November 23, 2023, Beijing time
The results of a phase Ⅲ clinical study of the domestic COVID-19 oral drug Mindvy? (Deuremidevir hydrobromide tablets, product code: VV116/JT001) co-developed by Vigonvita, were published on the authoritative periodical in the field of infectious diseases , The Lancet Infectious Diseases (IF: 56.3); previously the results of the “head-to-head” phase Ⅲ clinical study (NCT05341609) were published in the top international medical journal, New England Journal of Medicine (IF:158.5); and now the results of the Phase III clinical study (NCT05582629) are published in an international authoritative medical journal again.This marks the international academic community’s recognition for the efficacy and safety of the domestic original innovative COVID-19 oral drug Mindvy?.

Source: Official website of The Lancet Infectious Diseases

This clinical study was led by Academician Li Lanjuan, Director of the State Key Laboratory of Diagnosis and Treatment of Infectious Diseases at Zhejiang University, and was conducted in 31 hospitals across China. Statistically and clinically significant results were obtained in the interim analysis of the study. Compared with placebo, treatment of adult patients (≥18 years old) with mild to moderate COVID-19 infection with Mindvy? significantly shortened the disappearance time of 11 clinical symptoms, including cough, rhinorrhea, fever, diarrhea, etc., with a median time of 2 days shorter than that of the placebo group (HR=1.21, P=0.0023); and the results of the final analysis were consistent with the interim analysis, with the median time to symptom disappearance being 2 days shorter than that of the placebo group (HR=1.17, P=0.0009), indicating that the clinical data of Mindvy? is the best among the reported data of domestic and international COVID-19 oral medicines, which is a further demonstration of its efficacy benefit; the data of the subgroup analysis of the elderly patients aged 60 years or above were consistent with the overall population.Encouragingly,the study demonstrated that significant benefits can be realized after treatment with Mindvy?, regardless whether the patients have high risk factors for progression to severe disease or whether they have been vaccinated with the COVID-19 vaccine.

Dr. Guanghui Tian, Chairman and General Manager of Vigonvita, said:
“The publication of this paper provides broader and more comprehensive data support for the application of the COVID-19 oral drug Mindvy?, and once again proves the safety and efficacy of Mindvy?. The drug is now included in the National Health Insurance Catalog and has become one of the preferred drugs for the treatment of COVID-19 infection. In addition, VV116 is a potential broad-spectrum antiviral nucleoside drug, which has a good inhibitory effect on COVID-19 (SARS-CoV-2), respiratory syncytial virus (RSV), parainfluenza virus, dengue virus and other RNA viruses. Preclinical studies have shown that VV116 has a significant inhibitory effect on RSV and good safety. At present, the company has completed Phase I clinical research on VV116 RSV indication and is actively preparing for Phase II clinical research.In the future, Vigonvita will continue to dedicate itself to the research and development of antiviral drugs, so as to relieve more patients from their illnesses and contribute to the society.”