Drugs / HLX43
Trials 17
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06115642 | Nov 2023 → Jun 2026 overdue | metastatic malignant neoplasm | Shanghai Henlius Biotech | Enrolling by invitation | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07358585 | Jan 2026 → Jul 2027 expected | colon adenocarcinoma | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06848699 | Feb 2025 → Oct 2026 expected | non-small cell lung carcinoma | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 213 trials | ||||||
| Phase 2 | NCT07487519 | Apr 2026 → May 2027 expected | triple-negative breast carcinoma | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07459738 | Apr → Dec 2026 expected | hormone receptor-positive breast cancer | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07269782 | Jan → Jul 2026 overdue | non-small cell lung carcinoma | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 2 | NCT07253142 | Jan 2026 → Jun 2027 expected | non-small cell lung carcinoma, small cell lung carcinoma | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07301229 | Dec 2025 → Feb 2028 expected | pancreatic ductal adenocarcinoma | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07106892 | Sep 2025 → Dec 2026 expected | colorectal cancer | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 2 | NCT07115485 | Sep 2025 → Aug 2027 expected | gastroesophageal adenocarcinoma | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 2 | NCT06907615 | Jun 2025 → Apr 2028 expected | non-small cell lung carcinoma | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 2 | NCT06857279 | Apr 2025 → Dec 2027 expected | head and neck carcinoma | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 2 | NCT06839066 | Apr 2025 → Nov 2026 expected | nasopharyngeal carcinoma | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 2 | NCT06742892 | Mar 2025 → Oct 2026 expected | hepatocellular carcinoma | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 2 | NCT06769152 | Feb 2025 → Dec 2026 expected | cervical cancer, ovarian cancer | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 2 | NCT06769113 | Jan 2025 → Oct 2026 expected | esophageal cancer | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07459751 | May 2026 → Jan 2030 expected | non-small cell squamous lung carcinoma | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 24
| Date | Issuer | Release |
|---|---|---|
| 2026-09-15 | Shanghai Henlius Biotech | Results WCLC 2026 | PD-L1-Targeting ADC HLX43 Achieves Confirmed ORR of Over 40% in Previously Treated TSCC, Advancing Treatment for Difficult-to-Treat Tumors henlius.com ↗
The clinical data demonstrated encouraging anti-tumor activity and a favorable safety and tolerability profile of HLX43 in advanced TSCC, marking an important early clinical proof-of-concept milestone for this novel molecule and further supporting its clinical development potential and potential therapeutic window. |
| 2026-08-20 | Shanghai Henlius Biotech | Results WCLC 2026 Preview | HLX43, a Potential First PD-L1 ADC for TSCC, Shows Promising Efficacy with an ORR of 39.4% in Previously Treated Patients henlius.com ↗
According to the updated abstract, HLX43 continues to demonstrate promising efficacy and manageable safety in patients with advanced or metastatic TSCC who experienced disease progression after first-line platinum-based chemotherapy, thereby addressing the unmet clinical need for effective treatments for advanced TSCC. |
| 2026-07-31 | Shanghai Henlius Biotech | Regulatory Henlius Announces IND Approval for Its Innovative PD-L1 ADC HLX43 in Combination with Bevacizumab ± Chemotherapy henlius.com ↗
