North China Pharmaceutical Group Corporation (SHA: 600812) has announced that it has received approval from the National Medical Products Administration (NMPA) for a new indication for its Category 1 therapeutic biologic, ormutivimab. The drug, a recombinant humanized rabies virus monoclonal antibody (mAb), is now approved for use in children aged two and above, expanding its application beyond the adult population for which it was previously approved in January 2022.
Developed in-house, ormutivimab is used in conjunction with the human rabies vaccine, serving as an antibody during the active immunization process. It directly neutralizes the rabies virus within the body, providing a passive immune response. The treatment is indicated for passive immunization in patients who have been bitten or scratched by animals known to carry or be susceptible to the rabies virus. With no similar product currently approved in China, ormutivimab stands out in a market where antirabies serum and rabies human immunoglobulin are the existing alternatives.- Flcube.com