On December 3, 2025, Vigonvita Life Science Co., Ltd. (2630.HK, hereinafter referred to as “Vigonvita”) entered into a licensing and collaboration agreement with Simcere Pharmaceutical Group (2096.HK, hereinafter referred to as “Simcere”). Under this agreement, Vigonvita will grant Simcere the exclusive rights to develop, manufacture, and commercialize VV116 for respiratory syncytial virus (RSV) infection and human metapneumovirus (HMPV) infection in Greater China (including the Chinese mainland, Hong Kong Special Administrative Region, Macao Special Administrative Region, and Taiwan region).
Mr. Gaobo Zhou, Chief Investment Officer of Simcere, commented: “RSV affects people of all ages, and remains particularly harmful to infants, older adults, and individuals with weakened immune systems, for whom effective antiviral treatments are still limited. We are pleased to partner with Vigonvita to advance the development and commercialization of innovative antiviral therapies, with the hope of bringing more effective treatment options to patients as quickly as possible.”
Dr. Guanghui Tian, Chairman and General Manager of Vigonvita, stated: “The dry suspension formulation of deuterated remididevir hydrobromide has received Breakthrough Therapy Designation and is expected to become the world’s first nucleoside-based antiviral approved for RSV. This exclusive licensing collaboration with Simcere will accelerate the development of indications for RSV and HMPV, with the goal of making better treatment options available to patients sooner.”
Regarding the RSV Infection Indication for VV116
Results from a Phase II clinical trial showed that all three dose groups of VV116 (15 mg/kg BID, 20 mg/kg BID, 20 mg/kg TID) demonstrated favorable efficacy. In the VV116 treatment groups, the median time to disappearance of six core symptoms and signs (including intercostal retractions, decreased SpO₂, fever, feeding difficulties, abnormal mental status, and tachypnea) was significantly shortened, with hazard ratios (HR) all greater than 1, indicating a clear trend of clinical benefit. Viral load was significantly reduced, especially 72 hours after dosing, where the difference in viral load between the high-dose group (20 mg/kg TID) and the placebo group reached 1.3 log10 copies/mL. Improvements in clinical symptoms and signs, such as Wang bronchiolitis score, modified TAL score, and wheezing, were superior to those in the placebo group. Quantitative pharmacological exposure-response relationship analysis showed a downward trend in viral load and symptom scores with increasing exposure, with significant correlations observed at certain time points. Analysis using a quantitative systems pharmacology (QSP)-PK-PD model similarly indicated that as the dose increased, the variability in viral load among pediatric patients decreased markedly, and the high-dose group exhibited a significant acceleration in viral clearance.
Based on the positive results from this clinical trial, the VV116 dry suspension has been included in the breakthrough therapy designation by the Center for Drug Evaluation of the National Medical Products Administration.
VV116 is an orally administered nucleoside analog drug with broad-spectrum antiviral potential. It has already been approved for marketing in China (brand name: 民得维®) and Uzbekistan (brand name: Mindvy®) for the SARS-CoV-2 infection indication. In addition to RSV and SARS-CoV-2, VV116 also exhibits inhibitory effects against various RNA viruses, including human metapneumovirus (HMPV), Zika virus (ZIKV), and Nipah virus (NiV).
About Simcere
Simcere Pharmaceutical Group (2096.HK) is an innovation and R&D-driven pharmaceutical company, operating the “National Key Laboratory for Neurological and Oncology Drug Research.” The company focuses on the fields of neuroscience, oncology, autoimmune diseases, and anti-infectives, while proactively exploring future disease areas with significant clinical needs, fulfilling its corporate mission of “Born for Patients.” Driven by both independent R&D and collaborative innovation, Simcere has established strategic partnerships with numerous innovative enterprises and academic research institutions.
About Vigonvita
Vigonvita Life Science Co., Ltd. (2630.HK), founded in 2013, is an innovation-driven biopharmaceutical company committed to improving patient health and quality of life. It is dedicated to pioneering new drugs in the fields of neuropsychiatry, reproductive health, and viral infections. Vigonvita has established a fully integrated, end-to-end, and internally controlled functional system covering the entire industrial chain from innovative drug lead discovery, druggability evaluation, and preclinical research, to clinical studies, manufacturing, and commercialization, enabling the rapid and efficient translation of candidate new drugs from laboratory research to clinical application.