Henlius (2696.HK) today announced that the investigational new drug (IND) application for HLX43, the company’s innovative programmed death-ligand 1 (PD-L1)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab with or without chemotherapy, for the treatment of advanced/metastatic solid tumors has been approved by China’s National Medical Products Administration (NMPA). |
| 2026-06-17 | Shanghai Henlius Biotech | Regulatory Exploring Earlier-Stage Treatment Potential: Henlius’ Phase 2 Clinical Trial of HLX43 in Combination with Serplulimab for Neoadjuvant Treatment of NSCLC Approved for Clinical Trial in Australia henlius.com ↗ |
| 2026-05-31 | Shanghai Henlius Biotech | Results ASCO 2026 | Henlius Accelerates Global Development of Its PD-L1 ADC, Demonstrating Promising Activity Across Multiple Difficult-to-Treat NSCLC Subgroups and Potential for Earlier-Line Development henlius.com ↗
The results demonstrated that HLX43 monotherapy exhibited encouraging antitumour activity and a manageable safety profile in previously treated NSCLC patients. |
| 2026-05-06 | Shanghai Henlius Biotech | Regulatory Henlius' HLX43 (anti-PD-L1 ADC) Receives PMDA’s Acknowledge to Initiate Global Phase 2/3 Trial in sqNSCLC henlius.com ↗
Shanghai Henlius Biotech, Inc. (2696.HK) today announced that its innovative anti-PD-L1 antibody–drug conjugate (ADC), HLX43, has been permitted by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to conduct the HLX43-NSCLC302 study — an international, multicenter phase 2/3 clinical trial in patients with advanced squamous non-small cell lung cancer (sqNSCLC). |
| 2026-03-19 | Shanghai Henlius Biotech | Results Henlius to Showcase Seven FIC/BIC Innovative Assets at AACR 2026, Highlighting Accelerated Early-Stage Innovation henlius.com ↗
Preclinical studies reveal that protease-mediated payload release and immuno-oncology/immunomodulatory effects contribute to the antitumor activity of HLX43 |
| 2026-01-27 | Shanghai Henlius Biotech | Regulatory Henlius Receives an IND Approval for Its PD-L1-Targeting ADC HLX43 in Combination with Anti-PD-1 mAb Serplulimab and Novel Anti-EGFR mAb HLX07 henlius.com ↗ |
| 2026-01-09 | Shanghai Henlius Biotech | Results Henlius Debuts Phase 2 Results for Its Broad Anti-tumor PD-L1 ADC HLX43 in Second-Line or Subsequent Treatment of Esophageal Squamous Cell Carcinoma at ASCO GI 2026 henlius.com ↗
In the 3 mg/kg cohort, the ORR and DCR reached 61.5% and 100%, respectively, with a cORR of 38.5%. |
| 2025-12-05 | Shanghai Henlius Biotech | Results Henlius' PD-L1 ADC HLX43 Cervical Cancer Data Debuts as Proffered Paper at 2025 ESMO Asia henlius.com ↗
The results demonstrated encouraging antitumor activity, providing further evidence of its broad-spectrum antitumor activity, previously observed in non-small cell lung cancer and thymic carcinoma. |
| 2025-11-03 | Shanghai Henlius Biotech | Results Henlius Presents Updated Clinical Data on PD-L1 ADC HLX43 for NSCLC at 2025 International Summit on Frontiers and Innovation in Lung Cancer henlius.com ↗
This marks the first time to incorporate results from the multi-regional phase 2 clinical study of HLX43, highlighting the efficacy and safety of the product at the recommended phase 2/3 dose (RP2/3D). |
| 2025-10-20 | Shanghai Henlius Biotech | Regulatory Henlius Receives Orphan Drug Designation for PD-L1 ADC HLX43 in the U.S. for Thymic Epithelial Tumors henlius.com ↗
FDA's grant of ODD for HLX43 in Thymic Epithelial Tumors (TETs) marks another milestone in its global development, qualifying it for certain incentives in R&D, registration, and commercialization in the U.S. |
| 2025-09-30 | Shanghai Henlius Biotech | Regulatory Henlius Receives the NMPA IND Approval for Its PD-L1-Targeting ADC HLX43 in Combination with Novel Anti-EGFR mAb HLX07 henlius.com ↗
