Securities code: Shanghai Junshi Biosciences Co.Ltd(688180) securities abbreviation: Shanghai Junshi Biosciences Co.Ltd(688180) Announcement No.: pro 2022045 Shanghai Junshi Biosciences Co.Ltd(688180)
About vv116 vs paxlovid early treatment mild to moderate
Announcement that the phase III registered clinical study of covid-19 has reached the primary end point
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 (project code: jt001 / vv116, 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 in a comparison of binematevir tablets / ritonavir tablets (paxlovid) the phase III registered clinical study (nct05341609) for the early treatment of mild to moderate novel coronavirus pneumonia (hereinafter referred to as “covid-19”) reached the primary endpoint of the protocol. The company will communicate with the regulatory authorities on the submission of new drug listing applications in the near future.
Due to the long R & D cycle and many approval links of drugs, they are vulnerable to some uncertain factors. Please make careful decisions and pay attention to preventing investment risks. The relevant information is hereby announced as follows:
1、 Basic information of drugs
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, tolerability and pharmacokinetics in healthy subjects. The results of three phase I clinical studies have been published online in actapharmacologica1, a well-known journal in the pharmaceutical field. 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.
Sinica。 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、 Clinical trial progress (nct05341609)
Nct05341609 study is a multicenter, single blind, randomized, controlled phase III clinical study to evaluate the efficacy and safety of vv116 in the early treatment of patients with mild to moderate covid-19. Ning Guang, academician of Ruijin Hospital Affiliated to the Medical College of Shanghai Jiaotong University, served as the main investigator of the study. 822 patients were actually enrolled. The primary endpoint was “time to continuous clinical recovery”, and the secondary endpoint included “percentage of subjects with covid-19 progression (defined as severe / critical covid-19 or all-cause death) by the 28th day”.
The results of this clinical study showed that vv116 for the early treatment of mild to moderate covid-19 reached the primary endpoint preset by the clinical protocol.
According to the requirements of laws and regulations related to drug registration in China, drugs can only be produced and put on the market after completing clinical research and being reviewed and approved by the State Food and drug administration. The company will communicate with the drug regulatory authorities on the submission of new drug listing applications in the near future.
3、 Risk tips
(I) due to the characteristics of new drug research and development, such as long cycle, high risk and high added value, and many approval links, it is vulnerable to some uncertain factors, and the approval conclusion is uncertain.
(II) influenced by the global epidemic development and control, the popularization of relevant preventive vaccines, the successive approval of therapeutic drugs, the market promotion of follow-up products and other factors, the commercial promotion of the drug in the future is also uncertain. The company will actively promote the above R & D projects 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 may 24, 2022
