HLX43 / Fosun Pharma, MediLink - LARVOL DELTA

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

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 | "Funded by Shanghai Henlius Biotech, Inc. Clinical Trial Registration Number: NCT06769113 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

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

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

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

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

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ADC) in recurrent/metastatic esophageal squamous cell carcinoma (ESCC): a multicentre, randomised phase 2 study [WITHDRAWN] (ESMO Asia 2025) - No abstract available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

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

Enrollment open • Colorectal Cancer • Oncology • Solid Tumor

Strengthening Original Innovation Capability, Building a High-Value Pipeline Portfolio (PRNewswire) - "In terms of R&D investment, in the first three quarters of 2025, Fosun Pharma's R&D investment amounted to RMB3,998 million in total, up by 2.12% period-on-period. In particular, R&D expenses amounted to RMB2,730 million. In the third quarter of 2025, R&D expenses amounted to RMB1,013 million, up by 28.81% period-on-period. The investment primarily focused on cutting-edge technology platforms such as radiopharmaceuticals and cell therapy, as well as global multicenter clinical trials of high-value pipelines, including HLX22 (recombinant humanized anti-HER2 monoclonal antibody injection) and HLX43 (PD-L1-targeted antibody-drug conjugate)."

Commercial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Breast Cancer • Hormone Receptor Positive Breast Cancer • Thymic Epithelial Tumor

Henlius Biopharmaceuticals…announced that its wholly-owned subsidiary, Henlius USA Inc., recently received a letter from the U.S. Food and Drug Administration (FDA) granting Orphan Drug Designation to HLX43 (antibody-drug conjugate targeting PD-L1) for injection for the treatment of thymic epithelial tumors (TETs). [Google translation] (iis.aastocks.com)

Orphan drug • Thymic Epithelial Tumor

APPLICATION FOR PHASE 1B/2 CLINICAL TRIAL OF HLX43 FOR INJECTION (AN ANTI-PD-L1 ANTIBODY-DRUG CONJUGATE) IN COMBINATION WITH HLX07 (RECOMBINANT ANTI-EGFR HUMANISED MONOCLONAL ANTIBODY INJECTION) FOR THE TREATMENT OF ADVANCED/METASTATIC SOLID TUMOURS WAS APPROVED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION (HKEXnews)

New P1/2 trial • Solid Tumor

Safety, Tolerability and Preliminary Efficacy of Anti-PD-L1 ADC HLX43 in Advanced/Metastatic Solid Tumors: A Phase I Study (IASLC-WCLC 2025) - "Conclusions : HLX43 demonstrated a manageable safety profile and preliminary antitumor activity in patients with advanced NSCLC who were refractory to standard therapies, including those who had progressed after treatment with PD-(L)1 inhibitors. Enrollment in the Phase Ib expansion cohort is ongoing."

Clinical • Metastases • P1 data • Anemia • Carcinosarcoma • Cervical Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Febrile Neutropenia • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Nasopharyngeal Carcinoma • Neutropenia • Non Small Cell Lung Cancer • Oncology • Sarcoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Uterine Cancer • EGFR

Safety, Tolerability and Preliminary Efficacy of Anti-PD-L1 ADC HLX43 in Advanced/Metastatic Solid Tumors: A Phase I Study (IASLC-WCLC 2025) - "Conclusions : HLX43 demonstrated a manageable safety profile and preliminary antitumor activity in patients with advanced NSCLC who were refractory to standard therapies, including those who had progressed after treatment with PD-(L)1 inhibitors. Enrollment in the Phase Ib expansion cohort is ongoing."

Clinical • Metastases • P1 data • Anemia • Carcinosarcoma • Cervical Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Febrile Neutropenia • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Nasopharyngeal Carcinoma • Neutropenia • Non Small Cell Lung Cancer • Oncology • Sarcoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Uterine Cancer • EGFR

FIRST PATIENT IN AUSTRALIA HAS BEEN DOSED IN AN INTERNATIONAL MULTICENTRE PHASE 2 CLINICAL STUDY OF HLX43 FOR INJECTION (AN ANTI-PD-L1 ANTIBODY-DRUG CONJUGATE) FOR THE TREATMENT OF ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) (HKEXnews) - "This is an open-label, multicentre, international phase 2 clinical study to evaluate HLX43 in patients with advanced non-small cell lung cancer (NSCLC)."

