Drugs / HLX55
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT04169178 | Mar 2020 → Dec 2022 | cancer | Henlix, Inc | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2019-10-17 | Shanghai Henlius Biotech | Regulatory Henlius Innovative Anti-cMET Monoclonal Antibody HLX55 Received Clinical Approval from NMPA henlius.com ↗
Shanghai, China, October 17, 2019 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that Henlius has received an clinical approval from the National Medical Products Administration (NMPA) for its HLX55, an innovative monoclonal antibody（mAb） for injection, for the treatment of metastatic or recurrent solid tumors. |
| 2019-08-02 | Shanghai Henlius Biotech | Regulatory Henlius Innovative Anti-c-MET Monoclonal Antibody HLX55 Received IND Application Acceptance Notification from NMPA henlius.com ↗
Henlius has recently received an investigational new drug (IND) application acceptance notification from the National Medical Products Administration (NMPA) for its HLX55, an innovative monoclonal antibody（mAb） for injection, for the treatment of metastatic or recurrent solid tumors. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-03-04 | Shanghai Henlius Biotech | First Patient Dosed in Phase 1 Study of Henlius Innovative Anti-c-MET Monoclonal Antibody HLX55 for the Treatment of Advanced Solid Tumours henlius.com ↗ |
| 2019-10-17 | Shanghai Henlius Biotech | Henlius Innovative Anti-cMET Monoclonal Antibody HLX55 Received Clinical Approval from NMPA henlius.com ↗ |
| 2019-08-02 | Shanghai Henlius Biotech | Henlius Innovative Anti-c-MET Monoclonal Antibody HLX55 Received IND Application Acceptance Notification from NMPA 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 | HLX55 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04169178 ↗ |
| Known as | HLX55 monoclonal antibody for Injection | “HLX55 monoclonal antibody for Injection” NCT04169178 ↗ |
| Modality | Monoclonal antibody | “A humanized IgG2 monoclonal antibody targeting tyrosine-protein kinase MET (c-MET)” NCT04169178 ↗ |
| Target | MET | “A humanized IgG2 monoclonal antibody targeting tyrosine-protein kinase MET (c-MET)” NCT04169178 ↗ |