Drugs / HLX319
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | Her2-receptor negative breast cancer | 2026-04-01 | “Its marketing authorization applications have also been accepted for review by the NMPA, Health Canada, and the European Medicines Agency (EMA).” henlius.com ↗ |
| Filed | EU (EMA) | — | Her2-receptor negative breast cancer | 2026-04-01 | “Its marketing authorization applications have also been accepted for review by the NMPA, Health Canada, and the European Medicines Agency (EMA).” henlius.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07601620 | Jul 2026 → Apr 2027 expected | HER2 positive breast carcinoma | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07495930 | Apr → Jul 2026 overdue | — | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2026-04-01 | Shanghai Henlius Biotech | Regulatory Enhancing Treatment for Breast Cancer: China’s First Subcutaneous Pertuzumab/Trastuzumab Combination HLX319 Approved for Clinical Trial henlius.com ↗
April 1, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK) today announced that the Investigational New Drug (IND) application for HLX319, the company's self-developed, fixed-dose subcutaneous injection of pertuzumab and trastuzumab, has been approved by the China National Medical Products Administration (NMPA). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-04-10 | Shanghai Henlius Biotech | Henlius Announces First Patient Dosed in Clinical Trial of HLX319, China’s First Subcutaneous Fixed-Dose Injection of a Pertuzumab/Trastuzumab Biosimilar henlius.com ↗ |
| 2026-04-01 | Shanghai Henlius Biotech | Enhancing Treatment for Breast Cancer: China’s First Subcutaneous Pertuzumab/Trastuzumab Combination HLX319 Approved for Clinical Trial henlius.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HLX319 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07601620 ↗ |
| Modality | Monoclonal antibody | “HLX319 is a biosimilar of pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection)” NCT07601620 ↗ |