Changchun Bcht Biotechnology Wins Acceptance for RSV Antibody Trial Application

Stock News

Sep 22

Changchun Bcht Biotechnology Co. (SH: 688276) has announced that it recently received the Acceptance Notice from the National Medical Products Administration regarding the clinical trial application for its recombinant human anti-respiratory syncytial virus monoclonal antibody injection combination preparation, referred to as the RSV antibody.

The RSV antibody accepted for review is intended to prevent lower respiratory tract infections caused by RSV in newborns and infants. Preclinical in vivo and in vitro pharmacodynamic studies have demonstrated that the product exhibits strong efficacy; preclinical toxicology studies indicate that the product is generally well tolerated, safe, and controllable.

Additionally, the product enables a single-dose administration to cover a complete RSV epidemic season, thereby enhancing patient medication adherence and the convenience of prevention.

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