Jioncare‘s marketing application for anti-flu drug TG-1000 capsules accepted

  On August 12, the CDE‘s official website showed that the marketing application for Healthwon‘s anti-influenza drug TG-1000 capsules had been accepted. The drug is an innovative new anti-influenza Class 1 drug, a novel cap-dependent nucleic acid endonuclease inhibitor for adults and adolescents 12 years of age and older with uncomplicated acute infections of influenza A and B alone.

   In April this year, Healthwon announced that the multi-center Phase III clinical trial of TG-1000 capsules for the treatment of uncomplicated acute infections of simple influenza A and B in patients aged 12 years and above had reached the primary study endpoint, and indicated that it would communicate with the Center for Drug Evaluation (CDE) of the State Drug Administration regarding the marketing application of TG-1000 capsules for the treatment of influenza in the near future to push forward the TG-1000 capsule The study was a multi-center, randomized, and controlled trial. The study is a multi-center, randomized, double-blind clinical trial, the primary study endpoint is the time to remission of all influenza symptoms within 15 days of the treatment period. Preliminary statistical analyses showed that the median time to remission of all influenza symptoms in the TG-1000 group versus the placebo group was 60.9 hours and 87.9 hours, respectively, which met the primary efficacy index and was statistically different (p<0.0001). In terms of safety, the incidence of adverse events (AEs) in the TG-1000 group was similar to that of the placebo group, with no deaths or drug-related serious adverse reactions.

   Influenza, a contagious respiratory disease caused by influenza viruses, is currently one of the world‘s most serious public health challenges. Seasonal influenza occurs frequently each year. The three main classes of antiviral drugs currently available for the treatment and control of influenza are neuraminidase inhibitors (e.g., oseltamivir, palamivir, etc.), hemagglutinin inhibitors, and RNA polymerase inhibitors (e.g., marbofloxacavir).

  Among them, Marbofloxacavir is the world‘s first approved new mechanism anti-influenza drug, which inhibits viral replication by inhibiting the cap-dependent nucleic acid endonuclease of influenza virus, and has been approved for the treatment and prevention of influenza. Its sales have increased significantly since its launch, and it has rapidly captured most of the market for anti-influenza drugs. RNA polymerase inhibitors represented by it have become a new direction in the research and development of anti-influenza virus drugs.