HLX43 / Fosun Pharma, MediLink, Shanghai Henlius Biotech - LARVOL DELTA

A Phase II clinical study evaluating the efficacy and safety of HLX43 (anti-PD-L1 ADC) in subjects with advanced stage pancreatic cancer (ChiCTR) - P2 | N=100 | Not yet recruiting | Sponsor: Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center

New P2 trial • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Efficacy and safety of HLX43 in previously treated advanced gastric cancer: a randomized phase 2 study (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Gastric Cancer • Oncology • Solid Tumor

Efficacy and safety of HLX43 (anti–PD-L1 ADC) in patients with advanced non–small cell lung cancer. (ASCO 2026) - P1, P2 | "In the 2.0 mg/kg group, investigator-assessed ORR was 36.4% for squamous NSCLC (n = 33); among these patients, ORR was 40.0% for those who previously failed docetaxel (n = 15). HLX43 exhibited promising efficacy in patients with heavily pretreated advanced NSCLC, regardless of histology subtypes, and PD-L1 expression, along with manageable tolerability. Further investigation is warranted."

ADC • Clinical • IO biomarker • Metastases • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • PD-L1

Efficacy and Safety of HLX43, a PD-L1-Targeting ADC, in Pretreated Advanced Thymic Squamous Cell Carcinoma: Results From a Phase I Trial (IASLC-WCLC 2026) - P1 | "Conclusions : HLX43 exhibited promising efficacy and manageable safety in patients with previously treated TSCC, thereby addressing the unmet clinical need for effective treatments for advanced TSCC. Further investigation of HLX43 is warranted."

ADC • Clinical • IO biomarker • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Squamous Cell Carcinoma

Henlius to Present Updated HLX43 TSCC Data and Seven Serplulimab Lung Cancer Studies at WCLC 2026 (Henlius Press Release) - "At this year's meeting, Henlius will present multiple new findings from its innovative pipeline and marketed products, including Phase 1 study data for the PD-L1-targeting antibody-drug conjugate (ADC) HLX43 in thymic squamous cell carcinoma (TSCC), as well as seven studies of the anti-PD-1 monoclonal antibody(mAb) serplulimab (trade name in Europe: Hetronifly) in extensive-stage small cell lung cancer (ES-SCLC), limited-stage small cell lung cancer (LS-SCLC), and pulmonary large-cell neuroendocrine carcinoma (LCNEC)."

Clinical data • P1 data • Large Cell Neuroendocrine Carcinoma • Small Cell Lung Cancer • Squamous Cell Carcinoma • Thymic Carcinoma

Shanghai Henlius Biotech has received approval from China’s National Medical Products Administration to begin clinical trials of HLX43, an antibody-drug conjugate targeting PD-L1, in combination with bevacizumab with or without chemotherapy for advanced or metastatic solid tumours in the Chinese Mainland. (TipRanks)

New trial • Solid Tumor

A Phase II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Subjects With Advanced Lung Cancer (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Shanghai Henlius Biotech, Inc. announced that China’s National Medical Products Administration has approved the investigational new drug application for a phase 1 clinical trial of HLX37 in combination with chemotherapy or with HLX43 in patients with advanced or metastatic solid tumours. (TipRanks) - "The company plans to initiate these trials in the Chinese Mainland, expanding the clinical evaluation of its PD-L1/VEGF bispecific antibody and PD-L1-targeting ADC."

New P1 trial • Solid Tumor

A Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 Monotherapy or HLX43 in Combination With HLX07 Versus Docetaxel in Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2/3 | N=706 | Recruiting | Sponsor: Shanghai Henlius Biotech | Enrolling by invitation ➔ Recruiting

Enrollment status • Monotherapy • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Efficacy and safety of HLX43 (an anti–PD-L1 ADC) in previously treated recurrent/metastatic nasopharyngeal carcinoma: A multicenter, randomized phase 2 study. (ASCO 2026) - P2 | "HLX43 showed promising efficacy with a manageable safety profile in r/m NPC patients who had progressed after second-line or later chemotherapy and PD-(L)1 inhibitors. Further investigation is warranted. Efficacy and safety."

