On March 16, 2026, Simcere Pharmaceutical Group (2096.HK) announced that the Phase 3 clinical trial of deuremidevir hydrobromide dry suspension (development code: SIM0916) developed in collaboration with Vigonvita Life Science Co., Ltd. (2630.HK), has recently enrolled the first patient at Hunan Children’s Hospital for the treatment of respiratory syncytial virus (RSV) infection.
This multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial is jointly led by Academician Li Lanjuan of Shulan (Hangzhou) Hospital and Professor Liu Hanmin of West China Second University Hospital of Sichuan University. The trial plans to enroll 498 infants and toddlers aged 1-36 months with RSV-infection in 85 study centers nationwide.
RSV infects individuals of all ages, with particularly high risk among infants, older adults, and immunocompromised patients, and can readily cause acute lower respiratory tract infections. Currently, there are no widely approved antiviral therapies for RSV. Deuremidevir hydrobromide is an orally administered nucleoside analog with potential broad-spectrum anti‑RNA virus activity, exerting its antiviral effect by inhibiting viral RNA-dependent RNA polymerase (RdRp).
Phase 2 clinical trials in infants and toddlers with RSV infection demonstrated that deuremidevir hydrobromide dry suspension has favorable efficacy and safety.
This drug has received Breakthrough Therapy Designation for RSV infection from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). Previously, deuremidevir hydrobromide tablets have been approved in China for the treatment of mild to moderate COVID-19 in adults.
On December 3, 2025, Simcere entered into a licensing agreement with Vigonvita to obtain exclusive rights in Greater China for the development and commercialization of deuremidevir hydrobromide for the treatment of respiratory syncytial virus (RSV) infection and human metapneumovirus (HMPV) infection. Since then, Simcere has collaborated closely with partners and clinical researchers to expedite the advancement of clinical research, aiming to delivering more effective drugs to patients at the earliest opportunity.
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. Learn more at www.simcere.com.
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.