Junshi Biosciences
SHANGHAI, China, Dec. 29, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a starring innovation-driven biopharmaceutical institution dedicated to the discovery, development, and commercialization of caller therapies, contiguous announces the online work successful New England Journal (NEJM) of the Phase 3 proceedings (NCT05341609) comparing the efficacy and information of VV116 (JT001) and nirmatrelvir/ritonavir (“PAXLOVID”) successful the attraction of symptomatic patients with mild to mean COVID-19 who are astatine precocious hazard for progression to terrible COVID-19 including death. It is the archetypal clip that NEJM published the objective proceedings results of China-developed anti-SARS-CoV-2 drug.
The study, led by Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, is the archetypal “head-to-head” signifier III objective survey of tiny molecule oral anti-SARS-CoV cause successful Chinese COVID-19 patients during the Omicron outbreak. The results indicated that the superior endpoint of the survey realized the designed noninferiority endpoint, and VV116 radical had a shorter clip to sustained objective betterment with little information concerns arsenic compared with PAXLOVID.
The Article was co-authored by Professor Ren ZHAO of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Professor Yuan GAO of Renji Hospital, Shanghai Jiao Tong University School of Medicine, Professor Guang NING, Professor Yiping XU and Professor Qing XIE of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine arsenic co-corresponding authors, Zhujun CAO and Weiyi GAO of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Hong BAO of Pudong Hospital, Fudan University, Haiyan FENG of Shanghai Public Health Clinical Center and Shuya MEI of Renji Hospital, Shanghai Jiao Tong University School of Medicine arsenic co-first authors.
"Thanks to the enactment of the patients and survey team, we person achieved large occurrence successful this objective survey and were recognized by the prestigious New England Journal of Medicine,” said Professor Ren ZHAO. “Our survey not lone provided invaluable accusation and acquisition for the improvement and objective exertion of 2 large anti-SARS-CoV-2 tiny molecule cause routes, the RdRp inhibitor and the 3CL protease inhibitor, but besides showed that our self-developed anti-SARS-CoV-2 oral drugs successful China person akin efficacy and information to PAXLOVID. We anticipation that our survey results tin assistance successful our nation’s efforts to combat the epidemic.”
"Presently, the attraction and prevention of COVID-19 is inactive afloat of challenges, peculiarly successful the attraction of patients who are astatine precocious hazard for progression to terrible COVID-19," said Jianjun ZOU, Global Research and Development President astatine Junshi Biosciences. "The existent attraction needs to beryllium made much wide applicable and accessible to a larger population. The work of this survey successful the NEJM demonstrates that the planetary world assemblage has recognized the objective improvement of drugs led by Chinese investigators and pharmaceutical companies successful presumption of proceedings design, quality, and results. We are continuing to put successful the objective improvement of VV116 for usage successful different populations, with the extremity of providing amended and safer attraction options for COVID-19 patients successful China and astir the satellite with this breathtaking caller therapy!"
At present, the COVID-19 pandemic continues to dispersed rapidly worldwide, and the transmission and flight quality of the microorganism continues to summation with variation. Oral antiviral drugs are considered to beryllium 1 of the indispensable effect against the pandemic due to the fact that of their advantages of convenient administration, precocious absorption barrier, and little proscription and retention restrictions, which assistance to alleviate the aesculapian burden. However, determination are inactive a fig of factors that pb to constricted usage of the drugs (such arsenic the enactment betwixt cause and drug, accessibility, etc.), truthful much effectual and harmless therapeutic drugs request to beryllium developed.
VV116 is an oral nucleoside antiviral cause independently developed successful China that inhibits the replication of SARS-CoV-2. Preclinical studies person shown that VV116 had important antiviral effects successful some archetypal strain and known mutant strains, and exhibited satisfactory safety, tolerability, and pharmacokinetic properties successful signifier I objective studies1. A preliminary small-scale survey confirmed that patients, who were treated with VV116 wrong 5 days since they were tested affirmative aft the archetypal SARS-CoV-2 detection, had a shorter clip to nucleic acerb reversion compared to accepted therapy2.
This work is related to a multicenter, single-blind (observers stay blinded), randomized, controlled Phase III objective proceedings (NCT05341609) conducted jointly astatine 7 COVID-19 designated hospitals successful Shanghai from April 4 to May 2, 20223, which included a full of 822 big patients with mild to mean COVID-19 diagnosed astatine precocious hazard of progression and assigned to the VV116 radical and PAXLOVID radical connected a proportionality of 1:1. Finally, a full of 771 patients (Full Analysis Set, FAS) were treated with VV116 (n = 384) oregon PAXLOVID (n = 387).
Among them, the median property of FAS patients was 53 (range: 18-94), 50.2% of them were female, 92.1% of them had mild COVID-19, 75.7% of them were afloat vaccinated oregon boosted, and 77.3% of them received VV116 oregon PAXLOVID therapy wrong 5 days aft grounds onset. The astir communal high-risk factors successful patients were: property ≥ 60 years (37.7%), cardiovascular illness including hypertension (35.1%), obesity oregon overweight BMI ≥ 25 (32.9%), existent smoking (12.5%), and diabetes (10.1%).
The superior extremity constituent of the survey was the clip from randomization to sustained objective recovery, with a little bound of the two-sided 95% assurance interval (CI) for the hazard ratio (HR) > 0.8 defined arsenic noninferiority. Secondary efficacy extremity points included the proportionality of patients who progressed to terrible oregon captious COVID-19 oregon decease from immoderate origin by Day 28, the alteration successful COVID-19 related grounds people and the people connected the WHO Clinical Progression Scale, clip to sustained solution of each people symptoms, and to a archetypal antagonistic SARS-CoV-2 test. Safety endpoints included adverse events (AEs) and superior adverse events (SAEs).
