Drugs / HLX53
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05394168 | Dec 2022 → Dec 2024 | — | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06349980 | Aug 2024 → Feb 2027 expected | hepatocellular carcinoma | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2024-11-05 | Shanghai Henlius Biotech | Results Latest Research into the Differentiated Mechanisms of Action of Serplulimab Published in mAbs Journal henlius.com ↗
Furthermore, the study found that the combined treatment with serplulimab and another immune checkpoint inhibitor, such as Henlius’ innovative anti-TIGIT Fc fusion protein HLX53 and anti-LAG-3 mAb HLX26, enhanced anti-tumour activity compared with serplulimab alone, which shows promise of more efficient clinical treatment options for cancer patients. |
| 2024-04-17 | Shanghai Henlius Biotech | Regulatory IND Application for the Clinical Trial of Novel Anti-TIGIT Fc Fusion Protein HLX53 in Combination with HANSIZHUANG Plus HANBEITAI for the First-Line Treatment of Locally Advanced or Metastatic Hepatocellular Carcinoma Patients Approved by NMPA henlius.com ↗
Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug application (IND) for the clinical trial of HLX53, an anti-TIGIT Fc fusion protein, in combination with HANSIZHUANG (serplulimab, HLX10) and HANBEITAI (bevacizumab, HLX04) for the first line treatment of locally advanced or metastatic hepatocellular carcinoma, has been approved by the National Medical Products Administration (NMPA). |
| 2022-06-30 | Shanghai Henlius Biotech | Regulatory Henlius’ Novel Anti-TIGIT Fc Fusion Protein HLX53 IND Approved by NMPA henlius.com ↗
Shanghai, China, June, 30th, 2022 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug application (IND) of HLX53, an anti-TIGIT Fc fusion protein, in patients with advanced/metastatic solid tumors or lymphomas has been approved by the National Medical Products Administration (NMPA). |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-11-05 | Shanghai Henlius Biotech | Latest Research into the Differentiated Mechanisms of Action of Serplulimab Published in mAbs Journal henlius.com ↗ |
| 2024-04-17 | Shanghai Henlius Biotech | IND Application for the Clinical Trial of Novel Anti-TIGIT Fc Fusion Protein HLX53 in Combination with HANSIZHUANG Plus HANBEITAI for the First-Line Treatment of Locally Advanced or Metastatic Hepatocellular Carcinoma Patients Approved by NMPA henlius.com ↗ |
| 2022-12-09 | Shanghai Henlius Biotech | First Patient Dosed in the Phase 1 Clinical Trial of Henlius’ Novel Anti-TIGIT Fc Fusion Protein HLX53 henlius.com ↗ |
| 2022-06-30 | Shanghai Henlius Biotech | Henlius’ Novel Anti-TIGIT Fc Fusion Protein HLX53 IND Approved by NMPA henlius.com ↗ |
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 | HLX53 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05394168 ↗ |
| Action | Inhibit | “anti-TIGIT Fc fusion protein” NCT05394168 ↗ |
| Modality | Protein / enzyme biologic | “HLX53 (an anti-TIGIT Fc fusion protein)” NCT05394168 ↗ |
| Route | Intravenous | “administered by intravenous infusion” NCT05394168 ↗ |
| Target | TIGIT | “HLX53 (an Anti-TIGIT Fc Fusion Protein)” NCT06349980 ↗ |