SHANGHAI, China, March 16, 2022 (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 first patient was dosed in its Phase III trial of VV116 for the treatment of moderate to severe COVID-19. The study is an international multicenter, randomized, double-blind, controlled Phase III study to evaluate the efficacy and safety of VV116 against standard therapy in subjects with moderate to severe COVID-19. The primary endpoint is the percentage of patients who progress to critical/severe COVID-19 patients or all-cause mortality within 29 days. VV116 is an oral nucleoside analog anti-SARS-CoV-2 investigational drug jointly developed by Junshi Biosciences and Vigonvita Life Sciences Co., Ltd. (“Vigonvita”).
In addition, Junshi Biosciences has also initiated an international multi-center, double-blind, randomized, placebo-controlled, phase II/III clinical study (NCT05242042) with Vigonvita, which aims to evaluate the efficacy, safety and pharmacokinetics of VV116 in the early treatment of mild to moderate COVID-19 patients. The primary endpoint is the percentage of patients who progress to critical/severe COVID-19 patients or all-cause mortality within 29 days. First patient of the study has been enrolled and dosed in China, and the study is being conducted in multiple centers around the world.
Junshi Biosciences and Vigonvita have completed three Phase I studies evaluating the safety, tolerability, and pharmacokinetics of VV116 in healthy Chinese subjects, with preliminary results showing good clinical safety. In addition, a randomized, open-label, controlled Phase II clinical trial of VV116 was completed in subjects with moderate to severe COVID-19 in Uzbekistan in 2021, which enrolled a total of about 450 subjects. Subjects were divided into two VV116 groups (200mg and 300mg doses of VV116 orally, twice daily for 5 days) and one control group of standard therapy, with each group of about 150 subjects. The results of the study indicate that the two different doses of VV116 showed favorable safety and efficacy in the treatment of both moderate and severe COVID-19 patients, in comparison with standard therapy. Based on the positive results, VV116 has been approved for the treatment of moderate to severe COVID-19 patients in Uzbekistan in late 2021.
VV116 is a new oral nucleoside analog anti-SARS-CoV-2 drug that inhibits the replication of SARS-CoV-2. Preclinical studies have shown that VV116 exhibited significant anti-SARS-CoV-2 effects in vivo and in vitro, had antiviral activity against both the original strain of SARS- CoV-2 and the major known variants (Alpha, Beta, Delta, and Omicron), and exhibited high oral bioavailability and good chemical stability.
VV116 is jointly developed by three institutes of the Chinese Academy of Sciences (Shanghai Institute of Materia Medica, Wuhan Institute of Virology, and Xinjiang Technical Institute of Physics and Chemistry), 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), Vigonvita, and Junshi Biosciences. In September 2021, Junshi Biosciences entered into a collaboration with Vigonvita to jointly undertake the clinical development and commercialization of VV116 in the cooperation territory (worldwide except five Central Asian countries (Kazakhstan, Uzbekistan, Kyrgyzstan, Tajikistan, Turkmenistan), Russia, North Africa (Egypt, Libya, Tunisia, Algeria, Morocco, Sudan), and the Middle East (19 countries including Saudi Arabia, Iran, Iraq, Turkey, Israel, etc.)).
VV116 has been approved for treatment of moderate to severe COVID-19 patients in Uzbekistan.
About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising over 45 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology of Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in more than 15 countries and regions worldwide. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.
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