Drugs / HLX70
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05429385 | Dec 2020 → Sep 2021 | COVID-19 | Shanghai Henlius Biotech | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT04561076 | Dec 2020 → Sep 2021 | COVID-19 | Hengenix Biotech Inc | Withdrawn | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2020-10-05 | Shanghai Henlius Biotech | Regulatory Investigational New Drug Application of Henlius SARS-CoV-2 Neutralizing Antibody HLX70 Approved by US FDA henlius.com ↗
With this IND application, Henlius becomes the first Chinese biopharmaceutical company that has independently filed an IND application for a SARS-CoV-2 neutralizing antibody to the U.S. FDA and has received the approval. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2020-10-05 | Shanghai Henlius Biotech | Investigational New Drug Application of Henlius SARS-CoV-2 Neutralizing Antibody HLX70 Approved by US FDA henlius.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HLX70 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05429385 ↗ |
| Modality | Monoclonal antibody | “Anti-spike protein-1 monoclonal antibody (mAb)” NCT04561076 ↗ |
| Route | Intravenous | “Single-dose, intravenous infusion” NCT04561076 ↗ |