On the evening of April 17th, Junshi Bio released the latest research results of COVID-19 oral drug VV116: in the mouse model, the antiviral effect is significantly better than that of ribavirin, and can alleviate the pathological damage of lung tissue.

The research and development of domestic COVID-19 small molecular drugs has ushered in a critical time. Not long ago, the development pharmaceutical industry also announced the results of phase III clinical trials of procuramide, and the real biological Azvudine also updated the relevant progress at the Drug Review Center.

The first domestic oral drug COVID-19 is about to appear, or will be born in the above three drugs.

Phase III clinical study in progress

VV116 is a new oral nucleoside anti-SARS-CoV-2 drug, which can inhibit the replication of novel coronavirus.

Preclinical studies showed that VV116 showed significant anti-novel coronavirus effect in vivo and in vitro, showed antiviral activity against novel coronavirus original strain and known important mutants (Alpha, Beta, Delta and Omicron), and had high oral bioavailability and good chemical stability.

The drug is jointly developed by Shanghai Institute of Medicine, Chinese Academy of Sciences, Wuhan Institute of virus, Chinese Academy of Sciences, Xinjiang Institute of Physicochemical Technology, Chinese Academy of Sciences, Central Asia Drug Research and Development Center of Chinese Academy of Sciences / Wangshan Wangshui and Junshi Biology.

In September last year, Juntuo Biology, a subsidiary of Junshi Biological Holdings, signed a cooperative development contract with Wangshan Wangshui to jointly undertake the clinical development and industrialization of VV116 in the cooperative area. The cooperation area is on a global scale except the five Central Asian countries, Russia, North Africa and the Middle East.

Junshi Bio said that the preclinical in vivo efficacy of the drug as a potential respiratory syncytial virus (RSV) inhibitor was published online in the Nature publication signal Transduction and targeted Therapy.

According to its introduction, in the mouse model, VV116 has high oral bioavailability, good tissue distribution and significantly better antiviral effect than ribavirin, 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 Uzbekistan among moderate and severe COVID-19 subjects. The results showed that compared with the control group, VV116 group could better improve the clinical symptoms of patients, 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 for the treatment of moderate to severe COVID-19 patients in Uzbekistan. At present, VV116 is in the phase of international multicenter III clinical research, and a number of clinical studies are under way for patients with mild to moderate and moderate to severe COVID-19.

The first domestic oral drug COVID-19 is about to be born.

Domestic COVID-19 oral drug research is ushering in a critical period, and recently a number of companies have announced their research progress.

On April 6th, Hong Kong listed company Development Pharmaceutical released the key data of the third phase of the global multicenter clinical trial of procuramide in the treatment of non-hospitalized COVID-19 patients with mild to moderate illness. the share price nearly tripled in one day.

Studies have shown that proclomide can effectively reduce the hospitalization / mortality of COVID-19 patients with mild to moderate illness, especially for all patients who take medication for more than 7 days, the corresponding protection rate is up to 100%. In subjects with high risk factors (especially in the middle and high age group), it can significantly reduce hospitalization / mortality, significantly and continuously reduce the load of novel coronavirus, and improve COVID-19-related symptoms.

On April 2, the website of the Drug Review Center showed that real creatures had submitted applications for III communication meetings, and the status bar had been changed from "in processing" to "feedback". The market interprets this as Azvudine Phase III clinical blindness and listing declaration is imminent.

It is also affected by this, China Resources Shuanghe, Aoxiang Pharmaceutical and other Azvudine concept stocks continued to soar.

According to the current progress, the research progress of the three drugs, namely, the VV116 of Junshi Biological, the procuramide of the pharmaceutical industry, and the real biological Azvudine, is the fastest, from which the first domestic oral drug COVID-19 may be born.

The clinical trial subjects of these three drugs all involve mild and moderate COVID-19 patients, of which Proctor's clinical trial of mild to moderate disease has been completed. The other two drugs have entered the phase 3 clinical phase, and industry insiders expect them to complete clinical trials within the second quarter of this year.

As for the clinical trial of moderate and severe COVID-19 patients, the progress of azivudine is even faster, and the third phase of clinical trial has been completed. Industry insiders expect that the phase III clinical trial of VV116 may also be completed within the second quarter. The subjects of procuramide were mainly hospitalized patients.

From this point of view, the clinical research of procuramide has made rapid progress, but industry insiders believe that its total sample size is small, and the P value of all the data has not been published, and further proof data may be needed.