VIGONVITA-B (02630) announced that it has entered into a licensing agreement with SIMCERE PHARMA Group Limited (02096) for new indications of VV116. Under the agreement, VIGONVITA-B will grant SIMCERE PHARMA exclusive licensing rights for VV116 in the Greater China region to treat respiratory syncytial virus (RSV) and human metapneumovirus (HMPV) infections. The collaboration leverages the strengths of both companies in R&D, production, and commercialization to accelerate the clinical development and commercialization of VV116, aiming to benefit more patients.
VV116 is an oral novel nucleoside prodrug that received conditional approval from China's National Medical Products Administration (NMPA) in January 2023 for treating mild-to-moderate COVID-19 infections. In January 2025, this conditional approval was converted to full approval. Studies indicate that VV116 exhibits broad-spectrum antiviral activity, demonstrating strong inhibitory effects against multiple RNA viruses, including RSV.
For RSV treatment, a Phase II clinical trial of VV116 dry suspension for infants and young children with RSV infection has been completed. Based on positive results, the drug was designated as a Breakthrough Therapy by the Center for Drug Evaluation (CDE) under NMPA. Preclinical studies show that VV116 exhibits significant antiviral effects in vitro and in animal models while improving lung pathology. Clinical pharmacokinetic studies confirm its favorable oral absorption and linear pharmacokinetic properties, with infant formula showing no significant impact on the bioavailability of its primary metabolites. Clinical trials have demonstrated a favorable safety profile for VV116, with no serious adverse events reported.
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