SHANGHAI, China, January 30, 2023 (GLOBE NEWSWIRE) – Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today that the National Medical Products Administration (the “NMPA”) has conducted urgent review and approval under Special Examination and Approval of Drugs, and conditionally approved for marketing Deuremidevir Hydrobromide Tablets (project code: JT001/VV116, “VV116”), an oral nucleoside analog anti-SARS-CoV-2 drug, for the treatment of adult patients with mild to moderate coronavirus disease 2019 (“COVID-19”).
VV116 is a new oral nucleoside analog antiviral drug, which can be non-covalently bound to the active center of RNA-dependent RNA polymerase (“RdRp”) of SARS-CoV-2 in the form of nucleoside triphosphate, directly inhibiting the activity of RdRp of the virus and blocking the replication of virus, thus realizing the antiviral effect. Preclinical studies have shown that VV116 exhibited significant antiviral effects against both the original COVID-19 strain and mutant strains, including Omicron, and exhibited no genetic toxicity.
VV116 was jointly developed by the Shanghai Institute of Materia Medica at the Chinese Academy of Sciences, Wuhan Institute of Virology at the Chinese Academy of Sciences, Xinjiang Technical Institute of Physics and Chemistry at the Chinese Academy of Sciences, Central Asian Center of Drug Discovery and Development of Chinese Academy of Sciences) / China-Uzbekistan Medicine Technical Park (“the Belt and Road” Joint Laboratory of the Ministry of Science and Technology), Lingang Laboratory, Vigonvita Life Sciences Co., Ltd. (“Vigonvita”) and Junshi Biosciences
This approval is mainly based on a multi-center, double-blind, randomized, placebo-controlled phase III clinical study (NCT05582629) evaluating the efficacy and safety of VV116 among mild to moderate COVID-19 patients with or without high risk of progression to severe COVID-19. The study was led by academician Lanjuan LI, Director of the State Key Laboratory for Diagnosis & Treatment of Infectious Diseases (Zhejiang University) as primary investigator. The primary endpoint of the study was the time to sustained clinical symptoms resolution, while the secondary endpoints included the time to sustained clinical symptoms alleviation, percentage of participants with disease progression to severe or critical COVID-19 or death by any cause by day 28, changes in SARS-CoV-2 nucleic acid and viral load, safety, and etc. The study results showed that as of the data cut-off date of the interim analysis, among 1,277 randomized and treated subjects, the primary endpoint, or the time from first administration to sustained clinical symptoms resolution (The score of 11 COVID-19 related clinical symptom =0 and lasted for 2 days) of the VV116 group was significantly shortened when compared with that of the placebo group, and the median time difference was 2 days; similarly, the time to sustained clinical symptoms alleviation was also significantly shortened, and the change of viral load from baseline and other virological indicators were better than those of the placebo group.
About Deuremidevir Hydrobromide Tablets (VV116/JT001)
VV116 is an oral nucleoside analog drug that can inhibit the replication of SARS-CoV-2. During preclinical pharmacodynamic studies, VV116 exerted an antiviral effect on the original strain of the novel corinavirus and its known variants in vitro; in the mice model, a low dose of VV116 reduced the virus titers below the detection limit, significantly lowered the chances of lung injury and displayed a strong antiviral effect. Preclinical pharmacokinetics and other research results also show that VV116 has high oral bioavailability. Following oral administration and absorption, VV116 is rapidly metabolized into parent nucleoside and widely distributed throughout the body.
VV116 was jointly developed by the Shanghai Institute of Materia Medica, Chinese Academy of Sciences; the Wuhan Institute of Virology, Chinese Academy of Sciences; Xinjiang Technical Institute of Physics and Chemistry, Chinese Academy of Sciences; Central Asian Center of Drug Discovery and Development Chinese Academy of Sciences / China-Uzbekistan Medicine Technical Park (the Joint Laboratory of the Ministry of Science and Technology under the “The Belt and Road Initiative”); Lingang Laboratory; Vigonvita Life Sciences Co., Ltd. (“Vigonvita”); and Junshi Biosciences. Junshi Biosciences and Vigonvita are responsible for the clinical development and industrialization of VV116 worldwide. The areas of cooperation is global aside from five Central Asian countries, Russia, North Africa and the Middle East.
Junshi Biosciences and Vigonvita have completed three Phase I studies with healthy Chinese subjects, and one Phase III study in the patients with mild-to moderate COVID-19 at high risk to progression to severe COVID-19 in China (NCT05341609). Research results have been published in Acta Pharmacologica Sinica, and NEJM respectively. Aside from that, one Phase III study in the patients with or without high risk of progression to severe COVID-19 has completed its pre-specified interim analysis, and met the pre-defined primary efficacy endpoint.
In December 2021, VV116 was approved in Uzbekistan for the treatment of patients diagnosed with moderate to severe COVID-19. In January 2023, VV116 was approved for marketing in China for the treatment of adult patients with mild to moderate COVID-19.