The 2026 American Society of Clinical Oncology Gastrointestinal Cancers Sympotsium (ASCO GI 2026) will be held in San Francisco, California from Januarary 8 to 10, 2026. At this year's conference, Henlius (2696.HK) will, for the first time, showcase the Phase 2 proof-of-concept data for its broad-spectrum anti-tumor PD-L1 antibody-drug conjugate (ADC) HLX43 in the treatment of advanced esophageal squamous cell carcinoma (ESCC). Additionally, results from two neoadjuvant studies of serplulimab, the anti-PD-1 monoclonal antibody (mAb) in colorectal cancer and the phase 3 study design of a head-to-head, multi-regional clinical trial for the novel epitope anti-HER2 mAb HLX22 will be released. These presentations together showcase the company's innovative layout and advancements in the field of gastrointestinal cancers.
HLX43: A Potential Best-in-Class PD-L1 ADC with Broad-Spectrum Anti-Tumor Activity and Immuno-Oncology Efficacy
HLX43 is a potential best-in-class 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 were 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, preliminary clinical data for HLX43 have been observed in thymic carcinoma (TC) and cervical cancer (CC), with more data expected from other tumor types, reforcing its broad therapeutic potential across solid tumors. To date, Henlius has initiated about 10 clinical studies of HLX43, covering lung cancer, CC, ESCC, head and neck squamous cell carcinoma (HNSCC), nasopharyngeal carcinoma (NPC), colorectal cancer, gastric/gastroesophageal junction cancer (G/GEJ), pancreatic ductal adenocarcinoma (PDAC), and hepatocellular carcinoma (HCC), with over 500 patients enrolled globally. At the upcoming ASCO GI conference, Henlius will, for the first time, release the Phase 2 proof-of-concept data for HLX43 in patients with recurrent/metastatic ESCC, further validating the therapeutic potential of the product in gastrointestinal cancers and expanding its broad-spectrum anti-tumor profile.
Title：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
Format：Poster
Session：Poster Session A: Cancers of the Esophagus and Stomach and Other Gastrointestinal Cancers
Presentation Number：C21
Leading PI：Jingming Yu, Shandong Cancer Hospital
Time：Jan 8, 2026, 11:30 AM-1:00 PM; 6:00 PM-7:00 PM (PST)
Serplulimab: World's First and Only Anti-PD-1 mAb with Positive Results from a Phase 3 Registrational Trial in the Perioperative Rreatment of Gastric Cancer
Serplulimab is the world’s first and only anti‑PD‑1 mAb to have succeeded in a phase 3 registration study for perioperative gastric cancer, to receive Breakthrough Therapy Designation from the CDE as well as being granted Priority Review for the treatment of this indication. Meawhile, it is the first anti-PD-1 mAb approved for the first-line treatment of small cell lung cancer (SCLC). Up to date, serplulimab 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 (nsqNSCLC). It has been approved in over 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, Korea MFDS and Mexico COFEPRIS. At the conference, Henlius will present findings from two Phase 2 neoadjuvant studies of serplulimab in advanced colorectal cancer. The data highlight its potential to improve opportunities for curative surgery in high-risk locally advanced colon cancer and "optimize" treatment pathways for patients with advanced rectal cancer—challenging the current standard by exploring immunotherapy combined with chemotherapy as an alternative to radiotherapy.
Title：Neoadjuvant short-course radiotherapy combined with CAPOX and PD-1 inhibitor for MSS/pMMR high-risk locally advanced colon cancer: A randomized, prospective, multicentre, phase II trial (TORCH-C)
Format：Poster
Session：Poster Session A: Cancers of the Esophagus and Stomach and Other Gastrointestinal Cancers
Presentation Number：F11
Leading PI：Sanjun Cai, Zhen Zhang, Fudan University Shanghai Cancer Center
Time：Jan 10, 2026, 7:00 AM-7:55 AM (PST)
Title：Neoadjuvant chemotherapy and serplulimab in MSS/pMMR locally advanced rectal cancer (FIRM): a phase II trial
Format：Poster
Session：Poster Session C: Cancers of the Colon, Rectum, and Anus
Presentation Number：E7
Leading PI：Peng Du, Xinhua Hospital Affliated to Shanghai Jiao Tong University School of Medicine
Time：Jan 10, 2026, 7:00 AM-7:55 AM (PST)
HLX22：Shows Potential to Redefine the Global First-Line Treatment Landscape for HER2-Positive Gastric Cancer
HLX22, an innovative anti-HER2 mAb, can bind to HER2 extracellular subdomain IV at a binding site different from that of trastuzumab via differentiated molecular design and mechanism of action, which allows simultaneous binding of HLX22 and trastuzumab to HER2 dimers (HER2 homodimer and HER2/EGFR heterodimer) on tumour cell surface, resulting in a 40%–80% increase in HER2 internalisation.
HLX22-GC-301 is a randomized, double-blind, international Phase 3 trial directly comparing HLX22 in combination with trastuzumab and chemotherapy versus the current first-line standard of care (trastuzumab + chemotherapy ± pembrolizumab) for HER2-positive advanced gastric cancer.
The trail is designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as a first-line treatment for patients with HER2-positive locally advanced or metastatic gastric cancer (GC) or gastroesophageal junction cancer (GEJC), in direct comparison with the current standard regimen of trastuzumab plus chemotherapy, with or without pembrolizumab. It has been initiated across multiple countries and regions, including China, the United States, Japan, Australia and Argentina. Notably, HLX22-GC-301 does not limit enrolment by PD-L1 status, aiming to overcome clinical limitations of current first-line treatment paradigms for HER2-positive gastric cancer. In recognition of its potential, HLX22 has been granted Orphan Drug Designation (ODD) for gastric cancer by both the U.S. FDA and the European Commission in 2025, highlighting its global development prospects and clinical value.
Title：A randomized, double-blind, international phase 3 trial comparing HLX22 in combination with trastuzumab and chemotherapy versus trastuzumab andchemotherapy with or without pembrolizumab for first-line treatment for HER2-positive locally advanced or metastatic G/GEJC
Format：Poster
Session：Trials in Progress Poster Session A: Cancers of the Esophagus and Stomach and Other Gastrointestinal Cancers
Presentation Number：J24
Co-leading PI：Lin Shen, Peking University Cancer Hospital; Jaffer A. Ajani, MD Anderson Cancer Center
Time：Jan 8, 2026, 11:30 AM-1:00 PM (PST)