On the evening of April 17, Junshi Bio released the latest research results of the new crown oral drug VV116: in mouse models, the antiviral effect is significantly better than ribavirin, and can alleviate the pathological damage of lung tissue.
The research and development of domestic new crown small molecule drugs ushered in a key point in time, and the development of the pharmaceutical industry also announced the results of the phase III clinical trial of promexime not long ago, and the real organism Azvedine also updated the relevant progress in the drug review center.
The first domestic new crown oral drug is about to be released, or will be born in the above three drugs.
Phase III clinical studies are ongoing
VV116 is a novel oral nucleoside anti-SARS-CoV-2 drug that inhibits the replication of the new crown virus.
Preclinical studies have shown that VV116 has shown significant anti-coronavirus effects both in vivo and in vitro, showing antiviral activity against both the original and known important variants of the new coronavirus (Alpha, Beta, Delta and Omicron), while having high oral bioavailability and good chemical stability.
The drug was jointly developed by the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences, the Wuhan Institute of Virology of the Chinese Academy of Sciences, the Xinjiang Institute of Physics and Chemistry Technology of the Chinese Academy of Sciences, the Central Asia Drug Research and Development Center of the Chinese Academy of Sciences/Wangshan Wangshui of the Sino-Ukrainian Medical Science and Technology City and Junshi Biology.
In September last year, Juntuo Biologics, a subsidiary of Junshi Biologics, signed 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 a global scope in addition to the five Central Asian countries, Russia, North Africa and the Middle East.
Junshi Bio said that the results of the preclinical in vivo efficacy of the drug as a potential respiratory syncytial virus (RSV) inhibitor were published online in Nature's journal Signal Transduction and Targeted Therapy.
According to its introduction, in mouse models, VV116 has high oral bioavailability, good tissue distribution and significantly better antiviral effect than ribavirin, and can alleviate pathological damage to lung tissue.
The study provides a valuable clinical drug candidate for the treatment of RSV infection. Exhibited good safety, tolerability and pharmacokinetic properties in healthy subjects.
Last year, VV116 completed a clinical trial in Uzbekistan in subjects with moderate and severe COVID-19 pneumonia. The results of the study showed that compared with the control group, the VV116 group could better improve the clinical symptoms of patients, shorten the nucleic acid negative time, 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 patients with moderate to severe COVID-19. Currently, VV116 is in the Phase III clinical study phase III of the International Multicenter, and several clinical studies are underway in patients with mild to moderate and moderate to severe COVID-19.
The first domestic new crown oral drug is about to be born
Domestic new crown oral drug research is ushering in a critical period, and recently a number of companies announced research progress.
On April 6, Hong Kong-listed company Pioneering Pharmaceutical announced the key data results of the phase 3 global multi-center clinical trial of puklamide for the treatment of mild and moderate patients with mild and medium-sized diseases, and the stock price soared nearly 2 times in one day.
Studies have shown that pkrutamine is effective in reducing hospitalization/mortality in patients with mild and moderate COVID-19, especially for all patients who have been taking the drug for more than 7 days, with a corresponding protection rate of 100%, significantly reducing hospitalization/mortality in subjects with high-risk factors (especially in the middle and upper age group), and significantly and sustainably reducing THE LOAD of COVID-19 and improving COVID-19-related symptoms.
On April 2, the website of the Drug Review Center showed that the real organism submitted a Class III communication meeting application, and the current status column has been changed from "processing" to "feedback". The market interprets this as the imminent clinical unveiling of the third phase of Azfedine and the declaration of listing.
It is also affected by this that Azvudine concept stocks such as China Resources Shuanghe and Aoxiang Pharmaceutical continue to rise sharply.
As far as the current progress is concerned, the research progress of the three drugs of Junshi Bio's VV116, the development of pharmaceutical industry proukamide, and the real bio's Azvedine has made the fastest progress, and the first domestic new crown oral drug may be born from here.
Clinical trials of these three drugs have involved mild and moderate COVID-19 patients, of which the pruk press has completed the clinical trial of mild and moderate disease. The remaining two drugs have entered phase 3 clinical phases, and industry insiders expect them to complete clinical trials within the second quarter of this year.
For clinical trials in moderately ill COVID-19 patients, azfedine has progressed faster and has now completed Phase III. Industry insiders expect that the phase III clinical trial of VV116 may also be completed within the second quarter. Prokylamine was tested primarily inpatients.
From this point of view, the clinical research of promeximide has progressed rapidly, but the industry believes that its total sample size is small, and the P value of the entire data has not been published, and further relevant proof data may be needed.
Source: Company e (ID: lianhuacaijing)
Editor: Ye Shujun
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