Huabei Pharmaceutical's new rabies drug, omiltivizumab, has not been approved for large specifications

Article source: Medical Rubik's Cube Info

On August 12, North China Pharmaceutical submitted a new class 1 recombinant human anti-rabies monoclonal antibody (ormutivimab) for the passive immunization of rabies virus-exposed patients.

Omotivirumab (rhRIG, NM57) 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”.

On June 28, 2007, North China Pharmaceutical submitted the first clinical trial application for this product (200 IU/bottle, 500 IU/bottle), and obtained the clinical trial approval on June 25, 2009

Huabei Pharmaceutical obtained the Phase III clinical trial approval issued by CFDA in July 2018

The conclusion of the trial reviewed by experts is that the post-exposure prevention of rhRIG combined with human rabies vaccine on people who are exposed to suspected rabies virus at level III reaches the primary efficacy and secondary efficacy endpoints, and the safety is good, reaching the target set by the protocol.

The passive immunization agents currently used for rabies virus post-exposure prevention in China are mainly anti-rabies serum (ERIG) and HRIG