Shanghai, China, May 5th, 2023 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug application (IND) for a phase 2 clinical trial of HANSIZHUANG (serplulimab), an innovative anti-PD-1 monoclonal antibody (mAb) independently developed by the company, in combination with HLX26, an innovative anti-LAG-3 mAb, and chemotherapy for the first-line treatment of advanced non-small cell lung cancer (NSCLC) has been approved by the National Medical Products Administration (NMPA).
HLX26 is a human mAb targeting lymphocyte-activation gene 3 (LAG-3) extracellular domains. HLX26 can block the LAG-3-mediated signalling pathway to restore the killing function of T-cell. Pre-clinical studies proved that HLX26 has the anti-tumour effect and favourable tolerability and safety. Furthermore, in vitro and animal studies showed that HLX26 in combination with serplulimab have a significant synergistic effect in anti-tumour. These results lay the foundation for further clinical studies on combination usage. In August 2022, the first subject has been dosed for a phase 1 clinical trial of HANSIZHUANG in combination with HLX26 for the treatment of advanced/metastatic solid tumours or lymphomas.
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) and extensive-stage small cell lung cancer (ES-SCLC) and benefited more than 20,000 Chinese patients. What's more, several clinical data of HANSIZHUANG have been recognized by authoritative international journals. The results of the phase 3 clinical study on extensive-stage small cell lung cancer, ASTRUM-005, were published in the Journal of the American Medical Association (JAMA, IF 157.3), one of the top four medical journals in the world, which made ASTRUM-005 the first study published on JAMA in SCLC immunotherapy. Henlius continues to explore the combination therapies between HANSIZHUANG and self-developed products such as HANBEITAI, HLX07 (anti-EGFR mAb), HLX26 (anti-LAG-3 mAb), HLX208 (BRAF V600E small molecule inhibitor) and HLX60 (anti-GARP mAb) to provide better therapies for the patients, 14 clinical trials on immuno-oncology combination therapies are in progress in a wide variety of indications and has enrolled more than 3,500 patients worldwide.
Underpinned by the patient-centric strategy, Henlius has achieved an overall layout of the immune checkpoint products of PD-1/L1, CTLA-4, LAG-3, etc., proactively exploring immuno-oncology combination therapy, and the company will commit to bringing affordable and high-quality innovative biologics to patients around the world.
About HANSIZHUANG
HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first anti-PD-1 mAb for the first-line treatment of SCLC. Up to date, 3 indications are approved for marketing in China, 2 marketing applications are under review in China and the EU, and more than 10 clinical trials are ongoing across the world.
HANSIZHUANG was launched in March 2022 and has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC). The marketing applications of the first-line treatment for esophageal squamous cell carcinoma (ESCC) and ES-SCLC are under review by the NMPA and the EMA, respectively. Focus on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate 14 clinical trials on immuno-oncology combination therapies in a wide variety of indications. As of now, the company has enrolled more than 3,500 subjects in China, the U.S., Turkey, Poland, Georgia and other countries and regions, and the proportion of White is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The results of 3 pivotal trials of HANSIZHUANG were published in theJournal of the American Medical Association (JAMA, IF: 157.3), Nature Medicine (IF: 87.241), and the British Journal of Cancer (IF: 9.075), respectively. On the other hand, HANSIZHUANG was recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines for Esophageal Cancer, the CSCO Guidelines for Colorectal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumors. Furthermore, Serplulimab was granted orphan drug designations by the FDA and the EC for the treatment of SCLC, and the first patient has been dosed in a bridging head-to-head trial in the United States to comparing HANSIZHUANG to standard of care Atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC.