april 17, Shanghai Junshi Biosciences Co.Ltd(688180) released the latest research results of covid-19 oral drug vv116: in the mouse model, the antiviral effect is significantly better than ribavirin, and can alleviate the pathological damage of lung tissue
The research and development of domestic covid-19 small molecule drugs ushered in a key time point. The development of the pharmaceutical industry also announced the results of phase III clinical trials of prochloramide not long ago, and the real biological azvudine also updated the relevant progress in the drug examination center.
The first domestic covid-19 oral drug is imminent, or will be born in the above three drugs.
iii clinical study in progress
Vv116 is a new oral nucleoside anti sars-cov-2 drug, which can inhibit covid-19 virus replication.
Preclinical studies showed that vv116 showed significant anti covid-19 virus effect in vivo and in vitro, showed antiviral activity against covid-19 virus original strain and known important variants (alpha, beta, Delta and Omicron), and had high oral bioavailability and good chemical stability.
The drug was jointly developed by Shanghai Institute of pharmacy, Chinese Academy of Sciences, Wuhan Institute of Virology, Chinese Academy of Sciences, Xinjiang Institute of physical and chemical technology, Chinese Academy of Sciences, Central Asia drug R & D center of Chinese Academy of Sciences / Wangshan wangshui and Shanghai Junshi Biosciences Co.Ltd(688180) .
Last September, juntuo biology, a subsidiary of Shanghai Junshi Biosciences Co.Ltd(688180) holding company, 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 a global scope except five Central Asian countries, Russia, North Africa and the Middle East.
Shanghai Junshi Biosciences Co.Ltd(688180) said that the research results of 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, vv116 has high oral bioavailability, good tissue distribution and significantly better antiviral effect than ribavirin in the mouse model, and can alleviate the pathological damage of lung tissue
This study provides a valuable clinical candidate for the treatment of RSV infection. It showed good safety, tolerance and pharmacokinetic properties in healthy subjects.
last year, vv116 completed a clinical trial in subjects with moderate and severe covid-19 virus pneumonia in Uzbekistan. The results showed that compared with the control group, vv116 group could better improve the clinical symptoms, shorten the time of nucleic acid negative conversion, 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 moderate and severe covid-19 patients. 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.
first domestic covid-19 oral drug is about to be born
Domestic covid-19 oral drug research is ushering in a critical period. Recently, many companies announced the research progress.
april 6, Kaifa pharmaceutical, a Hong Kong listed company, announced the key data results of phase 3 global multicenter clinical trial of prochloramide in the treatment of mild to moderate non hospitalized covid-19 patients, and the share price soared nearly twice in one day
Studies have shown that prochloramide can effectively reduce the hospitalization / mortality of mild and moderate covid-19 patients, especially for all patients taking medicine for more than 7 days, and the corresponding protection rate is 100%; In subjects with high risk factors (especially in the middle and high age group), it can significantly reduce hospitalization / mortality; It can significantly and continuously reduce covid-19 virus load and improve covid-19 related symptoms.
On April 2, the website of the drug examination center showed that the real creature submitted an application for class III communication meeting, and the current status bar has been changed from "processing" to "feedback". The market interprets this as azvudine phase III clinical Unblinding and application for listing is imminent.
It is also affected by this that China Resources Double-Crane Pharmaceutical Co.Ltd(600062) , Zhejiang Ausun Pharmaceutical Co.Ltd(603229) and other azvudine concept stocks continued to rise sharply.
as far as the current progress is concerned, the research progress of vv116 of Shanghai Junshi Biosciences Co.Ltd(688180) and prozacamine of developing pharmaceutical industry and azvudine of real organism is the fastest, and the first domestic covid-19 oral drug may be born from it
The clinical trials of these three drugs involved mild and moderate covid-19 patients. Among them, prucker's mild and moderate clinical trials have been completed. The other two drugs have entered phase 3 clinical stage, and industry insiders expect them to complete clinical trials in the second quarter of this year.
For the clinical trial of moderate and severe covid-19 patients, azvudine has made faster progress and has completed phase III clinical trials. Industry insiders expect that the phase III clinical trial of vv116 may also be completed in the second quarter. The subjects of prochloramide were mainly hospitalized patients.
from this point of view, the clinical research of prochloramide has made rapid progress, but insiders believe that its total sample size is small, and the p value of all data has not been published, so it may be necessary to further provide relevant supporting data
