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On September 15th, the CDE website published the 5th list of proposed breakthrough treatment varieties, AK0529 intestinal capsules, a new drug for aico 100 anti-respiratory syncytial virus.
the drug was introduced from Roche in June 2014 and Acostic owns a global interest in the drug.
respiratory syncytial virus (RSV) is a highly contagious human virus that infects 3-10% of the world's population each year and is the most common cause of acute lower respiratory diseases in infants and young children.
one of the leading causes of death from lower respiratory tract infections, fine bronchitis, and hospitalization of infants under 5 years of age.
there are about 34 million cases of lower respiratory tract infections among children worldwide each year, of which up to 200,000 are among children under 5 years of age.
, respiratory syncytial viruses can cause severe lung infections and deaths in the elderly.
AK0529 (Ziresovir) was invented after further structural optimization after screening cell-based high-volume compounds for active compounds.
followed up with a comprehensive preclinical and toxicology assessment of the drug, including an early childhood animal toxicology study.
Ziresovir is a novel compound that binds to the fusion protein of respiratory syncytial viruses to prevent the virus from entering human cells, thereby preventing diseases caused by infection.
this fusion protein inhibitor can also achieve antiviral effects by preventing cell-to-cell fusion (i.e., the formation of "cytosomes", characteristics of respiratory syncytial virus-infected cells).
, Ziresovir's mechanism of effect is different from that of common nucleoside antiviral drugs and does not interfere with the synthesis of nucleotides in human cells, resulting in mitochondrial toxicity.
2019 successfully completed a Global Phase II Clinical Study (VICTOR), which for the first time in history confirmed that an antiviral drug is effective in treating RSV infection in hospitalized infants and young children and can bring clinical benefits to children.
clinical trial, Ziresovir (AK0529) showed dose-related clinical effectiveness, significantly reducing the clinical signs and symptom scores of patients while reducing viral load in their bodies.
the trial also confirmed a significant positive correlation between the patient's clinical signs and symptom scores and the degree of change in viral load and the concentration of Ziresovir drugs.
addition, Ziresovir maintains its excellent safety characteristics in hospitalized infants and young children.
Isco has launched a Phase III clinical study of Ziresovir in China and will immediately conduct a global Phase III clinical study outside Chinese mainland;
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