What exactly is China’s domestic new covid crown drug VV116?

A new crown patient was admitted to the emergency room of a hospital in Shanghai. (5 January 2023)

WASHINGTON — After the Chinese government lifted its draconian zero-clearance policy last month, the number of coronavirus cases across the country is now exploding. Long lines outside hospital emergency rooms, queues outside crematoriums, and the number of coronavirus infections that are difficult to track have all made residents in China anxious.

However, not long ago, Chinese state media reported extensively on a new Chinese-made drug, VV116, saying that it may be the latest magic weapon in the toolbox to end the new crown.

On December 29, a trial in the New England Journal of Medicine pointed out that the efficacy of a new drug developed by China, VV116, in a phase III clinical trial, can be comparable to the only new crown antiviral drug Paxlovid.

The test results showed that the Chinese drug was as effective as Pfizer’s Paxlovid in suppressing mild to moderate symptoms in high-risk people. In terms of side effects, 67 percent of the VV116 experimental group experienced side effects after taking it, compared to 77 percent for Paxlovid.

“This drug is a nucleotide designed for the replicase of SARS-CoV-2, which can interfere with the replication of the virus, reduce the amount of virus, and can be used to slow down the disease,” Professor Shi Xinru, director of the Center for Emerging Viral Infections at Chang Gung University in Taiwan, told the media.

This is the same principle as the new crown drug Paxlovid currently used in most countries around the world. These antivirals are designed to stop the virus from replicating, giving the body valuable time to build immunity to the virus. Paxlovid is currently recommended by the National Institutes of Health (NIH) for the treatment of the new crown.

According to Chinese state media reports, the VV116 study is a scientific research result completed within two months of the Shanghai lockdown in April 2022, and it is also the first Chinese self-developed new crown drug published by the authoritative New England Journal of Medicine. However, Schirth said the study is different from a true phase III clinical study.

“This study is compared to Paxlovid, which is commonly used today, which is a commonly used inhibitor of proteases. This clinical trial is a non-inferior comparison, that is, it is no worse than the Paxlovid that is currently in use,” she told the media, “This is not a real phase III clinical trial, just a comparative clinical trial.” ”

On Weibo, netizens commented on the news unevenly.

Weibo netizens’ backflip Lion King said: “I have great hopes for this new crown drug, it should be the new crown terminator, come on!”

Netizen Uwei_Yang mocked: “That is, a few years ago, I remember saying that the Sinovac vaccine was better than the Pfizer vaccine.”

Another netizen Financial Micro Perspective wrote: “Regardless of the curative effect, this pace has slowed down by a beat!”

And netizen Yin Shili spoke the hearts of many people: “No matter what, let the elderly buy medicine in the early stage of infection.”

Domestic new crown medicine

VV116 is an oral antiviral drug led by Ruijin Hospital affiliated with Shanghai Jiao Tong University and developed by pharmaceutical companies Junshi Biomedical Technology Co., Ltd. and Suzhou Wangshan Wangshui Biopharmaceutical Co., Ltd. VV116 is similar to remdesivir, developed by the US biopharmaceutical company Gilead Sciences, which has been approved to treat the new crown intravenously.

The trial, published in the New England Journal, was a single-blind trial in which researchers did not know what drugs the patients were taking, but the patients knew what drugs they were taking. About 380 people in one of the test groups took VV116, while the other control group took Paxlovid in the same amount. The course of treatment for both is five days.

The antiviral drug Paxlovid for the treatment of the new crown

The test results showed that the median time to recovery (no new crown symptoms for two consecutive days) was four days in the VV116 test group and five days for those who took Paxlovid. After four weeks, 98% of the subjects recovered and none developed severe disease.

In the trial, 26 percent of people who took Paxlovid reported changes in their sense of taste, compared with just 4 percent in the VV116 control group. People in both trial groups experienced elevated triglycerides, which may increase the risk of heart disease and stroke. However, 11% of people in the VV116 group reported this side effect, compared with 21% in the Paxlovid group.

Shanghai Junshi Biomedical Technology Co., Ltd. voluntarily disclosed the clinical research progress announcement on VV116 on January 3, which pointed out that in terms of safety, VV116 has fewer safety concerns than Paxlovid, that is, the overall side effects are lower.

Virologist Shi Xinru said that such a discovery is of great significance.

“Because Paxlovid is not available to many people, especially because it has drug-to-drug interactions. So there are people with chronic diseases, and when they take some medicine, they can’t use Paxlovid. So we need to have better medicine. VV116 has such potential, and it does have relatively few side effects,” she told the media by phone.

When will it be on the production line?

Scientists believe that VV116 needs to be tested on a larger scale to ensure its efficacy and risk of side effects. If there is an emergency, some countries may use drugs that perform well in clinical trials on patients first. VV116 has been approved in Uzbekistan for the treatment of moderate to severe COVID patients.

However, in most countries, it takes a considerable amount of time for drugs to go from clinical trials to approval by drug regulatory authorities.

Shi Xinru, a virologist at Chang Gung University in Taiwan, explained that the trial published this time is not a traditional phase III clinical trial, and even if it is a traditional phase III clinical trial, there is still some way to go before it can be approved by regulatory agencies.

She said the trial could be biased because it was not a double-blind trial and because the size of the trial group was relatively small. Therefore, the general drug regulatory agency will ask the pharmaceutical company to conduct further trials.

“Especially if the drug is to be promoted to more people, the ethnic group cannot only be Chinese, and all races may have to be tested.” When Paxlovid does clinical testing, it takes into account different races, which is relatively complete,” she said.

According to the U.S. Food and Drug Administration (FDA), phase III clinical trials typically enroll nearly 3,000 subjects. Paxlovid’s most recent clinical trial had more than 2200 subjects.

“So this drug has potential, but it is not immediately available,” explains Professor Shi.

In a statement released on January 3, Junshi Biologics also said that due to the characteristics of high-tech, high-risk, and high-added value of pharmaceutical products, the long R&D cycle of drugs, and many uncertainties, the relevant clinical research process, research results, and approval results of VV116 have certain uncertainties.

Until new drugs are approved, infectious disease scientists believe that China should go all out with the drugs it already has.

Amesh Adalja, an infectious disease physician and senior fellow at the Johns Hopkins Center for Health Security, told the media that scientists also need to study VV116’s ability to reduce hospitalization and mortality, and in the current situation, “the Chinese government can and should increase access to Paxlovid for high-risk groups to ensure adequate medical resources and minimize deaths.” ”

Professor Shi Xinru pointed out that in the current situation in China, all vaccines and drugs that can be obtained should be used quickly. “Because after all, there are some elderly people or people with chronic diseases, they are a high-risk group, and they may not be able to wait for any new drugs, so they should help these people with the resources they can get first,” she said.

“I think the fight against this global pandemic requires a global effort,” she said, adding, “Although there are some livelihood considerations between pharmaceutical companies and countries, the lives of patients must be the highest priority.” ”