The latest news from the health and health committee, Red Desieve arrived in China this afternoon. Looking forward to positive clinical results!

“Redesivir”, a drug that is not yet on the market and is still under development, has become the focus of Chinese people.

The developer of this drug is the American pharmaceutical giant Gilead Sciences, which has been listed in the TOP10 of global pharmaceutical companies for many times, along with Roche, Pfizer, Novartis, Johnson & Johnson, GlaxoSmithKline and so on.

So how did Reddiveway become the “new hope” against the new crown? Time back to January 31, the first patient with new coronary pneumonia in the United States, started to use Radixivir on the 7th day of hospitalization, fever the next day, symptoms reduced. The news was reported by the international journal New England Journal of Medicine, and more people saw the therapeutic potential of Redecive.

With new hope, Redecive crosses the ocean and begins clinical trials in China. The trial is expected to begin on February 3, enrolling 270 patients with mild to moderate neo-coronary pneumonia. In other words, in clinical trials, patients will be treated with redecive.

Redesvir is currently conducting a randomized, double-blind, controlled phase III clinical trial in China to evaluate the effectiveness and safety of the drug against the new crown. The trial was led by Professor Cao Bin of the China-Japan Friendship Hospital and lasted until April 27.

In the latest news, the National Health and Medical Commission stated that Redecive arrived in China this afternoon. We will wait and see the next clinical manifestations.

Why is Reddiveway bullish?

The first new crown patient in the United States experienced a week like this: On January 20, after a 2019-nCoV test was positive for nasopharyngeal and oropharyngeal swabs, the patient was sent to a local medical center. His symptoms included fever, cough, fatigue, vomiting and diarrhea. On the seventh night of the patient’s hospitalization, he was injected with redecive. The next day, the patient’s appetite and blood oxygen saturation improved. By January 30, all symptoms except his cough had disappeared.

Not only is the New England Journal of Medicine reporting the case of Reddivevir, on January 27, the international journal Science also published an article “Can an anti-HIV combinationor other existing drugs outwit the new coronavirus? “, Suggesting that the combination of redecide and monoclonal antibodies is likely to be the ideal therapy for new crown virus.

Gilead said: “Although there is no antiviral data showing the activity of Radixivir on 2019-nCoV (New Crown Virus), Radixivir against SARS, the virus pathogen of the Middle East Respiratory Syndrome, in vitro experiments and Animal models have shown activity. SARS and Middle East Respiratory Syndrome are also coronaviruses, and they are similar in structure to 2019-nCoV (new crown virus). “

“Redivevir is active against every coronavirus we have tested, and I would be surprised if it is not active against 2019-nCoV (new coronavirus).” Mark Densison, American coronavirus expert .

In fact, this antiviral therapy was originally developed in response to the Ebola virus, and is the result of cooperation with the US Centers for Disease Control and the Army Medical Institute. Phase III clinical trials for Ebola virus have shown a mortality rate of 53% with ridicvir and 67% without radicvir.

Because coronavirus is similar in structure to Ebola virus and both have the target of RNAi polymerase, RdRp, the drug is also likely to inhibit coronavirus.

When is it expected to “play”?

What’s the current progress of Red Seaweed? Before the outbreak of the new crown, Redecive had completed Phase I and II trials against Ebola virus in the United States, showing that its toxic and side effects are controllable.

Due to the urgency of the epidemic, through the approval and review by the ethics committee, a phase III clinical trial in China was started urgently to evaluate its effectiveness and safety in fighting the new crown.

Ridivervir has just started a randomized, double-blind, controlled phase III clinical trial, which is expected to end on April 27.

Combine all aspects of drug development. The development of new drugs is divided into four parts. First, the discovery of new drugs is mainly to select diseases and targets, find and optimize lead compounds, and the time is uncertain. The second step is pre-clinical research. At this stage, animal experiments and pharmacological studies are usually performed, which takes 3-6 years. The third step is clinical research. What this link is doing is the effect of experimental drugs on the human body, including pharmacokinetics, pharmacology, toxicology, effectiveness, etc. Stages I, II and III usually take 6-7 years. The fourth step is registration approval and post-market inspection, which usually takes six months to two years.

Arrived in the country this afternoon! Will

You can see that Redecive is in phase III clinical trials. If the phase III result is positive, Redecive should be approved by the State Drug Administration and listed.

There has not been any case where a US company’s drug under investigation was first marketed in China, but the precedents in Japan and Europe have already appeared. Redecive may be the first drug in development for a US company that is first listed domestically.

So, RhettXiwei is not on the market yet, how can it be used on patients first? This is due to the “sympathetic medication” system. When a patient’s disease is severe or life-threatening, when the existing drug does not bring effective treatment, or when the patient cannot be selected into a clinical trial for drug treatment, an application can be applied outside the clinical trial. Use unlisted test drugs.

It is interesting that this clinical trial only enrolled 270 mild and moderate patients, so how can other patients take the drug urgently? It is speculated that the “sympathetic medication” system may be a way to make more patients “medicable”. However, related policies on the sympathetic medication system are still in the country for comments.

More R & D in progress

Not only Reddivevir, but also drugs in trials such as clitoris, abidol, and more. Academician Zhong Nanshan said that at least seven small molecule drugs targeting viral RNA polymerase or protease, including CR3022 antibody drugs, are in different clinical research stages; research and development of related vaccines are also underway.

Arrived in the country this afternoon! Will

Part of the clinical trials in progress (pictures from China Clinical Trial Registry)