Securities code: Shanghai Junshi Biosciences Co.Ltd(688180) securities abbreviation: Shanghai Junshi Biosciences Co.Ltd(688180) Announcement No.: pro 2022037 Shanghai Junshi Biosciences Co.Ltd(688180)
Voluntary disclosure of information on vv116 as a potential RSV inhibitor
Announcement of preclinical in vivo efficacy research results
The board of directors and all directors of the company guarantee that there are no false records, misleading statements or major omissions in the contents of this announcement, and bear legal responsibility for the authenticity, accuracy and integrity of its contents according to law.
Recently, The oral nucleoside anti SARS cov-2 drug vv116 tablets (hereinafter referred to as “vv116”) jointly developed by Shanghai juntuo Biomedical Technology Co., Ltd. (hereinafter referred to as “juntuo biology”), a holding subsidiary of Shanghai Junshi Biosciences Co.Ltd(688180) (hereinafter referred to as “the company”), and Suzhou Wangshan wangshui biomedical Co., Ltd. (hereinafter referred to as “Wangshan wangshui”) are used as potential respiratory syncytial virus (hereinafter referred to as “RSV”) The research results of preclinical and in vivo efficacy of inhibitors are published online in nature’s publication signal transduction and targeted therapy (STTT, if: 18.187). It was found that vv116 had excellent antiviral effect on multiple RSV sensitive cell lines. In the mouse model, vv116 has 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. Due to the long research and development cycle and many approval links of drugs, they are vulnerable to some uncertain factors. The follow-up clinical research process, research results and approval results are uncertain. Please make careful decisions and pay attention to preventing investment risks. The relevant information is hereby announced as follows:
1、 Basic information of drugs
Vv116 is a new oral nucleoside anti sars-cov-2 drug, which can inhibit the replication of sars-cov-2. Preclinical studies showed that vv116 showed significant anti sars-cov-2 effect in vivo and in vitro. It showed antiviral activity against the original strain of sars-cov-2 and known important variants (alpha, beta, Delta and Omicron), and had high oral bioavailability and good chemical stability.
China China one belt, one road China’s VV116 Research Center, Wuhan Institute of Chinese Academy of Sciences, Xinjiang Institute of physical and chemical technology, Chinese Academy of Sciences, Central Asian drug research and development center of Chinese Academy of Sciences, China and Ukraine medical science and Technology City (Ministry of science and technology “one belt and one road” Joint Laboratory), Wang Shan Wang Shui and the company jointly developed and developed the technology of the “VV116”. In September 2021, juntuo biological entered into a cooperative development contract with Wangshan wangshui to jointly undertake the clinical development and industrialization of vv116 in the cooperation area. The cooperation area is global except five Central Asian countries 1, Russia, North Africa 2 and the Middle East.
Vv116 showed good safety, tolerance and pharmacokinetics in healthy subjects. The results of three phase I clinical studies have been published online in actapharmacologica Sinica, a well-known journal in the pharmaceutical field. In 2021, VV116 completed a randomized, open, and controlled II phase clinical trial in Uzbekistan with moderate to severe New Coronavirus pneumonia (COVID-19). The results showed that compared with the control group, the VV116 group could better improve the clinical symptoms, shorten the time of SARS-CoV-2 negative conversion, and significantly reduce the risk of progression to critical illness and death. Based on the positive results of this trial, vv116 has been approved in Uzbekistan for the treatment of moderate and severe covid-19 patients. At present, vv116 is in the phase III clinical research stage of international multi center, and a number of clinical studies for mild, moderate and severe covid-19 patients are in progress.
2、 Relevant information of preclinical in vivo pharmacodynamic study
The preclinical in vivo efficacy study was jointly completed by Xiao Gengfu / Zhang LEIYU team of Wuhan Institute of virology / State Key Laboratory of Virology, Chinese Academy of Sciences, and Shen Jingshan / Xie Yuanchao team of Shanghai Institute of pharmacy, Chinese Academy of Sciences. Zhang Ruxue, a master’s student of Wuhan Institute of Virology, Chinese Academy of Sciences, Zhang Yumin, a postdoctoral student, and Zheng Wei, a doctoral student of Shanghai Institute of medicine, are the co first authors, while Xie Yuanchao, a researcher of Lingang laboratory and Zhang LEIYU, a researcher of Wuhan Institute of Virology, Chinese Academy of Sciences, are the co communication authors.
Respiratory syncytial virus (RSV) is a single stranded, negative chain non segmented RNA virus belonging to Paramyxoviridae and pulmonary virus. Infection with the virus often leads to respiratory diseases such as bronchiolitis and pneumonia in infants under 6 months old. Infection in older children and adults can lead to symptoms such as rhinitis and cold. Infection with RSV in the elderly can lead to serious complications, such as chronic obstructive pulmonary disease and congestive heart failure. As of the disclosure date of this announcement, there is no safe and effective RSV infection treatment drug on the market worldwide, and there is a huge unmet clinical demand for a long time. The published in vivo pharmacodynamic study provides strong evidence for the potential therapeutic effect of vv116 on RSV infection, which will be verified in later clinical studies. 1. The five Central Asian countries refer to Kazakhstan, Uzbekistan, Kyrgyzstan, Tajikistan and Turkmenistan. 2 North Africa: refers to Egypt, Libya, Tunisia, Algeria, Morocco and Sudan. 3 Middle East: refers to Saudi Arabia, Iran, Iraq, Kuwait, UAE, Oman, Qatar, Bahrain, Turkey, Israel, Palestine, Syria, Lebanon, Jordan, Yemen, Cyprus, Georgia, Armenia and Azerbaijan.
3、 Risk tips
Because pharmaceutical products have the characteristics of high technology, high risk and high added value, the drug R & D cycle is long, there are many approval links, and they are vulnerable to some uncertain factors. The follow-up clinical research process, research results and approval results are uncertain.
The company will actively promote the above R & D projects with Wangshan wangshui, and timely perform the obligation of information disclosure on the follow-up progress of the project in strict accordance with relevant regulations. Please make careful decisions and pay attention to preventing investment risks. The information about the company shall be subject to the announcements published by the designated disclosure media of the company, such as China Securities News, Shanghai Securities News, securities times, securities daily and the website of Shanghai Stock Exchange.
It is hereby announced.
Shanghai Junshi Biosciences Co.Ltd(688180) board of directors April 18, 2022
