Shanghai, China, October 12th, 2021 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first subject has been dosed with HLX26 (recombinant anti-LAG-3 human monoclonal antibody injection) for the Phase 1 clinical trial in patients with advanced/metastatic solid tumours or lymphomas. Lymphocyte-activation gene 3 (LAG-3) is an immune checkpoint receptor and is regarded as a new generation of immunotherapy target after PD-1/L1 and CTLA-4. There is no product approved for this target around the globe. Clinical studies show that LAG-3 inhibitors are effective against lung cancer, breast cancer, melanoma, head and neck cancer, and hematological malignancy. Clinical studies reveal that LAG-3 inhibitors are effective against lung cancer, breast cancer, melanoma, head and neck cancer, and hematological malignancy. In a Phase 3 clinical study, the LAG-3 inhibitors in conjunction with the PD-1 inhibitor magnify the synergistic immune response effects. Recently, the study-related Biologics License Application has been accepted by the FDA, demonstrating the promising prospect of this product.


LAG-3 is mainly expressed on human immune cells, including activated T cells and part of NK cells, and negatively regulates T cells' proliferation, activation, and homeostasis^[1-2]. HLX26 is a human mAb targeting LAG-3 extracellular domains, can block the LAG-3-mediated signalling pathway to restore the killing function of T-cell. Pre-clinical studies have proved that HLX26 has the anti-tumour effect and favourable tolerability and safety. HLX26 in combination with Henlius' proprietary anti-PD-1 mAb serplulimab creates synergistic effects in anti-tumour. These results lay the foundation for further clinical studies. HLX26 is expected to play an essential role in treating solid tumours and lymphomas and expand the company's therapeutic area.

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. The company has also built an innovative product pipeline with many emerging targets, including c-MET, LAG-3, TROP2, BRAF, etc. and has been developing a forward-looking presence in bispecific antibodies and the antibody-drug conjugates (ADC), committing to bringing affordable and high-quality innovative biologics to patients around the world.

Reference Notes:

[1] Ruffo E, Wu R C, Bruno T C, et al. Lymphocyte-activation gene 3 (LAG3): the next immune checkpoint receptor[C]//Seminars in immunology. Academic Press, 2019, 42: 101305.
[2] Solinas C, Migliori E, De Silva P, et al. LAG3: the biological processes that motivate targeting this immune checkpoint molecule in human cancer[J]. Cancers, 2019, 11(8): 1213.