HLX22 is an innovative anti-HER2 mAb that was introduced from AbClon, Inc. and further researched and developed by Henlius. HLX22 can bind to HER2 subdomain IV at a different binding site from trastuzumab, which allows the simultaneous binding of HLX22 and trastuzumab to HER2. The pre-clinical studies showed that the combination therapy of HLX22 and trastuzumab would inhibit the cell proliferation induced by epidermal growth factor (EGF) and Histidine-Rich Glycoprotein 1 (HRG1) and enhance the antitumor activity in vitro and in vivo. The phase 1 clinical trial of HLX22 demonstrates that HLX22 is well tolerated and has good safety profiles. As of now, no similar dual HER2 blockade therapy for the treatment of HER2-positive gastric cancer has received approval for commercialization globally.

HANSIZHUANG (serplulimab) is the first innovative mAb developed by Henlius. Since launched in March 2022, HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small-cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC). In December 2023, HANSIZHUANG was approved in Indonesia for the treatment of ES-SCLC. The marketing applications of the first-line treatment for non-squamous non-small cell lung cancer (nsNSCLC) and ES-SCLC are under review by the NMPA and the European Medicines Agency (EMA), respectively. Underpinned by the patient-centric strategy, Henlius has carried out a differentiated and multi-dimensional layout in the field of gastrointestinal cancer and lung cancer, covering a wide variety of indications, such as lung cancer, ESCC, head and neck squamous cell carcinoma and gastric cancer, etc. To date, more than 3,600 subjects have been enrolled worldwide for HANSIZHUANG clinical trials.

Details of the results to be presented at 2024 ASCO GI are as follows:

1. HLX22-GC-201

Title: HLX22 plus HLX02 and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction cancer: A randomized, double-blind, multicenter phase 2 study

Session: Poster Session A: Cancers of the Esophagus and Stomach and Other GI Cancers

Presentation Number: 354

Onsite Poster display date: 2024/1/18

Leading PI: Jin Li, Shanghai East Hospital, School of Medicine, Tongji University

2. HLX10-015-CRC301

Title: First-line serplulimab plus HLX04 and XELOX versus placebo plus bevacizumab and XELOX in metastatic colorectal cancer: A phase 2/3 study

Session: Poster Session C: Cancers of the Colon, Rectum, and Anus

Presentation Number: 124

Onsite Poster display date: 2024/1/20

Leading PI: Rui-Hua Xu, Sun Yat-sen University Cancer Center