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.
Details of the release are as follows:
PD-L1 ADC HLX43
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 mechanisms of action integrates targeted cytotoxic delivery and immune checkpoint activation through PD-L1/PD-1 blockade. Upon binding to PD-L1-expressing tumor cells, HLX43's cytotoxic payload can be delivered into tumor 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 neighboring tumor cells via bystander effect, thereby blocking DNA replication and triggering tumor cell apoptosis. Meanwhile, the anti-PD-L1 antibody of HLX43 activates immune modulation and blocks immune checkpoints, driving synergistic antitumor efficacy. At WCLC 2025, HLX43 stands out among multiple ADC molecules, with its updated phase 1 clinical data selected for poster tour session.(only 5% were chosen for this session from over 1500 posters)
The results from the phase 1 clinical trial of HLX43 has been first released at the 2025 ASCO Annual Meeting, demonstrating manageable safety profile and encouraging efficacy in various solid tumors especially in patients with NSCLC, including squamous and non-squamous NSCLC patients (sqNSCLC and nsqNSCLC), patients with or without EGFR mutation, patients with or without brain/liver metastasis, and PD-L1 positive or negative patients. To date, HLX43 has been approved by the China NMPA, the U.S. FDA, Australia TGA and Japan's PMDA to initiate phase 2 multi-regional clinical trial in patients with advanced non-small cell lung cancer (NSCLC). Additionally, the first patient dosing has been completed in China.
HLX43-FIH101
Title: Safety, Tolerability and Preliminary Efficacy of Anti-PD-L1 ADC HLX43 in Advanced/Metastatic Solid Tumors: A Phase I study
Form: Poster Tour
Session: PT2.10-Metastatic Non-small Cell Lung Cancer - Antibody-Drug Conjugate and Cytotoxic Therapy
Abstract Number: 1459
Leading PI: Jie Wang, Cancer Hospital Chinese Academyof Medical Sciences
Time: Sep 8, 2025 2:31 PM-2:39 PM (CEST)
HANSIZHUANG（serplulimab, anti-PD-1 mAb）
HANSIZHUANG is the world’s first anti-PD-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer. It has been approved in nearly 40 countries and regions, including China, the UK, Germany, Singapore, and India. Henlius continues to expand the layout of HANSIZHUANG in the field of lung cancer. Up to date, it has been approved for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). In additon, the company is conducting a phase 3 international multi-centre clinical trial of HANSIZHUANG combined with chemotherapy and radiotherapy for limited-stage SCLC (LS-SCLC).
The product was granted orphan drug designations from the FDA, the EC and Swissmedic for the treatment of SCLC, as well as from the Korean Ministry of Food and Drug Safety (MFDS) for the treatment of ES-SCLC. Its bridging head-to-head trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way. Focusing on lung cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted to explore the therapeutic potential of immunotherapy in a wide range of populations, including the perioperative setting for patients with NSCLC and patients with brain metastases.
HLX10-002-NSCLC301
Title: ASTRUM-002: First-Line Serplulimab Plus Chemotherapy With or Without HLX04 in Advanced Nonsquamous Non-small Cell Lung Cancer
Form: Oral
Session: OA05-lmmunotherapy for Special Populations
Abstract Number: 1454
Leading PI: Yuankai Shi, Cancer Hospital Chinese Academy of Medical Sciences
Time: Sunday Sep 7, 2025 4:46 PM-4:56 PM (CEST)
HLX07HLX10-sqNSCLC201
Title: First-line HLX07 plus serplulimab with or without chemotherapy in squamous non-small cell lung cancer: a phase 2 study
Form: Poster
Session: P3.12-Metastatic Non-small Cell Lung Cancer - Targeted Therapy
Abstract Number: 1467
Leading PI: Yilong Wu, Guangdong Provincial People's Hospital
Time: Sep 9, 2025 10:00 AM-11:30 AM (CEST)
Title: Phase II Trial of Serplulimab Plus Bevacizumab and Chemotherapy for Treatment-Naive Non-Squamous NSCLC with Brain Metastases(SUPER BRAIN)
Form: Mini Oral
Session: MA10-Longer Follow Up and New IO Combinations
Abstract Number: 2266
Leading PI: Likun Chen, Sun Yat-Sen University Cancer Center
Time: Sep 9,2025 1:02 PM-1:07 PM (CEST)
Title: Minimal Residual Disease Dynamic Monitoring in First-Line Serplulimab Plus Chemotherapy in Treatment of Extensive-Stage Small Cell Lung Cancer
Form: Mini Oral
Session: MA03 New Advances in circulating Biomarkers
Abstract Number: 1217
Leading PI: Kewei Ma, Jilin University the First Hospital
Time: Sep 7,2025 3:17 PM - 3:22 PM (CEST)
Title: Bevacizumab Plus Serplulimab and Chemotherapy for EGFR-TKI-Resistant Non-squamous Non-small-cell Lung Cancer: A Phase 2 Study
Form: Poster
Session: P1.11-Metastatic Non-small Cell Lung Cancer -lmmunotherapy
Abstract Number: 2217
Leading PI: Qiming Wang, Henan Cancer Hospital
Time: Sep 7,2025 10:30 AM-12:00 AM (CEST)
Title: Multi-Cycle Low-Dose Radiotherapy Reshapes lmmunochemotherapy forES-SCLC: The SPUR Phase II Trial
Form: Poster Tour
Session: PT2.13 - Small Cell Lung Cancer and Neuroendocrine Tumors
Abstract Number: 2316
Leading PI: You Lu, West China School of Medicine/West China Hospital of Sichuan University
Time: Sep 8, 2025 2:23 PM-2:31 PM (CEST)
Title: Serplulimab in Neoadjuvant Therapy for Locally Advanced Non-Small Cell Lung Cancer: A Prospective Single-Arm Study
Form: Poster
Session: P2.08 - Local-Regional Non-small Cell Lung Cancer
Abstract Number: 1954
Leading PI: Jian Zeng, Zhejiang Cancer Hospital
Time: Sep 8, 2025 10:30 AM-12:00 AM (CEST)
Title: First-Line Immunochemotherapy in ES-SCLC Patients with ECOG PS ≥2: Real-World Evidence from the ASTRUM-005R Trial
Form: Poster
Session: P3.13-Small Cell Lung Cancer and Neuroendocrine Tumors
Abstract Number: 1534
Leading PI: Lin Wu, Hunan Cancer Hospital | Chengping Hu, Xiangya Hospital of Central South University
Time: Sep 9,2025 10:00 AM-11:30 AM (CEST)
Title: Meta-Analysis of First-Line Immunochemotherapy in ES-SCLC: Does ECOG PS ≥2 Affect Survival Outcomes?
Form: E-Poster
Abstract Number: 1885
Leading PI: Xinmin Yu, Zhejiang Cancer Hospital
