AGCO Biogenes antiviral class 1 new drug is planned to be included in breakthrough treatment products

According to the latest announcement by the Drug Review Center (CDE) of the State Drug Administration of China, ak0529 intestinal capsules, a class 1.1 new drug of Ayco bait, were included in the proposed breakthrough treatment on September 15.
this is a product under study that is included in the list in paragraph 5 of the CDE publicity.
the previous four anti-cancer drugs, AK0529 is a new anti-respiratory syncytial virus (RSV) drug, has entered phase 3 clinical.
Ak0529, in an International Phase 2 clinical proof-of-concept trial, confirmed for the first time that an antiviral drug is effective in treating RSV infection in hospitalized infants and young children and can bring clinical benefits to children, according to an earlier press release issued by Akob.
screenshot Source: CDE website AK0529 (Ziresovir) is the first new drug to be developed for Acosmos, a new type of RSV fusion protein inhibitor.
the product originated at Roche's China research and development center, and in June 2014 it obtained a global development rights license for AK0529 from Roche.
, according to public information, AK0529's antiviral mechanism is different from that of common nucleoside antiviral drugs that act on the replication process of glycolic acid in human cells.
, AK0529, as a novel compound, prevents the virus from entering human cells by binding to the fusion protein of the respiratory syncytial virus, thus preventing infection-induced diseases.
this fusion protein inhibitor can also enhance antiviral effects by blocking cell-cell fusion, an important feature of the formation of "cytosomes", respiratory syncytial virus-infected cells.
November 2019, Acostic announced that AK0529 had completed an international Phase 2 clinical proof-of-concept trial for the treatment of inpatient infants and young children, with ground-breaking results.
in this clinical trial, candidate drugs showed dose-related clinical effectiveness, significantly reducing the clinical signs and symptom scores of patients, while reducing the 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 AK0529 drugs.
addition, AK0529 maintains its excellent safety characteristics in hospitalized infants and young children.
china drug clinical trial registration and information publicity platform, the current Acostic has launched AK0529 for infant RSV infection Phase 3 clinical research, as well as the product for adult RSV infection Phase 2 clinical research.
addition, the product is also in Australia, the United Kingdom and other places to conduct clinical research.
respiratory syncytial virus is one of the most contagious human susceptible viruses, infecting 3% to 10% of the world's population each year.
all ages may be infected with RSV, but infection is most dangerous in infants and the elderly.
the virus can cause pneumonia, bronchitis and other lower respiratory diseases, and many patients infected with RSV may not be properly diagnosed because symptoms are difficult to distinguish from influenza or other respiratory infections.
, RSV remains a huge global health problem and financial burden due to the absence of preventive vaccines or effective antiviral therapies.
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