Shanghai, China, March 25, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the National Medical Products Administration (NMPA) has approved the investigational new drug (IND) application for a phase 2 clinical trial for the potential first-in-class human sialidase enzyme therapeutic, HLX79 (E-602), in combination with Henlius’ self-developed HANLIKANG (rituximab) in patients with active glomerulonephritis. HANLIKANG, approved in 2022 for rheumatoid arthritis, remains the only rituximab approved for an autoimmune indication in China.

End stage renal disease (ESRD), the last stage of chronic kidney disease (CKD), is characterised by near-total loss of kidney function, resulting in the need for renal replacement therapy. Patients face high disease severity, complications, and substantial economic burden due to the costs of treatment^[1]. China accounts for nearly 30% of global ESRD cases, with approximately 3.5 million patients^[2]. Glomerulonephritis can be classified into primary forms (e.g., membranous nephropathy [MN], focal segmental glomerulosclerosis [FSGS]) and secondary forms (e.g., lupus nephritis [LN], anti-neutrophilic cytoplasmic antibodies [ANCA]-associated vasculitis [AAV]), representing the leading cause of ESRD in China^[1].

Depleting B cells with targeted antibodies such as rituximab (anti-CD20 mAb), has been approved in multiple markets and is recognised by Chinese nephrology expert consensus for the treatment of glomerulonephritis. However, many patients have inadequate response to these drugs. Glyco-immunology provides a new approach to treating autoimmunity by enhancing depletion of activated memory B cells, the pathogenic subset of B cells associated with disease progression and often resistant to antibody-mediated depletion. HLX79 enzymatically degrades sialoglycans—immunosuppressive cell surface sugars that protect pathogenic memory B cells from depletion by B cell-targeted antibodies.

HLX79 is a first-in-class human sialidase enzyme therapeutic developed from Palleon’s EAGLE glycan editing platform. Preclinical studies of HLX79 in combination with rituximab demonstrate improved outcomes versus rituximab alone without the risk of cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS) associated with CAR T and T cell engagers. HLX79 has demonstrated a favourable safety profile with no dose-limiting toxicities in human clinical trials. It is expected that the combination of HANLIKANG and HLX79 will benefit patients with active glomerulonephritis.

Looking forward, Henlius will continue to promote the layout of our innovative portfolio by focusing on antibody technology, bringing more high-quality and affordable therapeutics to patients worldwide.

【References】

[1] Chinese Society of Nephrology. Expert consensus on the use of rituximab in glomerulonephritis[J]. Chinese Journal of Nephrology, 2022, 38(2): 151-160. DOI: 10.3760/cma.j.cn441217-20210615-00023.

[2] IQVIA’s White Paper on End-Stage Renal Disease in China, 2023