China-based Chongqing Genrix Bio Pharmaceutical Co., Ltd. (SHA: 688443) has announced that a New Drug Application (NDA) filing for its silevimig (GR1801) has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The drug is intended for passive immunization in adults suspected of rabies virus exposure. This acceptance follows the recent achievement of the primary efficacy endpoint in the Phase III study for silevimig in this indication.
Silevimig: A Category 1 Biologic Product
Silevimig is a Category 1 biologic product and represents a significant innovation in the field of rabies treatment. It is an anti-rabies virus G protein bispecific antibody (BsAb), marking the world’s first BsAb for passive immunization against rabies. This groundbreaking drug is expected to offer a new and effective treatment option for patients at risk of rabies infection.
Market Competition and Potential Impact
Upon approval, silevimig is poised to compete with existing treatments in the Chinese market, such as North China Pharma’s ormutivimab and Synermore’s Keruibi (zamerovimab, mazorelvimab). This competition is expected to drive innovation and improve treatment outcomes for patients, further solidifying Chongqing Genrix’s position in the biopharmaceutical sector.-Fineline Info & Tech
Leave a Reply