Core Viewpoint - The company has entered into a licensing agreement with Ascletis Pharma Inc. for the exclusive rights to develop and commercialize VV116 for RSV and HMPV infections in Greater China, aiming to accelerate clinical development and commercialization to benefit more patients [1][2]. Group 1: Licensing Agreement - The company grants Ascletis exclusive licensing rights for VV116 in the treatment of RSV and HMPV infections in Greater China [1]. - This collaboration leverages the strengths of both companies in research, production, and commercialization [1]. Group 2: Product Overview - VV116 is an oral nucleoside prodrug that received conditional approval from the National Medical Products Administration (NMPA) in January 2023 for treating mild to moderate COVID-19 infections, with plans for full approval by January 2025 [1]. - VV116 exhibits broad-spectrum antiviral activity, showing effective inhibition against various RNA viruses, including RSV [1]. Group 3: Clinical Trials and Safety - A Phase II clinical trial for VV116 as a treatment for RSV in infants has been completed, leading to its designation as a breakthrough therapy by the NMPA [2]. - Preclinical studies indicate significant antiviral effects of VV116 in vitro and in animal models, along with improvements in lung pathology [2]. - Clinical pharmacokinetic studies demonstrate good oral absorption and linear pharmacokinetics, with no significant impact from infant formula on its main metabolites [2]. - Overall safety in clinical studies is reported to be good, with no severe adverse events noted [2].
旺山旺水-B与先声药业就VV116新适应症订立许可协议