The board of directors of Shanghai Junshi Biosciences Co., Ltd. announced that the results of the preclinical in vivo efficacy study of VV116 tablet ("VV116"), an oral nucleoside analog anti-SARS-CoV-2 drug jointly developed by Shanghai JunTop Biosciences Co., Ltd. ("JunTop Biosciences"), a subsidiary controlled by the Company, and Vigonvita Life Sciences Co., Ltd. ("Vigonvita") as a potent inhibitor of respiratory syncytial virus ("RSV") was published online in Signal Transduction and Targeted Therapy (STTT, IF: 18.187), a journal under Nature . The study shows that VV116 has excellent antiviral activity against multiple RSV sensitive cell lines. In the mouse model, VV116 exhibited high oral bioavailability, good tissue distribution and significantly better antiviral effect than ribavirin, and can alleviate the pathological damage of lung tissue.

This study provides a valuable clinical candidate for the treatment of RSV infection. 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, and had antiviral activity against both the original strain of SARSCoV-2 and the known important variants (Alpha, Beta, Delta and Omicron), and also exhibited high oral bioavailability and good chemical stability. VV116 is jointly developed by Shanghai Institute of Materia Medica, Chinese Academy of Sciences, 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 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 the Company.

In September 2021, JunTop Biosciences entered into a cooperative development agreement with Vigonvita to jointly undertake the clinical development and commercialization of VV116 in the cooperation territory, being the whole world except for the following four territories, namely the 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 showed good safety, tolerability and pharmacokinetics in healthy subjects, and the three phase I clinical study results have been published online in Acta Pharmacologica Sinica, a renowned journal in the pharmaceutical field. In 2021, a randomized, open-label, controlled phase II clinical trial of VV116 was completed in subjects with moderate to severe coronavirus disease 2019 ("COVID-19") in Uzbekistan.

The study showed that, in comparison with the control group, the VV116 arms could better improve the clinical symptoms of patients, shorten the time taken to get a negative result of SARS-CoV-2 nucleic acid test, and significantly reduce the risk of critical illness and death. Based on the positive results of this trial, VV116 has been approved in Uzbekistan for the treatment of patients with moderate to severe COVID-19. Currently, VV116 is under the stage of international multi-center phase III clinical studies, and several clinical studies for patients with mild to moderate and moderate to severe COVID-19 are in progress.

The preclinical in vivo efficacy study was jointly completed by the team of Xiao Gengfu/Zhang Leike at the Wuhan Institute of Virology, Chinese Academy of Sciences/State Key Laboratory of Virology and the team of Shen Jingshan/Xie Yuanchao at the Shanghai Institute of Materia Medica, Chinese Academy of Sciences. Zhang Ruxue and Zhang Yumin, a postgraduate fellow and a postdoctoral fellow at the Wuhan Institute of Virology, Chinese Academy of Sciences respectively, and Zheng Wei, a doctoral candidate at the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, are the co-first authors. Researcher Xie Yuanchao of Lingang Laboratory and researcher Zhang Leike of Wuhan Institute of Virology, Chinese Academy of Sciences are the co-corresponding authors.

RSV is a single-stranded, negative-stranded unsegmented RNA virus belonging to the Paramyxoviridae family, the genus Pneumovirus. Infection with such virus often leads to respiratory diseases such as bronchiolitis and pneumonia in infants under 6 months of age, and symptoms such as rhinitis and colds in older children and adults. RSV infection in the elderly can lead to serious complications, such as chronic obstructive pulmonary disease and congestive heart failure.

As of the date of this announcement, there is no safe and effective drug for the treatment of RSV infection on the market globally, resulting in huge unmet medical needs for a long time. The published in vivo efficacy study provides strong evidence for the potential therapeutic effect of VV116 on RSV infection, which will be validated in later clinical studies.