Drugs / EMUNKITUG
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05238883 | Mar 2022 → Dec 2026 expected | cervical cancer, gastric cancer, head and neck squamous cell carcinoma, melanoma +5 | HiFiBiO Therapeutics | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2023-10-09 | HiFiBiO Therapeutics | Regulatory HiFiBiO Therapeutics Receives Approval from Chinese NMPA for IND Application for HFB200301, an Innovative Anti-Tumor Monoclonal Antibody hifibio.com ↗
The approval of our HFB200301 IND by the NMPA represents yet another pivotal milestone for the program, confirming our strong commitment to developing safe and effective treatments for cancer patients globally. |
| 2021-11-01 | HiFiBiO Therapeutics | Regulatory HiFiBiO Therapeutics Receives FDA Clearance of IND Application for HFB200301 hifibio.com ↗
HiFiBiO Therapeutics, a multinational clinical-stage biotherapeutics company today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for HFB200301. |
All press releases naming this drug 6 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | EMUNKITUG | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068246 ↗ |
| Known as | HFB200301 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05238883 ↗ |
| Action | Activate | “HFB200301 (TNFR2 Agonist Antibody)” NCT05238883 ↗ |
| Modality | Monoclonal antibody | — CHEMBL6068246 ↗ |
| Route | Intravenous | “Participants will be administered HFB200301 at dose levels 1-5 as an intravenous infusion to determine the Recommended Dose for Expansion (RDE).” NCT05238883 ↗ |