On March 16, 2026, the first patient in (FPI) of a Phase III clinical trial of deuterium hydrobromide ramidivir oral suspension (VV116 oral suspension), co-developed by Vigonvita Life Sciences Co., Ltd. (2630.HK, “Vigonvita”) and Simcere Pharmaceutical Group Limited (2096.HK, “Simcere”), for the treatment of respiratory syncytial virus (RSV) infection in infants and young children was dosed under the supervision of Principal Investigator Dr. Chen Yanping at Hunan Children’s Hospital.
This multicenter, randomized, double-blind, placebo-controlled Phase III study is led by Academician Li Lanjuan of Shulan (Hangzhou) Hospital and Professor Liu Hanmin, President of West China Second University Hospital of Sichuan University, as co-leading principal investigators. It plans to enroll 498 infants and young children aged 1–36 months with RSV infection at 85 research centers nationwide.
RSV can infect individuals of all age groups, particularly infants, the elderly, and immunocompromised individuals, often causing acute lower respiratory tract infections. To date, no specific antiviral therapy for RSV has been approved and marketed globally, leaving a long-standing unmet clinical need and heavy disease burden. VV116 exerts broad-spectrum anti-RNA virus activity by inhibiting viral RNA-dependent RNA polymerase (RdRp). Previous Phase II clinical study results showed that VV116 oral suspension demonstrated favorable efficacy and safety in infants and young children with RSV infection. Based on these positive findings, VV116 oral suspension was granted Breakthrough Therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).
Previously, the tablet formulation (VV116 tablets, trade name: Mindvy), jointly developed by the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences, Wuhan Institute of Virology of the Chinese Academy of Sciences, Xinjiang Technical Institute of Physics and Chemistry of the Chinese Academy of Sciences, Lingang Laboratory, Vigonvita, and Junshi Biosciences, has been routinely approved in China for the treatment of mild-to-moderate COVID-19 in adults. In addition to SARS-CoV-2 and RSV, VV116 has also demonstrated inhibitory activity against several other RNA viruses, including human metapneumovirus (HMPV), Nipah virus (NiV), and Zika virus (ZIKV).
In December 2025, Vigonvita and Simcere entered into a license and collaboration agreement, under which Vigonvita granted Simcere exclusive rights to develop and commercialize VV116 for the indications of respiratory syncytial virus (RSV) infection and human metapneumovirus (HMPV) infection in Greater China. Since then, Vigonvita, Simcere, and their partners and clinical investigators have worked closely together to rapidly advance the clinical study, with the goal of delivering benefits to patients and their families as soon as possible.
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About Vigonvita
Established in 2013, Vigonvita is an innovation-driven biopharmaceutical company committed to improving patients’ health and quality of life. The Company is dedicated to the development of novel drugs in the fields of neuropsychiatry, reproductive health and viral infection. Vigonvita has established an integrated functional and fully internally controlled system covering the whole industrial chain from lead discovery for innovative drugs, druggability evaluation, preclinical and clinical research to manufacturing and commercialization, thereby enabling the rapid and efficient transformation of candidate drugs from laboratory research to clinical application.
About Simcere
Simcere Pharmaceutical Group Limited（2096.HK） is a pharmaceutical company driven by innovation and focusing on four therapeutic areas including Neuroscience, Oncology, Autoimmune Diseases and Anti-infection. We proactively explore areas with significant unmet needs, and our mission is For patients, for life. Driven by our in-house R&D efforts and synergistic innovation, Simcere has established strategic cooperation partnerships with many innovative companies and research institutes.