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[Tylenumab: Riteviribumab injection has been approved for marketing by the State Food and Drug Administration] On September 3, Tylenumab (688806.SH) announced that the company received a notice from the State Food and Drug Administration to approve the independently developed Class 1 innovative drug Riteviribumab injection for children through the priority review and approval process. This product is suitable for preventing lower respiratory tract infections caused by RSV in newborns and infants who are about to enter or are born in the first respiratory syncytial virus epidemic season. Key Phase III clinical trials showed that within 150 days after administration, the protective efficacy against RSV lower respiratory tract infections requiring medical treatment and hospitalization resulted in 71.3% and 71.7%, and the protective efficacy against severe RSV LRT increased to 93.9% and 90.1%. This product is the world's first RSV monoclonal antibody with clinical protection data of up to nine months after one injection. This approval marks the successful launch of the company’s second independently developed fully human monoclonal antibody innovative drug.

#clinical trial #clone #Virus #A-share announcement express09-03 16:54