On August 27, 2024, Vigonvita Shanghai Co., Ltd., Shanghai Institute of Materia Medica Chinese Academy of Sciences, the Wuhan Institute of Virology Chinese Academy of Sciences, and Vigonvita Life Sciences Co., Ltd. (“Vigonvita”) received the Drug Clinical Trial Approval Notice approved and issued by the National Medical Products Administration (NMPA), permitting the initiation of clinical trials for VV261 tablets for the treatment of Severe Fever with Thrombocytopenia Syndrome (SFTS) caused by infection with the novel Bunyavirus (SFTSV).
SFTSV is an enveloped, negative-sense, single-stranded RNA virus that can infect humans and cause Severe Fever with Thrombocytopenia Syndrome. In severe cases, the disease can lead to death due to hemorrhage or multiple organ failure. SFTSV infection cases have been reported in China, Japan, South Korea, and Vietnam, with a fatality rate of around 7.8%. Currently, there are no approved therapeutic drugs available globally for the treatment of SFTSV infection.
VV261 is a novel, orally administered nucleoside analog candidate drug with independent intellectual property rights. Preclinical research results have shown that VV261 exhibits significant antiviral efficacy in mouse models infected with SFTSV, and it demonstrates high oral bioavailability.
Dr. Tian Guanghui, General Manager of Vigonvita, stated: “VV261 is the first domestically developed small molecule candidate new drug in China to receive clinical trial approval for the treatment of SFTSV infection. It is expected to fill the gap in this treatment area, marking another new achievement for Vigonvita in the R&D of innovative drugs for infectious diseases. We will expedite the development progress of VV261 to meet clinical needs as soon as possible.”