After 17-year’s R&D, NCPC has successfully launched China’s first originated Recombinant Human Rabies Monoclonal Antibody into market

Date：2022-02-14  Author： View： 21

In the morning of February 12th, North China Pharmaceutical Co., Ltd., a subsidiary of Jizhong Energy Group, held a product release conference for Ormutivimab Injection (Trade name "Xunke") in Shijiazhuang. This is the first recombinant human monoclonal antibody against rabies virus in China, it is also the first biological drug authorized for marketing in Hebei Province.

At the scene of release conference for Omitevirumab Injection.

Xunke is a passive immune preparation, mainly used in combination with human rabies vaccine. When rabies virus exposure is vaccinated, the product can be infiltrated and injected around the wound to neutralize the virus and block the binding of the virus to cell surface receptors, so as to obtain immune protection in the window period before the vaccine produces antibodies.

According to Gao Jian, deputy general manager of North China Pharmaceutical Co., Ltd. and general manager of NCPC New Drug Company, the R&D process of Xunke is to introduce the anti-rabies virus antibody gene sequence derived from the human body into an animal cell, and cultivate the cell to mass proliferation (monoclonal cells), the engineered cells are used as seeds for large-scale cultivation, and then the antibodies produced by these cells are isolated and purified to produce medicines.

Wei Jingshuang, researcher of NCPC Research Institute and head of R&D of recombinant human anti-rabies virus monoclonal antibody injection project, said that when NCPC established recombinant human anti-rabies virus monoclonal antibody project in 2004, what the research team had was only gene sequence of the antibody. Facing cell culture, separation and purification, biological detection and other scientific research fields, they move forward step by step in breaking through various challenges. 

Wei Jingshuang said that over the past 17 years, the scientific research team has strived relentlessly to develop a large-scale serum-free culture process in bioreactor and a stable preparation process, which can prepare a high-purity anti-rabies virus monoclonal antibody product, this has ended the monopoly of foreign nations on human antibody development technology. . In 2006, the product’s efficacy was verified in animals; in 2007, the clinical trial was applied; in June 2009, the clinical trial permit was obtained; on January 25, 2022, the National Medical Product Administration authorized the product for marketing.  

Qi Shunxiang, director of Hebei Control Center Viral Disease Prevention and Control Institute, claimed that the launch of this product would contribute China’s  wisdom and strength in realizing the goal of WHO to eliminate human death linked with rabies by 2030.   

Before market authorization of Xunke , the passive immune preparations available for post-exposure defense against rabies virus in China were anti-rabies serum and immune globulin from rabies patients. The launch of Xunke fills the gap of recombinant anti-rabies virus monoclonal antibody, starts a new era of passive rabies immune preparations with a promising market outlook.