has been approved by the China National Medical Products Administration (NMPA) |
| 2025-09-07 | Shanghai Henlius Biotech | Results The Updated Clinical Results for PD-L1 ADC HLX43 at the 2025 WCLC, Demonstrate Outstanding Efficacy in NSCLC henlius.com ↗
The ORR was 28.6% for ≥4L squamous NSCLC patients, 30.0% for those who previously received docetaxel; cORR was 46.7% for EGFR wild-type non-squamous NSCLC, and 60.0% for those receiving HLX43 at 2.5 mg/kg |
| 2025-08-28 | Shanghai Henlius Biotech | Results Henlius Featured at the 2025 Evercore China Biotech Summit henlius.com ↗
Notably, in the EGFR wild-type non-squamous NSCLC (nsNSCLC) subgroup, HLX43 achieved an ORR of 47.4%, while maintaining a favourable safety profile. |
| 2025-08-14 | Shanghai Henlius Biotech | Results Release of the Updated Abstract for Henlius’ PD-L1 ADC HLX43 at 2025 WCLC henlius.com ↗
According to the updated abstract, HLX43 continues to demonstrate a high response rate in patients with advanced solid tumors, particularly in pretreated NSCLC patients who failed checkpoint inhibitor therapy. |
| 2025-08-07 | Shanghai Henlius Biotech | Regulatory Henlius to Initiate a Phase 1 Multicenter Study in US of Its PD-L1 ADC HLX43 for the Treatment of Thymic Carcinoma henlius.com ↗ |
| 2025-07-09 | Shanghai Henlius Biotech | Regulatory Henlius Receives Global Regulatory Approvals for Phase 2 MRCT of Its PD-L1 ADC HLX43 on NSCLC henlius.com ↗ |
| 2025-06-03 | Shanghai Henlius Biotech | Results Results from the Phase 1 Clinical Trial of Henlius PD-L1 ADC HLX43 Released at 2025 ASCO Annual Meeting henlius.com ↗
The results presented at the 2025 ASCO Annual Meeting were from the phase 1 clinical study, which evaluated the safety, tolerability, and pharmacokinetic characteristics of HLX43 (Anti-PD-L1 ADC) in patients with advanced/metastatic solid tumors. |
| 2025-01-06 | Shanghai Henlius Biotech | Regulatory Henlius Receives the NMPA IND Approval for Its PD-L1-Targeting ADC HLX43 in Combination with Novel Anti-PD-1 mAb Serplulimab henlius.com ↗ |
| 2024-12-04 | Shanghai Henlius Biotech | Regulatory Henlius Receives IND Approval from NMPA for a Phase 1b/2 Clinical Trial of Its Novel PD-L1-Targeting ADC HLX43 henlius.com ↗ |
| 2023-11-27 | Shanghai Henlius Biotech | Regulatory Henlius Receives the FDA IND Approval for Its PD-L1-Targeting ADC Candidate HLX43 henlius.com ↗
Shanghai, China, November, 27, 2023 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the investigational new drug (IND) application of HLX43 for Injection, the antibody-drug conjugate (ADC) product that developed by the company based on the collaboration with MediLink Therapeutics, has been approved by the U.S. Food and Drug Administration (FDA), for the treatment of advance/metastatic solid tumours. |
| 2023-10-27 | Shanghai Henlius Biotech | Regulatory Henlius Announces NMPA Approvals of Two ADC Candidates for IND henlius.com ↗
the investigational new drug (IND) applications of HLX42 for Injection, a novel EGFR-targeting antibody-drug conjugate (ADC) as well as HLX43, a novel PD-L1-targeting ADC, have been approved by the National Medical Products Administration (NMPA) |
| 2023-10-24 | Shanghai Henlius Biotech | Results Results From the Preclinical Study of HLX43, a Potential FIC PD-L1-Targeting ADC Released at 2023 ESMO henlius.com ↗ |
All press releases naming this drug 39 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HLX43 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06907615 ↗ |
| Action | Inhibit | “HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.” NCT06742892 ↗ |
| Modality | Other / unclassified | “HLX43 (Anti-PD-L1 ADC)” NCT06115642 ↗ |
| Route | Intravenous | “administered with HLX43 at different doses via intravenous infusion” NCT06115642 ↗ |