ADC • Clinical • Metastases • P2 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

A Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 Monotherapy or HLX43 in Combination With HLX07 Versus Docetaxel in Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2/3 | N=706 | Enrolling by invitation | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Monotherapy • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Researchers and clinicians from the Mount Sinai Tisch Cancer Center will present new research at the 2026 Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place Friday, May 29, through Tuesday, June 2, at McCormick Place in Chicago. (Mount Sinai Cancer)

P1 data • P3 data • Retrospective data • Trial status • Head and Neck Cancer • Non Small Cell Lung Cancer • Urothelial Cancer

HLX43-FIH101: A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=367 | Enrolling by invitation | Sponsor: Shanghai Henlius Biotech | Recruiting ➔ Enrolling by invitation

Enrollment status • First-in-human • Hepatocellular Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard Therapy (clinicaltrials.gov) - P2 | N=102 | Recruiting | Sponsor: Shanghai Henlius Biotech | N=72 ➔ 102

Enrollment change • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Shanghai Henlius Biotech has received implied approval from Japan’s Pharmaceuticals and Medical Devices Agency to start an international multicenter phase 2/3 clinical trial of HLX43, an anti-PD-L1 antibody-drug conjugate, as a monotherapy or in combination with the anti-EGFR antibody HLX07 for advanced squamous non-small cell lung cancer (TipRanks)

New P2/3 trial • Non Small Cell Lung Cancer

HLX43-NSCLC201: A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P2 | N=243 | Recruiting | Sponsor: Shanghai Henlius Biotech | N=41 ➔ 243

Enrollment change • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • MET • NTRK • ROS1

Henlius to Showcase Seven FIC/BIC Innovative Assets at AACR 2026, Highlighting Accelerated Early-Stage Innovation (Henlius Press Release) - "These include HLX43 (PD-L1 ADC), HLX316 (B7-H3×sialidase fusion protein), HLX3902 (STEAP1×CD3×CD28 trispecific T-cell engager)..."

Preclinical • Prostate Cancer

Preclinical studies reveal that protease-mediated payload release and immuno-oncology/immunomodulatory effects contribute to the antitumor activity of HLX43 (AACR 2026) - "It consists of HLX20, an engineered anti-PD-L1 humanized IgG1 antibody, conjugated via a protease-cleavable tripeptide linker to a potent camptothecin-derived topoisomerase I inhibitor (C24) at a drug-to-antibody ratio (DAR) of 8. Beyond direct cytotoxicity, HLX43 also remodels the TME, with in vivo studies showing increased infiltration of cytotoxic CD8+ T cells and reduced regulatory T cells (Tregs). These CD8+ T cells display enhanced effector function, including elevated IFNγ and Granzyme B expression.In summary, HLX43's convergent mechanisms—combining immune checkpoint inhibition, targeted cytotoxicity, and TME modulation—support its potential as both a monotherapy and in combination with other immuno-oncology agents, positioning HLX43 as a promising therapeutic candidate across diverse tumor types"

Immunomodulating • Immuno-oncology • IO biomarker • Preclinical • Oncology • CALR • CD8 • GZMB • IFNG • IL2

HLX43-CC201: A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant Tumors (clinicaltrials.gov) - P2 | N=190 | Recruiting | Sponsor: Shanghai Henlius Biotech | N=130 ➔ 190

Enrollment change • Cervical Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

A Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 Monotherapy or HLX43 in Combination With HLX07 Versus Docetaxel in Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2/3 | N=671 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

Monotherapy • New P2/3 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Phase II Clinical Study to Evaluate HLX43 in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=167 | Recruiting | Sponsor: Shanghai Henlius Biotech | N=90 ➔ 167 | Trial completion date: Jul 2028 ➔ Jan 2029

Enrollment change • Trial completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Breast Cancer. (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

Checkpoint inhibition • Monotherapy • New P2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P2 | N=38 | Recruiting | Sponsor: Shanghai Henlius Biotech | N=22 ➔ 38

Enrollment change • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • MET • NTRK • ROS1

HLX43-NSCLC201: Testing HLX43 in Advanced Lung Cancer (Non-Small Cell): A Global Safety and Effectiveness Study (clinicaltrialsregister.eu) - P1/2 | N=22 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech Inc.

New P1/2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • MET • NTRK • ROS1

A Phase II Study to Evaluate the Efficacy and Safety of HLX43 in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2