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    Henlius to Present Updated HLX43 TSCC Data and Seven Serplulimab Lung Cancer Studies at WCLC 2026, Addressing Unmet Needs

    2026-08-03

    The 2026 World Conference on Lung Cancer (WCLC) will take place in Seoul, South Korea, from September 12 to 15, 2026. 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).

    Among these presentations, one study has been selected for a Mini Oral session and two studies have been selected for Poster Tour sessions, underscoring Henlius’ innovation capabilities in lung cancer, TSCC, and other thoracic malignancies, as well as the broad clinical potential of its related products.


    HLX43: A Potential Best-in-Class PD-L1 ADC with Broad-Spectrum Anti-Tumor Activity and Immuno-Oncology Efficacy


    HLX43 is a novel PD-L1-targeting ADC, composed of a fully humanized anti-PD-L1 IgG1 antibody, a novel tripeptide linker and topoisomerase inhibitor payload. The drug to antibody ratio (DAR) is around 8. Its mechanism of action integrates targeted cytotoxic delivery and immune checkpoint activation through PD-L1/PD-1 blockade. Upon binding to PD-L1-expressing tumour cells, HLX43's cytotoxic payload can be delivered into tumour cells via dual mechanisms—First, the ADC undergoes receptor-mediated endocytosis, releasing the cytotoxic payload intracellularly via linker cleavage, and the payload further diffuses into neighbouring tumour cells via bystander effect, thereby blocking DNA replication and triggering tumour cell apoptosis. Meanwhile, the anti-PD-L1 antibody of HLX43 activates immune modulation and blocks immune checkpoints, driving synergistic antitumor efficacy.


    Early clinical data from its first-in-human study, along with multiple proof-of-concept results across solid tumours, have been presented at several international scientific conferences, including ASCO, WCLC etc., showing a favourable efficacy and safety profile across several solid tumor types, including non-small cell lung cancer (NSCLC), TSCC, gynecologic malignancies, and esophageal squamous cell carcinoma. Notably, HLX43 is the first PD-L1-targeting ADC globally to enter clinical development for thymic carcinoma. International multicenter clinical studies are currently underway in China, the United States, Japan, Australia, and other countries. In October 2025, HLX43 received Orphan Drug Designation from the U.S. FDA, highlighting its potential to address a significant unmet need in this rare and highly aggressive malignancy.


    Previously, Phase 1 data of HLX43 in advanced solid tumors, led by Professor Jie Wang of the Cancer Hospital, Chinese Academy of Medical Sciences, were first reported at the 2025 ASCO Annual Meeting, including results from the dose-escalation phase in solid tumors and the dose-expansion cohort in NSCLC. At WCLC 2026, results from the dose-expansion cohort in pretreated patients with advanced TSCC from this Phase 1 study will be presented during a Poster Tour session.

    Serplulimab: World’s First anti-PD-1 mAb for 1L SCLC, with Broad 1L LC Coverage


    Serplulimab is an innovative humanized anti-PD-1 mAb independently developed by Henlius. Leveraging its differentiated mechanism, serplulimab has achieved important advances in lung cancer and gastrointestinal malignancies. It is the world’s first approved anti-PD-1 mAb for first-line treatment of small cell lung cancer (SCLC), and the world’s first and only approved anti-PD-1 mAb for perioperative treatment of gastric cancer. To date, serplulimab has been approved in more than 50 countries and regions for multiple indications, including first-line treatment of squamous NSCLC (sqNSCLC), ES-SCLC, esophageal squamous cell carcinoma (ESCC), non-squamous NSCLC (nsqNSCLC), as well as perioperative treatment of gastric cancer. It has also been included in reimbursement or public healthcare payment systems in more than 10 countries, including the United Kingdom, Austria, Denmark, Germany, Ireland, Italy, Spain, and Sweden.


    In lung cancer, serplulimab has covered the full range of first-line treatment. Beyond currently approved indications, the international multicenter Phase 3 study of serplulimab in combination with chemotherapy and concurrent radiotherapy for first-line treatment of LS-SCLC has completed patient enrollment. Bridging studies in ES-SCLC being conducted in parallel in the United States and Japan have also completed enrollment.


    At WCLC 2026, a post hoc analysis and meta-analysis of serplulimab as first-line maintenance therapy for ES-SCLC, led by Professor Haifeng Liu of Jilin Cancer Hospital, will be presented for the first time, further reinforcing serplulimab’s leadership in the first-line treatment of ES-SCLC. In addition, several investigator-initiated trials (IITs) will also be presented, including a study of neoadjuvant serplulimab in LS-SCLC led by Professor Wenzhao Zhong of Guangdong Provincial People’s Hospital, Southern Medical University, which has been selected for a Mini Oral session. These studies further expand the clinical exploration of serplulimab into frontline treatment of LS-SCLC, enrich combination treatment strategies in both first- and second-line ES-SCLC, and provide preliminary evidence supporting the potential of serplulimab plus chemotherapy as first-line treatment for LCNEC.