The 2025 European Society for Medical Oncology Asia (ESMO Asia 2025) Congress will be held in Singapore from December 5–7, 2025. At the congress, 10 latest research findings from four core assets— PD-L1 ADC HLX43, anti-PD-1 mAb serplulimab (trade name: Hetronifly® in Europe), pertuzumab biosimilar HLX11 (trade name: POHERDY® in the U.S.), and oral lasofoxifene HLX78—will be presented in Proffered Paper, mini orals, and posters sessions, showcasing the company's diversified pipeline and cutting-edge exploration in oncology. A key highlight will be the first presentation of Phase 2 clinical data for the broad-spectrum anti-tumor ADC HLX43 in cervical cancer.
PD-L1 ADC HLX43: Potential Best-in-Class and Best-in-Disease ADC with Broad-Spectrum Anti-Tumor Activity and IO Efficacy
– Presented as Proffered Paper at International Conference
HLX43 is a potential best-in-class as well best-in-disease broad-spectrum anti-tumor ADC candidate targeting PD-L1, which exhibits dual mechanisms integrating immune checkpoint blockade and payload-mediated cytotoxicity. Preclinical data has shown that, HLX43 has good anti-tumor effects and a favorable tolerability profile in NSCLC, cervical cancer (CC), esophageal squamous cell carcinoma (ESCC), and other tumor types that were PD-1/L1 mAb-resistant. The results from the phase 1 clinical trial of HLX43 was first released at the 2025 ASCO Annual Meeting and 2025 WCLC, 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 metastasis, and PD-L1 positive or negative patients. Meanwhile, as the first PD-L1 ADC developed for thymic carcinoma globally, its international multi-center clinical trials are concurrently advancing in China, the U.S., Japan, Australia, etc. In October 2025, based on the compelling preliminary efficacy data from later-line settings in thymic carcinoma (TC), the U.S. FDA granted Orphan Drug Designation (ODD) to HLX43 for the treatment of Thymic epithelial tumors (TETs), highlighting the drug's potential to address the significant unmet need for ADC therapies in this disease. In addition to NSCLC and TC, Henlius is actively exploring HLX43's therapeutic potential in various solid tumors. The company has initiated 10 clinical studies for HLX43, covering CC, ESCC, head and neck squamous cell carcinoma (HNSCC), nasopharyngeal cancer (NPC), colorectal cancer (CRC), gastric or gastroesophageal junction (G/GEJ) adenocarcinoma and hepatocellular carcinoma (HCC). To date, over 400 patients had been globally enrolled for HLX43, including more than 170 patients with NSCLC.
#Gynaecological Cancer
Title: Efficacy and Safety of HLX43 (an anti-PD-L1 ADC) in Recurrent/Metastatic Cervical Cancer (CC): a Randomised, Multicentre, Phase 2 Study
Form: Proffered Paper
Presentation Number: 602O
Session: Proffered Paper session: Gynaecological cancers
Leading PI: Jinming Yu, Shandong Cancer Hospital
Time: Dec 5, 2025 2:55 PM-3:05 PM
Serplulimab: World’s First Anti-PD-1 mAb for 1L Treatment of SCLC & first perioperative gastric cancer regimen replacing adjuvant chemotherapy with PD-1 monotherapy—Multiple Real-World Studies to Release, Validating Its Broad Clinical Value
Serplulimab is the world’s first anti-PD-1 monoclonal antibody(mAb) approved for the first-line treatment of small cell lung cancer (SCLC), and the first perioperative gastric cancer regimen replacing adjuvant chemotherapy with PD-1 monotherapy. Since its initial approval in 2022, serplulimab was officially approved for marketing in China and is currently indicated 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 (nsqNSCLC). To date，it has been approved in 40 countries and regions including China, the U.K., Germany, Singapore and India, covering nearly half of the global population and accelerating global accessibility. Serplulimab demonstrates unique advantages in treating various solid tumors via its differentiated mechanism, especially achieving groundbreaking progress in both lung and gastric cancers. The results of 4 pivotal trials of serplulimab were published in the Journal of the American Medical Association (JAMA), Nature Medicine, Cancer Cell and British Journal of Cancer, respectively. It has also received orphan drug designations granted by the US FDA, the European Commission, Swissmedic and Korea MFDS.