According to the last investigation (as of August 18, 2022), VV116 and PAXLOVID achieved noninferiority successful the “time to sustained objective recovery” successful the FAS colonisation (HR = 1.17, 95% CI: 1.02~1.36), and the median clip to sustained objective betterment was shorter successful the VV116 radical than that successful the PAXLOVID radical (4 days vs. 5 days).
For VV116 radical and PAXLOVID group, they showed akin results successful respect of “time to sustained solution of each people symptoms” and “time to a archetypal antagonistic SARS-CoV-2 test”, with a median clip of 7 days. At each preset clip constituent (Days 5, 7, 10, 14, and 28), the proportionality of patients with objective betterment was larger successful the VV116 radical than that successful the PAXLOVID group. No patients successful either radical hase progression to severe/critical COVID-19 oregon had died.
In addition, astir 3/4 of the patients successful this survey had vaccinated against SARS-CoV-2, and specified patients person been excluded from astir trials, and subgroup investigation showed that determination was nary statistically important quality successful the attraction results betwixt VV116 and PAXLOVID successful the vaccinated oregon unvaccinated population.
VV116 showed less information interest than PAXLOVID. The incidence of AEs successful VV116 radical was little than that successful the PAXLOVID radical (all-grade AEs: 67.4% vs. 77.3%, Grade 3 oregon 4 AE: 2.6% vs. 5.7%).
It should beryllium noted that PAXLOVID has aggregate drug-drug interactions, portion VV116 does not inhibit oregon induce large drug-metabolism enzymes, oregon inhibit large cause transporters, and is truthful little apt to interact with the drugs for operation therapy.
About VV116 (JT001)
VV116 is an oral nucleoside analog cause that tin inhibit the replication of SARS-CoV-2. During preclinical pharmacodynamic studies, VV116 exerted an antiviral effect connected the archetypal strain of the novel coronavirus and its known variants successful vitro; successful the mice model, a debased dose of VV116 reduced the microorganism titers beneath the detection limit, importantly lowered the chances of lung wounded and displayed a beardown antiviral effect. Preclinical pharmacokinetics and different probe results besides amusement that VV116 has precocious oral bioavailability. Following oral medication and absorption, VV116 is rapidly metabolized into genitor nucleoside and wide distributed passim 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 nether the "The Belt and Road Initiative"); Lingang Laboratory; Vigonvita Life Sciences Co., Ltd. (“Vigonvita”); and Junshi Biosciences. Junshi Biosciences and Vigonvita are liable for the objective improvement and industrialization of VV116 worldwide. The areas of practice is planetary speech from 5 Central Asian countries, Russia, North Africa and the Middle East.
Junshi Biosciences and Vigonvita person completed 3 Phase I studies with steadfast Chinese subjects, and 1 Phase III survey successful the patients with mild-to mean COVID-19 astatine precocious hazard to progression to terrible COVID-19 successful China (NCT05341609). Research results person been published successful Acta Pharmacologica Sinica, and NEJM respectively.
In 2021, VV116 was approved successful Uzbekistan for the attraction of patients diagnosed with mean to terrible COVID-19.
About Junshi Biosciences
Founded successful December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical institution dedicated to the discovery, development, and commercialization of innovative therapeutics. The institution has established a diversified R&D pipeline comprising implicit 50 cause candidates, with 5 therapeutic absorption areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the archetypal Chinese pharmaceutical institution that obtained selling support for anti-PD-1 monoclonal antibody successful China. Its first-in-human anti-BTLA monoclonal antibody for the attraction of assorted cancers was the archetypal successful the satellite to beryllium approved for objective trials by the FDA and NMPA and has since entered Phase Ib/II trials successful some China and the US. Its anti-PCSK9 monoclonal antibody was the archetypal in China to beryllium approved for objective trials by the NMPA.
In the look of the pandemic, Junshi Biosciences’ effect was beardown and immediate, joining forces with Chinese and planetary technological probe institutions and enterprises to make an arsenal of cause candidates to combat COVID-19, taking the inaugural to enarthrosis the societal work of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. Among the galore cause candidates is JS016 (etesevimab), China’s archetypal neutralizing afloat quality monoclonal antibody against SARS-CoV-2 and the effect 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) successful implicit 15 countries and regions worldwide. As of December 3 2021, implicit 700,000 patients person been treated with bamlanivimab oregon bamlanivimab and etesevimab, perchance preventing much than 35,000 hospitalizations and astatine slightest 14,000 deaths. Meanwhile, VV116, a caller oral nucleoside analog anti-SARS-CoV-2 cause designed to hinder microorganism replication, is successful planetary Phase III objective trials. The JS016 and VV116 programs are a portion of the company’s continuous innovation for illness power and prevention of the planetary pandemic.
Junshi Biosciences has much than 3,100 employees successful the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc). For much information, delight visit: http://junshipharma.com.
Junshi Biosciences Contact Information
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+ 86 021-6105 8800
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1 Qian, Hj., et al. Acta Pharmacol Sin (2022).
2 Shen Y, et al. Emerg Microbes Infect 2022;11:1518-23.
3 The 7 hospitals participating successful the survey were: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Renji Hospital, Shanghai Jiao Tong University School of Medicine; Pudong Hospital, Fudan University; Shanghai Public Health Clinical Centre; Shuguang Hospital, Shanghai University of Traditional Chinese Medicine; Huashan Hospital, Fudan University; and Tong Ren Hospital, Shanghai Jiao Tong University School of Medicine.
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