Drugs / HLX26
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05400265 | Jul 2022 → Aug 2023 | — | Shanghai Henlius Biotech | Completed | No outcome recorded |
| Phase 1 | NCT05078593 | Oct 2021 → Aug 2023 | cancer, lymphoma | Shanghai Henlius Biotech | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05787613 | Jul 2023 → Feb 2026 overdue | non-small cell lung carcinoma | Shanghai Henlius Biotech | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05584137 | Jun → Dec 2023 | colorectal carcinoma | Shanghai Henlius Biotech | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 6
| 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. |
| 2023-12-04 | Shanghai Henlius Biotech | Results Results from Four Phase 1/2 Clinical Trials of Henlius’ Innovative Products Released at 2023 ESMO Asia henlius.com ↗
were released as poster presentations at European Society for Medical Oncology Asia (ESMO Asia) Congress 2023. |
| 2023-05-26 | Shanghai Henlius Biotech | Results 2023 ASCO Annual Meeting Released Clinical Data of Two Henlius Trials henlius.com ↗ |
| 2023-05-05 | Shanghai Henlius Biotech | Regulatory IND application of phase 2 clinical trial of HANSIZHUANG in combination with novel anti-LAG-3 mAb and chemotherapy for the first-line treatment of advanced non-small cell lung cancer patients was approved by NMPA henlius.com ↗ |
| 2022-04-29 | Shanghai Henlius Biotech | Regulatory IND Application of Phase I Clinical Trial of HANSIZHUANG in combination with Innovative Anti-LAG-3 mAb for the Treatment of Advanced/Metastatic Solid Tumours or Lymphomas Patients was Approved by NMPA henlius.com ↗ |
| 2021-04-15 | Shanghai Henlius Biotech | Regulatory Henlius Received IND Approval for Its Novel Anti-LAG-3 mAb HLX26 from NMPA henlius.com ↗
Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug (IND) application of its HLX26 (recombinant anti-LAG-3 human monoclonal antibody injection) has been approved by the National Medical Products Administration (NMPA) for treatment of solid tumors and lymphomas. |
All press releases naming this drug 7 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HLX26 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05078593 ↗ |
| Action | Inhibit | “it can block LAG-3 and its ligand interaction” PMID 41538111 ↗ Jan 2026 |
| Modality | Monoclonal antibody | “BACKGROUND: HLX26 is a novel, recombinant humanized anti-LAG-3 IgG4 monoclonal antibody” PMID 41538111 ↗ Jan 2026 |
| Route | Intravenous | “the patients will be given different doses(60mg, 150mg, 300mg, 500mg, 800mg Q3W) of HLX26 intravenously” NCT05078593 ↗ |
| Target | LAG3 | “HLX26 is a novel, recombinant humanized anti-LAG-3 IgG4 monoclonal antibody that exhibits high affinity for LAG-3” PMID 41538111 ↗ Jan 2026 |