#Lung Cancer
Title:Efficacy and Safety of Neoadjuvant Serplulimab in Locally Advanced Driver Gene-Negative NSCLC: A Multicenter Real-World Study
Form: Poster
Presentation Number: 947P
Session: Poster Display session
Leading PI: Nanlong Lin& Jianbo Lin, The First Affiliated Hospital of Fujian Medical University
Time: Dec 5, 2025 5:15 PM-6:15 PM
Title: Real-World Study of Serplulimab as First-Line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer
Form: ePoster
Presentation Number: 965eP
Session: Poster Display session
Leading PI: Jing Zhou, The First Affiliated Hospital of Nanchang University
Time: Dec 5, 2025 5:15 PM-6:15 PM
#Gastrointestinal Tumors
Title: A Multicenter Randomized Trial of Serplulimab After mFOLFOX6 and HLX04 Induction in First-Line Treatment of MSS Metastatic Colorectal Cancer
Form: Poster
Presentation Number: 220P
Session: Poster Display session
Leading PI: Zhangfa Song, Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Time: Dec 5, 2025 5:15 PM-6:15 PM
Title: Updated outcome and ctDNA Profiling in Advanced HER2+ Gastric Cancer Patients Treated with DOS plus Serplulimab and Trastuzumab: A Phase II Multicenter Trial
Form: Poster
Presentation Number: 314P
Session: Poster Display session
Leading PI: Yan Wang, Zhongshan Hospital, Fudan University
Time: Dec 5, 2025 5:15 PM-6:15 PM
Title: Identification of Potential Immune Biomarkers associating to Clinical Benefit from Intensive Chemotherapy Combined with Serplulimab and Trastuzumab in Advanced HER2+ Gastric Cancer: A Post-hoc Analysis of the ASTRUM Study
Form: Poster
Presentation Number: 315P
Session: Poster Display session
Leading PI: Luoyan Ai, Zhongshan Hospital, Fudan University
Time: Dec 5, 2025 5:15 PM-6:15 PM
#Squamous Cell Carcinoma
Title: Induction Serplulimab and Cetuximab Combined with Chemotherapy Followed by Radiotherapy for Unresectable Locally Advanced HNSCC: A Single-arm, Prospective, Phase II Study
Form: Poster
Presentation Number: 687P
Session: Poster Display session
Leading PI: Changlin Zou, The First Affliated Hospital of Wenzhou Medical University
Time: Dec 5, 2025 5:15 PM-6:15 PM
#Gynaecological Cancer
Title: Serplulimab in Advanced, Recurrent, or Metastatic Cervical Cancer: A Prospective Multicenter Real-World Study
Form: Poster
Presentation Number: 633P
Session: Poster Display session
Leading PI: Beihua Kong, Qilu Hospital of Shandong University
Time: Dec 5, 2025 5:15 PM-6:15 PM
Title: Serplulimab in Advanced, Recurrent, or Metastatic Cervical Cancer: A Prospective Multicenter Real-World Study
Form: Poster
Presentation Number: 633P
Session: Poster Display session
Leading PI: Beihua Kong, Qilu Hospital of Shandong University
Time: Dec 5, 2025 5:15 PM-6:15 PM
HLX11: First Approved Pertuzumab Biosimilar in the US & First Chinese-Developed Pertuzumab Approved Overseas—Mini Oral Presentation: Pivotal Phase 3 Clinical Equivalence Data Empowers Global Drug Accessibility
HLX11 is a pertuzumab biosimilar independently developed by Henlius in compliance with the guidelines for biosimilar drug development of China, the EU, and the U.S. Its potential indications include adjuvant therapy and neoadjuvant therapy for HER2-positive early breast cancer, and treatment of HER2-positive metastatic breast cancer. In November 2025, HLX11 ( U.S. trade name: POHERDY® ) was approved by the U.S. FDA as an interchangeable biosimilar to PERJETA (pertuzumab), making it the first approved pertuzumab biosimilar in the U.S. The marketing applications are under review in the EU, Canada and China.
#Breast Cancer
Title: Neoadjuvant HLX11 versus European Union (EU)-sourced pertuzumab in human epidermal growth factor receptor 2 (HER2)-positive, hormone receptor (HR)-negative early or locally advanced, breast cancer (BC): A double-blind, randomised phase 3 equivalence study
Form: Mini Oral
Presentation Number: 65MO
Session: Mini Oral session: Breast cancer
Leading PI: Qiang Liu, Sun Yai-Sen Memorial Hospital Sun Yai-Sen University
Time: Dec 6, 2025 3:17 PM-3:22 PM
HLX78（Oral Lasofoxifene）
HLX78 (lasofoxifene) is a clinical-stage oral selective estrogen receptor modulator (SERM) licensed by Henlius from Sermonix Pharmaceuticals, Inc. It has demonstrated robust target engagement in ER+/HER2- metastatic breast cancer, particularly in the presence of estrogen receptor α gene (ESR1) mutations. To date, an international multi-center Phase 3 clinical trial of HLX78 in patients with ER+/HER2- metastatic breast cancer and have an ESR1 gene mutation has completed dosing of the first patient in China sites. This clinical trial is currently recruiting subjects in the U.S., Canada, the EU, China, in addition to other countries and regions. In two completed Phase 2 clinal studies (ELAINE-1 and ELAINE-2), lasofoxifene has demonstrated anti-tumor activity against tumors with ESR1 mutations as monotherapy and in combination with a CDK4/6 inhibitor. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, and, if approved, play a critical role in the precision medicine treatment of advanced ER+ breast cancer.
#Breast Cancer
Title: Pharmacokinetics (PK), safety, and tolerability of lasofoxifene in healthy Chinese female adults: results from an open-label, single-dose phase 1 study
Form: ePoster
Presentation Number: 192eP
Session: Poster Display session
Leading PI: Ling Guan, Dongguan People's Hospital
Time: Dec 5, 2025 5:15 PM-6:15 PM