Global First! ZhiXiang Jintai Submits NDA for Silevimig, the World’s First Bispecific Antibody for Rabies Post-Exposure Passive Immunization

On January 14, the National Medical Products Administration’s Center for Drug Evaluation (CDE) accepted the New Drug Application (NDA) for Selverimab Injection (GR1801 Injection), independently developed by GENRIX BIO, for the indication of passive immunization in adults following suspected rabies virus exposure, marking its formal submission for market approval. This isThe World's First Bispecific Antibody for Passive Immunization Against Rabies。

Slelumab Injection is a product developed byGENRIX BIO’s Independently Developed Recombinant Fully Human Bispecific Antibody Against Rabies Virus (RABV), classified as a Class 1 therapeutic biological product, with its target being the envelope glycoprotein (Glycoprotein, G protein) of RABV.

The rabies virus glycoprotein (G protein) is one of the most critical antigenic proteins of the rabies virus and plays a pivotal role during viral infection of the host. Silevemimab Injection prevents rabies by targeting and binding to epitopes I and/or III of the G protein, thereby blocking its interaction with cellular receptors and inhibiting viral neuroinvasion before active immunity induced by the rabies vaccine becomes fully protective.

Rabies is an acute, fatal neurological disease that affects nearly all mammalian species and is primarily caused by the rabies virus. Once clinical symptoms appear, the case fatality rate approaches 100%, making it one of the deadliest diseases in the world. Currently, approximately 59,000 people die from rabies globally each year. China ranks second worldwide in the number of rabies-related deaths, and rabies remains a significant public health concern both in China and around the world.^[1]。

The 2018 World Health Organization (WHO) position paper on rabies vaccines encourages the use of rabies monoclonal antibodies as an alternative to rabies immunoglobulin (RIG) where feasible; it further identifies the development of monoclonal antibody products containing two or more monoclonal antibodies with non-overlapping epitopes as a priority area, given that such combination formulations will enhance the efficacy and breadth of rabies virus neutralization.^[2]. The molecular design of Sileweimab injection meets the WHO recommendations for the development of anti-rabies virus antibodies, indicating broad prospects for future clinical application.

As of now, only two anti-rabies virus antibody drugs have been approved for marketing in China. GENRIX BIO’s Silevemimab is the first and currently the only bispecific antibody drug.

GENRIX BIO is dedicated to the research, development, and industrialization of antibody drugs in three major therapeutic areas: autoimmune diseases, infectious diseases, and oncology, with 15 products currently under development. Among these, secukinumab injection (Jinlixi®), the first domestically produced IL-17A-targeted drug for moderate-to-severe plaque psoriasis, was approved for market launch last August. A new drug application has been submitted for the indication of axial spondyloarthritis.

In addition to Slewevimab Injection, which is currently under application for market approval, another innovative product from GENRIX BIO in the field of anti-infectives—GR2001 Injection—has also entered Phase III clinical trials and was officially included in the Breakthrough Therapy Designation program by the Center for Drug Evaluation (CDE) last June for the prevention of tetanus. With the accelerated development of more pipeline products, more treatment options will be provided to doctors and patients in China and even globally in the future.

References:

[1] Liu Q, Gao J, Cao C, et al. Research progress on anti-rabies virus monoclonal antibodies[J]. Chinese Journal of Microbiology and Immunology, 2024, 44(4): 363-367. DOI: 10.3760/cma.j.cn112309-20230926-00089.

[2] World Health Organization. Rabies vaccines: WHO position paper, April 2018‑Recommendations[J]. Vaccine,2018, 36(37): 5500‑5503. DOI: 10.1016/j. vaccine. 2018.06.061.