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

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

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

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

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

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 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

Henlius Initiates a Phase 2/3 MRCT of Its Pan-Tumor PD-L1 ADC HLX43 for sqNSCLC in the US (Henlius Press Release) - "The study is planned to proceed to the subsequent Phase 3 stage following the completion of the Phase 2 stage and further discussions with the FDA. The Phase 3 stage is expected to serve as the first pivotal registration study for HLX43 and represents a significant milestone for HLX43 in the field of NSCLC."

Trial status • Lung Non-Small Cell Squamous Cancer

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

Shanghai Henlius Biotech…announced that the first patient has been dosed in China in a Phase 1b/2 trial (HLX43-mCRC202), for the company's innovative programmed death-ligand 1 (PD-L1) antibody-drug conjugate (ADC), HLX43, in combination with serplulimab…or independently developed recombinant anti-EGFR mAb HLX07 in patients with advanced or metastatic colorectal cancer (mCRC) (Henlius Press Release)

Trial status • Colorectal Cancer

Shanghai Henlius Biotech, Inc…announced that the investigational new drug (IND) application for a clinical trial of HLX43, the innovative programmed death-ligand 1 (PD-L1) targeting antibody-drug conjugate (ADC) (Henlius Press Release) - "...in combination with the company's anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab) and independently developed innovative anti-EGFR mAb HLX07 has been approved by the China National Medical Products Administration (NMPA), for the treatment of advanced solid tumors."

New trial • Solid Tumor

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 Press Release) - "Among all of the 33 response-evaluable patients, promising efficacy results were observed，with an ORR of 30.3% and a DCR of 81.8%. Notably, in the 3 mg/kg group(n=13), the ORR was 61.5%( 8 partial response) and DCR was 100.0%, with a confirmed ORR (cORR) of 38.5%.In this dose group，patients with a PD-L1 CPS ≥ 1 (n=10) had an ORR of 60.0% and a DCR of 100%, compared with an ORR of 50.0% and a DCR of 100% in those with a CPS < 1 (n=2). HLX43 conferred promising efficacy regardless of PD-L1 expression. Large-scale randomized studies are required for definitive conclusion."

P2 data • Esophageal Squamous Cell Carcinoma

A Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer (clinicaltrials.gov) - P1/2 | N=126 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P1/2 trial • Colon Adenocarcinoma • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor • BRAF • MSI

A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

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

HLX43 - PD-L1 ADC ('Pipeline-in-a-Pill') with High-Efficacy, a Favourable Safety Profile and I/O Effects, Potential BIC (PRNewswire) - "By the end of 2026, Henlius anticipates to: (i) Initiate three global pivotal trials in second-line EGFR wild-type nsqNSCLC, third-line and later sqNSCLC, and second-line sqNSCLC; (ii) Launch two PoC trials in HR-positive and triple-negative breast cancer; (iii) Present clinical data across ESCC, NSCLC, NPC, cervical and ovarian cancers at major congresses (ESCC data were recently presented at ASCO GI); (iv) Complete PoC readouts of combination trials with serplulimab ± HLX07 in NSCLC, SCLC and mCRC."

Clinical data • New trial • Cervical Cancer • Colorectal Cancer • Esophageal Squamous Cell Carcinoma • Hormone Receptor Positive Breast Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Nasopharyngeal Carcinoma • Ovarian Cancer • Small Cell Lung Cancer • Triple Negative Breast Cancer

A multicenter, randomized phase 2 study evaluating the efficacy and safety of HLX43 (an anti-PD-L1 ADC) in recurrent/metastatic esophageal squamous cell carcinoma. (ASCO-GI 2026) - P2 | "HLX43 conferred promising efficacy, particularly at 3 mg/kg dose, along with a manageable safety profile in patients with previously treated recurrent/metastatic ESCC. Further investigation is warranted."

Clinical • IO biomarker • Metastases • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology

A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Pancreatic Cancer (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P2 trial • Oncology • Pancreatic Cancer • Solid Tumor

A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=340 | Recruiting | Sponsor: Shanghai Henlius Biotech | N=174 ➔ 340

Enrollment change • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • DDX5

A Phase II Study to Evaluate the Efficacy and Safety of HLX43 in Combination With Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Efficacy and safety of HLX43 (an anti-PD-L1 ADC) in recurrent/metastatic cervical cancer (CC): A randomised, multicentre, phase II study (ESMO Asia 2025) - P2 | "Background: Tisotumab vedotin (a tissue factor-targeting ADC) has demonstrated efficacy in recurrent/advanced cervical cancer (CC) and was approved for this indication. HLX43, particularly at 3 mg/kg, exhibited promising efficacy and manageable safety in patients with previously treated recurrent/metastatic CC. Further investigation of HLX43 is warranted."

Clinical • IO biomarker • Metastases • P2 data • Cervical Cancer • Oncology • Solid Tumor • PD-L1

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=130 | Recruiting | Sponsor: Shanghai Henlius Biotech | N=60 ➔ 130

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

Efficacy and safety of HLX43 (an anti-PD-L1 ADC) in recurrent/metastatic esophageal squamous cell carcinoma (ESCC): a multicentre, randomised phase 2 study [WITHDRAWN] (ESMO Asia 2025) - No abstract available

Clinical • Metastases • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

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

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Phase II Study to Evaluate HLX43 in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma Failed or Intolerance to Second-line Therapy (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Henlius to Present Diverse Solid Tumor Pipeline at 2025 ESMO Asia: Phase 2 Cervical Cancer Data for PD-L1 ADC HLX43 Featured in Proffered Paper (Henlius Press Release)

Clinical data • Cervical Cancer

Phase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor