North China Pharmaceutical's Class 1 new drug Omotivizumab for rabies is about to be approved

On August 5, the official website of NMPA showed that North China Pharmaceutical's Class 1 new drug omiltivizumab has entered the approval stage and is expected to be approved in the near future (acceptance number: CXSS2000040) for passive immunization of patients exposed to rabies virus

Source: NMPA official website

Rabies is an acute infectious disease.

Recombinant human-derived anti-rabies monoclonal antibody injection (rhRIG) is an independent innovation project of North China Pharmaceutical, and is listed as a major scientific and technological special product of the country's "Major New Drug Creation"

In April 2020, the clinical results of rhRIG Project III showed that the post-exposure prevention of rhRIG combined with human rabies vaccine for people exposed to suspected rabies virus at level III reached the primary efficacy and secondary efficacy endpoints, and the safety was good, reaching the goals set by the plan

According to the Insight database, currently, there is no recombinant anti-rabies monoclonal antibody on the market in China.

Source: Insight database (http://db.

As the first recombinant human-derived rabies monoclonal antibody, Omutavir monoclonal antibody is highly anticipated