Changchun Bcht Biotechnology (688276.SH): Clinical Trial Application for Recombinant Human Anti-Respiratory Syncytial Virus Monoclonal Antibody Injection Combination Formulation Accepted
Bcht Biotechnology (688276.SH) announced that the company recently received the "Notice of Acceptance" for the clinical trial application of the recombinant human anti-respiratory syncytial virus monoclonal antibody injection combination formulation (referred to as "RSV antibody") issued by the National Medical Products Administration.
Changchun Bcht Biotechnology (688276.SH) announced that the company recently received the "Notice of Acceptance" from the National Medical Products Administration for the clinical trial application of its recombinant human anti-respiratory syncytial virus monoclonal antibody injection combination formulation (referred to as "RSV antibody").
The RSV antibody accepted this time is intended for the prevention of 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 an entire RSV epidemic season with a single dose, improving medication compliance and convenience of prevention in the population.
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