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Henlius Received IND Approval for Its Novel Anti-LAG-3 mAb HLX26 from NMPA

Shanghai, China, April 15, 2021 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug (IND) application of its HLX26 (recombinant anti-LAG-3 human monoclonal antibody injection) has been approved by the National Medical Products Administration (NMPA) for treatment of solid tumors and 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. Currently, there is no LAG-3 targeted product on the market around the globe. A number of clinical studies have shown that LAG-3 inhibitors have obvious disease control effects in many solid tumors and hematological malignancy such as lung cancer, breast cancer, melanoma, head and neck cancer. A Phase III clinical study suggests that targeting the LAG-3 pathway in the combination with PD-1/L1 pathway effectively activates immune response, demonstrating the promising prospect of this product.

LAG-3 is an immune checkpoint receptor that is mainly expressed on human immune cells including activated T cells and part of NK cells, and negatively regulats the proliferation, activization and homeostasis of T cells[1-2]. HLX26 is a human mAb targeting LAG-3 extracellular domains, can block the LAG-3-mediated signaling pathway to restore the killing function of T-cell. Pre-clinical studies have proved that HLX26 has anti-tumor effect and favourable tolerability and safety. Particular in in vitro and animal model studies, HLX26 combined with Henlius’ proprietary anti-PD-1 mAb HLX10 creates synergistic effects in anti-tumor. These results lay the foundation for further clinical studies. HLX26 is expected to play an important role in the treatment of solid tumors and lymphomas, and expand the Company’s  therapeutic area.

At present, Henlius has built an all-round layout of the immune checkpoint products of PD-1/L1, CTLA-4 and LAG-3, etc., creating more opportunities for the exploration of combination immunotherapy. Looking forward, the Company will rely on extensive target development experience and integrated R&D platform actively developing more innovative products for patients, and build a high-quality, affordable and differentiated innovative product pipeline.

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.