HLX43 / Fosun Pharma, MediLink - LARVOL DELTA

A phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX43 (anti-PD-L1 ADC) in patients with advanced/metastatic solid tumors. (ASCO 2025) - P1 | "Clinical Trial Registration Number: NCT06115642 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • P1 data • PK/PD data • Oncology • Solid Tumor

APhase 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

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

A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=105 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

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

THE FIRST PATIENT HAS BEEN DOSED IN A PHASE 1B/2 CLINICAL TRIAL OF HLX43 FOR INJECTION (ANTIBODY-DRUG CONJUGATE TARGETING PD-L1 WITH NOVEL DNA TOPOISOMERASE I INHIBITOR) IN COMBINATION WITH HANSIZHUANG (SERPLULIMAB INJECTION) FOR THE TREATMENT OF PATIENTS WITH ADVANCED/METASTATIC SOLID TUMOURS IN MAINLAND CHINA (HKEXnews) - "The board of directors of the Company (the 'Board') is pleased to announce that, recently, the first patient has been dosed in a phase 1b/2 clinical trial of HLX43 for injection (antibody-drug conjugate targeting PD-L1 with novel DNA topoisomerase I inhibitor) ('HLX43') in combination with HANSIZHUANG (serplulimab injection) ('HANSIZHUANG') for the treatment of patients with advanced/metastatic solid tumours in mainland China....This phase 1b/2 study aims to evaluate the safety, tolerability, and efficacy of HLX43 in combination with HANSIZHUANG in patients with advanced/metastatic solid tumours."

Trial status • Solid Tumor

A Phase II Clinical Study to Evaluate HLX43 in Patients With Locally Advanced or Metastatic HCC Failed or Intolerance to Standard Therapy (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor

HLX43-CC201: A Phase II Clinical Study to Evaluate HLX43 in Patients with Recurrent/Metastatic CC Failed or Intolerance to Standard Therapy (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • Cervical Cancer • Oncology • Solid Tumor

A Phase II Clinical Study to Evaluate HLX43 in Subjects with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Shanghai Henlius Biotech

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination with Serplulimab in Patients with Advanced/metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=105 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • 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=90 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P2 trial • Head and Neck Cancer • Nasopharyngeal Carcinoma • 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=60 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

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

First Subject Dosed for a Phase 2 Clinical Trial of Henlius’ PD-L1-Targeting ADC HLX43 (Henlius Press Release) - "Recently, Shanghai Henlius Biotech...announced that the first subject has been dosed for a phase 2 clinical trial of HLX43 for Injection (HLX43-ESCC201), the novel Programmed Death-Ligand 1 (PD-L1)-targeting antibody-drug conjugate (ADC) that developed by the company based on the collaboration with MediLink Therapeutics, for the treatment of patients with recurrent/metastatic esophageal squamous cell carcinoma (ESCC)."

Trial status • Esophageal Squamous Cell Carcinoma

A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard Therapy (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic CC Failed or Intolerance to Standard Therapy (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P2 trial • Cervical Cancer • Oncology • Solid Tumor

A Phase II Clinical Study to Evaluate HLX43 in Patients With Locally Advanced or Metastatic HCC Failed or Intolerance to Standard Therapy (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

Metastases • New P2 trial • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor

Henlius Receives IND Approval from NMPA for a Phase 1b/2 Clinical Trial of Its Novel PD-L1-Targeting ADC HLX43 (Henlius Press Release) - "Shanghai Henlius Biotech...announced that the investigational new drug (IND) application for a phase 1b/2 clinical trial 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 China National Medical Products Administration (NMPA), for monotherapy or combination therapy to treat patients with advance/metastatic solid tumours."

New P1/2 trial • Solid Tumor

Henlius to Make Its Debut at the World ADC Asia 2024 (Henlius Press Release) - "From June 25-27, 2024, World ADC Asia 2024 will be held in Incheon, South Korea. Henlius will make a big debut at the conference and showcase its multiple ADC (Antibody Drug Conjugate) assets as well as self-developed ADC technical platform....During the World ADC Asia 2024, Dr. Yongqiang, Shan, General manager of Henlius Global Innovation Centerwill present as a speaker on the company’s latest innovative practice and achievements in ADC area. Meanwhile, the updated data of two potential first/best-in-class ADC products, HLX42, the novel EGFR-targeting ADC, and HLX43, the PD-L1 targeting ADC, will be published as posters at the conference."

Clinical data • Solid Tumor

Henlius to Showcase at BIO 2024 (Henlius Press Release) - "Henlius, along with its wholly-owned subsidiary, Aton Biotech, a biologics CDMO will showcase a wide range of innovative research and development accomplishments for conference attendees. As an innovative global biopharma company, Henlius has always been guided by clinical needs to build up a high-quality, affordable and differentiated pipeline to effectively meet the needs of patients and the market...HLX22, has been approved by the FDA. Besides, the company is promoting the clinical development of two potential first/best-in-class products, HLX42 (EGFR ADC) and HLX43 (PD-L1 ADC)....Henlius is determined to offer high-quality, affordable, and innovative biologic medicines for patients worldwide, focuses on game-changing innovations, and aggressively pursues anti-tumour research and international collaboration. We warmly invite you to visit and connect with us at booth #1719 at San Diego Convention Center."

Clinical • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • DDX5

Henlius Receives the FDA IND Approval for Its PD-L1-Targeting ADC Candidate HLX43 (Henlius Press Release) - "Shanghai Henlius Biotech...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."

IND • Solid Tumor

First Subject Dosed for Phase 1 Clinical Trial of Henlius’ ADC Candidate HLX43 (Henlius Press Release) - "Shanghai Henlius Biotech...announced that the first subject was dosed for a phase 1 clinical trial of HLX43, a novel PD-L1-targeting antibody-drug conjugate (ADC), for the treatment of advanced/metastatic solid tumours. HLX43 was developed by the company based on the collaboration with MediLink Therapeutics and is the first PD-L1-targeting ADC in China to enter a clinical trial."

Trial status • Solid Tumor

Preclinical activity of HLX43, a PD-L1-targeting ADC, in multiple PD-1/PD-L1 refractory/resistant models (ESMO 2023) - "Conclusions HLX43 showed promising efficacy and tolerability in preclinical assessments. It may offer a novel treatment for PD-1/PD-L1 inhibitor R/R cancers like NSCLC, HNSCC, ESCC, MEL, and OVC."

IO biomarker • Preclinical • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-1

A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

Metastases • New P1 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • DDX5

Henlius Announces NMPA Approvals of Two ADC Candidates for IND (PRNewswire-Asia) - "Shanghai Henlius Biotech...announced that 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), for the treatment of advance/metastatic solid tumours. The two products were developed by the company based on the collaboration with MediLink Therapeutics and become first ADC candidates of Henlius that are entering into clinical development."

New trial • Solid Tumor

Results From the Preclinical Study of HLX43, a Potential FIC PD-L1-Targeting ADC Released at 2023 ESMO (Henlius Press Release) - "Shanghai Henlius Biotech...announced that the results from the preclinical study of HLX43, the novel PD-L1- targeting ADC which was developed by the company based on the collaboration with MediLink Therapeutics was released as poster at the 2023 European Society of Medical Oncology (ESMO) Congress....In in vivo efficacy studies, HLX43 induced tumour regression in multiple PD-L1-positive CDX models and PDX models, and was well tolerated, with no changes in body weight compared to control animals across all dosing groups."

Preclinical • Oncology