淋巴细胞活化基因3（lymphocyte-activation gene 3，lag-3）是一种免疫检查点受体蛋白，被视为继pd-1/l1、ctla-4后新一代的免疫治疗靶点，全球目前暂无该靶点产品上市。多项临床研究数据显示，lag-3抑制剂在肺癌、乳腺癌、黑色素瘤和头颈癌等多种实体瘤和血液肿瘤中均有明显的疾病控制效果，已有iii期临床研究显示其与pd-1抑制剂联用可协同增强免疫应答，具有广阔的肿瘤治疗应用前景。
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. 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.
henlius (2696.hk) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. up to date, 3 products have been launched in china, 1 in the european union (eu), the new drug applications (nda) of 2 products accepted for review in china. since its inception in 2010, henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including r&d, manufacturing and commercialisation. it has established global r&d centers and a shanghai-based manufacturing facility certificated by china and the eu good manufacturing practice (gmp).
henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mabs) and has continued to explore immuno-oncology combination therapies with proprietary hlx10 (anti-pd-1 mab) as backbone. apart from the launched products 汉利康® (rituximab), the first china-developed biosimilar, 汉曲优® (trastuzumab, zercepac® in the eu), the first china-developed mab biosimilar approved both in china and in the eu and 汉达远® (adalimumab), the company's first product indicated for autoimmune diseases, the nda of hlx04 (bevacizumab) and hlx01 (rituximab) for the treatment of rheumatoid arthritis are under review. what's more, henlius has conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide, expanding its presence in major market as well as emerging market.
 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.
 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.