VV116 Versus PAXLOVID Phase III Registrational Trial for Early Treatment of Mild to Moderate COVID-19 in High Risk Patients Reaches Primary Endpoint

--the study reached its primary endpoint(VV116 was statistically superior) and secondary efficacy endpoint

--VV116 has a favorable safety profile and fewer adverse events than PAXLOVID

SHANGHAI, China, May 25, 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 Phase III clinical study (NCT05341609) comparing the efficacy and safety of VV116 (JT001) and nirmatrelvir/ritonavir ("PAXLOVID”) in the treatment of patients with mild to moderate COVID-19 who are at high risk for progression to severe COVID-19 including death, has reached its pre-specified primary endpoint and secondary efficacy endpoint. The study results show that compared to PAXLOVID, VV116 (JT001) provided patients with a shorter median time to sustained clinical recovery, achieving statistical superiority.

VV116 (JT001) is a new oral nucleoside analog anti-SARS-CoV-2 investigational drug jointly developed by Junshi Biosciences and Vigonvita Life Sciences Co., Ltd ("Vigonvita”). In earlier Phase I trials, VV116 (JT001) exhibited good safety, tolerability, and pharmacokinetics in healthy subjects. At present, the double-blind, placebo-controlled, international multiregional center Phase III trial evaluating VV116 for the treatment of mild to moderate COVID-19 who are at high risk for progression to severe COVID-19 including death is underway, and a number of clinical studies for mild, moderate and severe COVID-19 are also in progress.

The NCT05341609 study is a multicenter, single-blind, randomized, controlled Phase III study evaluating the efficacy and safety of VV116 (JT001) in comparison with PAXLOVID in the early treatment of patients with mild to moderate COVID-19 who are at high risk for progression to severe COVID-19 and death. The trial was conducted after communication with regulatory authorities. A total of 822 patients were enrolled and a single-blind design was adopted so as to conceal the distribution of therapeutic drugs to both the investigators (including the endpoint evaluator) and the study sponsor. The primary endpoint was "time to sustained clinical recovery,” and the secondary endpoints included "percentage of participants who had progression of COVID-19 (defined as progression to severe and/or critical COVID-19 and death from any cause) by Day 28,” "time to sustained disappearance of clinical symptoms,” "percentage of participants who turned negative for SARS-CoV-2,” etc.

The results of this Phase III study, evaluating VV116 (JT001) as a treatment for patients with mild to moderate COVID-19 who are at high risk for progression to severe COVID-19 and death, show that the predetermined primary endpoint has been reached. In comparison with patients in the PAXLOVID arm, those in the VV116 (JT001) arm exhibited a shorter time to sustained clinical recovery and achieved statistical superiority, a result that demonstrates VV116’s (JT001) ability to accelerate the alleviation of COVID-19 symptoms.

In terms of the secondary efficacy endpoints, there were no COVID-19 disease progression or death in the VV116 (JT001) arm or PAXLOVID arm. The research team also observed that VV116 (JT001) showed a trend toward superiority to PAXLOVID in the time to sustained disappearance of clinical symptoms and the time to patient testing negative for SARS-CoV-2 for the first time.

As for safety, VV116 (JT001) has a good safety profile and its overall incidence of adverse events ("AE”) is lower than that of PAXLOVID.

Detailed data will be published by Junshi Biosciences in a medical journal at a later date.

About VV116 (JT001)
VV116 is an oral nucleoside analog drug that can inhibit the replication of SARS-CoV-2. During preclinical pharmacodynamic studies, VV116 exerted an antiviral effect on the original strain of the novel corinavirus and its known variants in vitro; in the mice model, a low dose of VV116 reduced the virus titers below the detection limit, significantly lowered the chances of lung injury and displayed a strong antiviral effect. Preclinical pharmacokinetics and other research results also show that VV116 has high oral bioavailability. Following oral administration and absorption, VV116 is rapidly metabolized into parent nucleoside and widely distributed throughout the body.

VV116 was jointly developed by the Shanghai Institute of Materia Medica, Chinese Academy of Sciences; the 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 Chinese Academy of Sciences / China-Uzbekistan Medicine Technical Park (the Joint Laboratory of the Ministry of Science and Technology under the "The Belt and Road Initiative"); Vigonvita Life Sciences Co., Ltd. ("Vigonvita”); and Junshi Biosciences. Junshi Biosciences and Vigonvita are responsible for the clinical development and industrialization of VV116 worldwide. The areas of cooperation is global aside from five Central Asian countries, Russia, North Africa and the Middle East.

Junshi Biosciences and Vigonvita have completed three Phase I studies with healthy Chinese subjects, and research results have been published in Acta Pharmacologica Sinica, a well-known journal in the pharmaceutical field. VV116 is currently in an international, multicenter Phase III trial, and a number of clinical studies for mild, moderate and severe COVID-19 are in progress.

In 2021, VV116 was approved in Uzbekistan for the treatment of patients diagnosed with moderate to severe COVID-19.

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 50 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 monoclonal antibody for tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and has since entered Phase Ib/II trials in both China and the US. Its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA.

In the face of the pandemic, Junshi Biosciences’ response was strong and immediate, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to combat COVID-19, taking the initiative to shoulder the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. Among the many drug candidates is JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2 and the result of the combined efforts of Junshi Biosciences, the Institute of Microbiology of the Chinese Academy of Science and Lilly. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations ("EUA”) in over 15 countries and regions worldwide. Meanwhile, VV116, a new oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, is in global Phase III clinical trials. The JS016 and VV116 programs are a part of the company’s continuous innovation for disease control and prevention of the global pandemic.

Junshi Biosciences has more than 2,800 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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