Changchun High-Tech Industry (000661.SZ): Clinical trial application for the recombinant human anti-respiratory syncytial virus monoclonal antibody injection combination product has been accepted.

Changchun High-Tech Industry (000661.SZ) announced that its subsidiary Changchun Bcht Biotechnology Co., Ltd. (referred to as "Changchun Bcht Biotechnology") recently received the "Notice of Acceptance" issued by the National Medical Products Administration for the clinical trial application of the recombinant human anti-respiratory syncytial virus monoclonal antibody injection combination product (referred to as "RSV antibody"). It is reported that the RSV antibody accepted for Changchun Bcht Biotechnology this time is used to prevent lower respiratory tract infections caused by RSV in newborns and infants. Preclinical in vivo and in vitro pharmacodynamic studies have shown that the product has good efficacy; preclinical toxicology studies have shown that the product has good overall tolerability and is safe and controllable; the product can achieve coverage of a complete RSV epidemic season with a single dose, improving medication compliance and convenience of prevention for the population.