Shanghai, China, January 9th, 2025 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the latest clinical data of two Henlius products, the anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab) and an innovative anti-HER2 mAb HLX22, will be presented in posters at the 2025 ASCO Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, United States from January 23-25.

HANSIZHUANG (serplulimab), Henlius’ first self-developed innovative Anti-PD-1 mAb, is the world’s first anti-PD-1 mAb for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Up to date, it has been approved in China and several Southeast Asian countries. 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. In China, it has been approved by the NMPA for the treatment including squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC), etc. Furthermore，the marketing application of the first-line treatment for ES-SCLC is under review by the European Medicines Agency (EMA). Besides, the company has initiated more than 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications with more than 4,800 subjects enrolled worldwide.

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^[1]. Results from HLX22-GC-201, a phase 2 study of HLX22 in combination with trastuzumab injection (HLX02) and XELOX, as first-line therapy for HER2-positive locally advanced or metastatic gastric cancer patients were subsequently presented at the 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), 2024 ESMO Gastrointestinal Cancers Congress (ESMO GI) and on Med, a flagship medical journal by Cell Press, respectively. Updated results and study data showed that the addition of HLX22 to HLX02 (trastuzumab) plus chemotherapy as first-line therapy improved efficacy in HER2-positive G/GEJ cancer patients with manageable safety^[2-4].
 
Details of the results to be presented at 2025 ASCO GI are as follows:

HLX10
Title: Updated efficacy and subgroup analysis of first-line serplulimab plus bevacizumab 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: 170
Onsite Poster display date: 2025/1/25
Leading PI: Rui-Hua Xu, Sun Yat-sen University Cancer Center

Title: Safety and efficacy of perioperative chemotherapy combined with PD-1 inhibitor versus chemotherapy with D2 gastrectomy plus PAND in gastric cancer with PALD metastasis: A single-center retrospective cohort study
Session: Poster Session A: Cancers of the Esophagus and Stomach and Other Gastrointestinal Cancers
Presentation Number: 368
Onsite Poster display date: 2025/1/23
Leading PI: Yian Du, Zhejiang Cancer Hospital

HLX22
Title: HLX22 plus trastuzumab and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction cancer (G/GEJC): Updated results with additional patients
Session: Poster Session A: Cancers of the Esophagus and Stomach and Other Gastrointestinal Cancers
Presentation Number: 440
Onsite Poster display date: 2025/1/23
Leading PI: Jin Li, Shanghai GoBroad Cancer Hospital

【Reference】
[1] Zhu X, Ding Y, Wang Q, Yang G, Zhou L, Wang Q. HLX22, an anti-HER-2 monoclonal antibody, in patients with advanced solid tumors overexpressing human epidermal growth factor receptor 2: an open-label, dose-escalation, phase 1 trial. Invest New Drugs. 2023;41(3):473-482. doi:10.1007/s10637-023-01338-7
[2] Jin Li et al., 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.. JCO 42, 354-354(2024).DOI:10.1200/JCO.2024.42.3_suppl.354
[3] J. Li et al., 422P HLX22 plus HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric/gastroesophageal junction cancer: Updated results from a randomized, double-blind phase II study, Annals of Oncology,Annals of Oncology (2024) 35 (suppl_1): S162-S204. 10.1016/annonc/annonc1482
[4] Li N, Qiu M, Zhang Y, et al. A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer. Med. 2024;5(10):1255-1265.e2. doi:10.1016/j.medj.2024.06.004