Changchun High-Tech Industry (Group) Co.,Ltd. (000661.SZ) announced that its subsidiary, Changchun Baike Biological Technology Co., Ltd. ("Baike Bio"), recently received the "Acceptance Notice" from the National Medical Products Administration for the clinical trial application of the recombinant human anti-respiratory syncytial virus monoclonal antibody injection combination preparation (referred to as "RSV antibody").
The RSV antibody accepted this time is intended to prevent lower respiratory tract infections caused by RSV in newborns and infants. Preclinical in vivo and in vitro pharmacodynamic studies indicate that the product demonstrates good efficacy; preclinical toxicology studies show that the product is generally well-tolerated and has a manageable safety profile. Additionally, a single administration can cover an entire RSV epidemic season, enhancing patient compliance and the convenience of prevention.