | Shanghai Henlius Biotech | Henlius Presents Four Hanjugator™ ADCs at AACR 2026, with Multiple Potential Best-in-Class Assets Advancing 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 | HLX48 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07473726 ↗ |
| Route | Intravenous | “administered HLX48 at different doses via intravenous infusion” NCT07473726 ↗ |
| Target | EGFR | “EGFR/c-MET Bispecific Antibody-Drug Conjugate” NCT07473726 ↗ |
| Target | MET | “EGFR/c-MET Bispecific Antibody-Drug Conjugate” NCT07473726 ↗ |