Trial status • Non Small Cell Lung 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 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

FIRST PATIENT IN THE UNITED STATES HAS BEEN DOSED IN AN INTERNATIONAL MULTI-CENTER PHASE 2 CLINICAL STUDY OF HLX43 FOR INJECTION (AN ANTI-PD-L1 ANTIBODY-DRUG CONJUGATE) FOR THE TREATMENT OF ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) (HKEXnews) - "This phase 2 clinical study is also ongoing in mainland China...and the Company proposes to commence clinical trials in Australia, Japan and other countries when the conditions are met."

Trial status • Non Small Cell Lung Cancer

HLX43 FOR INJECTION (AN ANTI-PD-L1 ANTIBODY-DRUG CONJUGATE) HAS BEEN APPROVED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) FOR THE PHASE 1 CLINICAL TRIAL FOR THE TREATMENT OF THYMIC CARCINOMA (TC) (HKEXnews) - "The board of directors (the 'Board') of the Company is pleased to announce that, recently, HLX43 for injection (an anti-PD-L1 antibody-drug conjugate) ('HLX43') has been approved by the United States Food and Drug Administration (FDA) to initiate a phase 1 clinical trial for the treatment of thymic carcinoma (TC), enabling the proceeding of subsequent clinical study activities. The Company proposes to commence such clinical study for the treatment of thymic carcinoma (TC) in Australia, Japan, the United States, and other countries when the conditions are met."

IND • New P1 trial • Thymic Carcinoma

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

New P2 trial • Colorectal Cancer • Oncology • Solid Tumor

Henlius to Present Latest Results on ADC and IO Therapies in Lung Cancer at 2025 WCLC (Henlius Press Release) - "2025 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer(IASLC) will be held from September 6-9 in Barcelona, Spain‌. At the conference, Henlius will showcase 10 latest results from its innovative products on lung cancer, which includes 3 oral presentations and 2 poster tours, covering updated phase 1 clinical data‌ for PD-L1 ADC HLX43, the results(first release) from ASTRUM-002, a phase 3 clinical trial of serplulimab (anti-PD-1 monoclonal antibody) in the first line treatment of advanced non-squamous non small cell lung cancer (NSCLC) as oral presentation, along with further research findings on serplulimab in lung cancer, making it the Chinese biopharmaceautical with most oral presentations."

Clinical data • Lung Non-Squamous Non-Small Cell Cancer • Small Cell Lung Cancer

First Subject Dosed for a Phase 2 MRCT of Henlius’ PD-L1-Targeting ADC HLX43 for the Treatment of NSCLC (Henlius Press Release) - "Shanghai Henlius Biotech...announced that the first subject has been dosed for HLX43-NSCLC201, a phase 2 international muticenter clinical trial of HLX43, 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 advanced non-small cell lung cancer (NSCLC)....HLX43 is the first PD-L1 ADC progressed to phase 2 clinical trial development globally."

Trial status • Non Small Cell Lung Cancer

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 | "HLX43 was well tolerated with no new safety signals across different dose and exhibited encouraging preliminary efficacy in patients with advanced solid tumors, including those with NSCLC, who had failed standard therapies, which warrants further investigation."

Clinical • Metastases • P1 data • PK/PD data • Carcinosarcoma • Cervical Cancer • Febrile Neutropenia • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Nasopharyngeal Carcinoma • Neutropenia • Non Small Cell Lung Cancer • Oncology • Sarcoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Thymic Carcinoma • Thymus Cancer • Uterine Cancer • HER-2

Results from the Phase 1 Clinical Trial of Henlius PD-L1 ADC HLX43 Released at 2025 ASCO Annual Meeting (Henlius Press Release) - P1 | N=174 | NCT06115642 | Sponsor: Shanghai Henlius Biotech | "As of the data cut-off date Mar 28, 2025, a total of 21 patients were enrolled in phase 1a to receive HLX43 at 0.5 mg/kg (n=3), 1 mg/kg (n=3), 2 mg/kg (n=3), 2.5 mg/kg (n=3), 3 mg/kg (n=3), or 4 mg/kg (n=6)....Investigator-assessed ORR for the phase 1a cohorts was 36.8%; 75% patients with thymic squamous cell carcinoma achieved partial response (ORR = 75%, 3/4). Investigator-evaluated ORR for the phase 1b 2.0 mg/kg cohort was 38.1%. ORR in the squamous NSCLC patients was 40%. Notably, the disease control rate (DCR) in NSCLC patients with brain metastasis reached 100%....Median progression-free survival (PFS) was 4.2 months for the phase 1a cohorts and 5.4 months for phase 1b 2.0 mg/kg cohort. Median overall survival (OS) was 8.9 months and not reached, respectively."

P1 data • Non Small Cell Lung Cancer