Securities code: Shanghai Junshi Biosciences Co.Ltd(688180) securities abbreviation: Shanghai Junshi Biosciences Co.Ltd(688180) Announcement No.: pro 2022020 Shanghai Junshi Biosciences Co.Ltd(688180)
Voluntarily disclose the announcement on three phase I clinical data published by vv116. 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 liabilities 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”) were 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”) The results of three phase I clinical studies were published in actaphharmaceutica Sinica, a well-known journal in the pharmaceutical field. Professor Zhang Wenhong of Huashan Hospital Affiliated to Fudan University, researcher Wang Zhen of Shanghai Institute of pharmacy, Chinese Academy of Sciences, and director Liu Gangyi of Shanghai Xuhui District Central Hospital were the co communicators. The results showed that vv116 showed satisfactory safety and tolerance in healthy subjects, with rapid oral absorption. It can be administered orally under fasting or normal dietary conditions. It is recommended to explore the dose of 200 mg to 600 mg twice a day in subsequent clinical studies. This is the first phase I clinical data of domestic oral small molecule anti sars-cov-2 drugs. Due to the long research and development cycle and many approval links of drugs, it is vulnerable to some uncertain factors. The clinical research process, research results and approval results of vv116 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.
As of the announcement date, VV116 has been approved in Uzbekistan for the treatment of patients with moderate to severe New Coronavirus pneumonia (hereinafter referred to as “COVID-19”).
2、 Relevant information of clinical research
The three phase I clinical studies published by vv116 this time were mainly studied by Liu Gangyi, director and Yu Chen, director of Shanghai Xuhui District Central Hospital. Study 1 (nct05227768) and Study 2 (nct05201690) were randomized, double-blind, placebo-controlled, single dose and multi dose incremental studies to evaluate the safety, tolerance and pharmacokinetics of single and multiple incremental oral vv116 in healthy subjects. Study 3 (nct05221138) was a randomized, open, 3-cycle, crossover study, To observe the effects of diet on pharmacokinetics and safety of vv116 in healthy subjects. Between November 2021 and January 2022, a total of 86 eligible adult healthy subjects were included in the study, including 38 subjects in Study 1, 36 subjects in Study 2 and 12 subjects in Study 3. The results show that:
(I) vv116 was absorbed rapidly by oral administration;
(II) repeated administration can maintain the effective antiviral concentration;
(III) ordinary diet has no effect on vv116 drug exposure. It is recommended to take oral medicine on an empty stomach or under ordinary diet;
(Ⅳ) in terms of safety, vv116 showed satisfactory safety and tolerance in healthy subjects. None of the three studies reported death, serious adverse events (SAE), adverse events of grade 3 and above (AE), or adverse events leading to drug withdrawal and interruption of treatment. All adverse events recovered without treatment or intervention. Compared with the previously reported data of similar drugs, vv116 has a lower risk of hepatotoxicity.
Based on the positive results of the above phase I study, the company and Wangshan wangshui have launched an international multicenter, double-blind, randomized, placebo-controlled, phase II / III clinical study (nct05242042) for patients with mild to moderate covid-19. The study was conducted by Professor Zhang Wenhong of Huashan Hospital Affiliated to Fudan University and the five Central Asian countries in Shanghai public health clinic: 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.
Professor Xin Shen Yinzhong co chaired the study to evaluate the efficacy, safety and pharmacokinetics of vv116 in the early treatment of mild to moderate covid-19 patients. As of the disclosure date of this announcement, the study has completed the enrollment and administration of the first patient in Shanghai public health clinical center and is being carried out in many centers around the world. In addition, another international multicenter, randomized, double-blind, controlled phase III clinical study to evaluate the effectiveness and safety of vv116 compared with standard treatment in moderate and severe covid-19 subjects is in progress, and the first patient has been enrolled and administered. For details, see the company’s disclosure on the website of Shanghai Stock Exchange on March 16, 2022 (www.sse. Com. CN.) (Announcement No.: p.2022019).
3、 Risk tips
(I) due to the characteristics of high-tech, high-risk and high added value of pharmaceutical products, the long R & D cycle and many approval links of drugs are vulnerable to some uncertain factors. The process, results and approval results of this clinical research are uncertain.
(II) influenced by the global epidemic development and control, the popularization of relevant preventive vaccines, the successive approval of therapeutic drugs, the marketing of follow-up products and other factors, the commercialization of the drug in the future is 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 March 17, 2022
