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国产新冠口服药VV116首次发布对奥密克戎临床研究评议,对比辉瑞效果如何?

VV116, a domestically produced oral COVID-19 drug, released a review on Omicron's clinical study for the first time. Compared to Pfizer, how effective is it?

觀察者網 ·  May 18, 2022 15:42

On May 18th, Emerging Microbes & Infections, a well-known journal in the field of infection, published a research article by the domestic team. Research data show that oral small molecule anti-novel coronavirus drug VV116, developed by Chinese scientists, can shorten the time of nucleic acid negative conversion in patients. As far as this index is concerned, compared with foreign COVID-19, such as Pfizer Paxlovid, what is the performance of domestic COVID-19 oral drug VV116? In the long run, will it have advantages in terms of price in the future?

Screenshot of the research report

Oral administration of COVID-19 at home and abroad can shorten the time of nucleic acid negative conversion.

Based on the official Wechat account "Huashan infection", the study was conducted by the National Infectious Disease Medical Center, Shanghai key Laboratory of Emergency response to Infectious Diseases and Biosafety, Professor Zhang Wenhong of Huashan infection, Professor Fan Xiaohong of Shanghai Public Health Clinical Center and Lingang Lab to evaluate the effect of VV116 on nucleic acid negative conversion time in patients with non-severe Omicron infection.

This is also the first peer-reviewed report on the results of a clinical study of Omicron infection with "domestic" anti-novel coronavirus drugs.

The research data show that:

The nucleic acid negative conversion time of the patients infected with Omicron with VV116 within 5 days of the first positive nucleic acid test was 8.56 days, which was less than 11.13 days in the control group. In symptomatic patients, VV116 administration within the time range of the first nucleic acid positive in this study (2-10 days for the first time) can shorten the nucleic acid negative time of the patients. In terms of drug safety, no serious adverse reactions were observed in patients treated with VV116.

Screenshot of the research report

On the same track, Pfizer Inc's Paxlovid (Naimatevir / ritonavir), Merck & Co Inc's Molnupiravir (Monapivir) and Gilead's Redxivir have been approved overseas. If the "length of negative time" (VV116 can be shortened by 2-3 days) is taken as the observation index, it can be found that antiviral therapy can significantly shorten the negative time of viral nucleic acid:

The clinical data of COVID-19 patient (O'Micron) antiviral treatment in Shenzhen third Hospital on April 17, cited by industry media "Xinkangjie", showed that the average nucleic acid negative conversion time of patients treated with Pfizer Inc Paxlovid was about 3 days shorter than that of the control group, and the median negative conversion time of Merck & Co Inc Molnupiravir drug intervention group was also about 2-3 days shorter than that of the control group.

According to these three sets of data alone, oral administration of COVID-19 at home and abroad may help to speed up the recovery of patients and cushion the pressure on the medical system to be run.

It should be noted that the VV116 study noted that as an open, prospective cohort study, the sample size included in this study was limited and none of the subjects developed severe or critical illness. Therefore, this study failed to collect enough data to further analyze whether VV116 has a preventive effect on the severity of Omicron infection, and only preliminarily evaluated the single index of nucleic acid negative conversion in mild patients.

More experiments and data will be needed to explain the theoretical and practical effects of VV116.

It is worth mentioning that with the progress made in the research and development of a number of oral drugs in China, in addition to VV116, oral drugs such as azivudine have shown a more obvious effect on shortening the time of nucleic acid negative conversion.

Jiang Jiandong, member of the Department of the Chinese Academy of Medical Sciences and academician of the Chinese Academy of Engineering, introduced at the China Medical Development Conference held in Beijing a few days ago that in terms of clinical efficacy, the nucleic acid turned negative after oral administration of Azvudine for 3 to 4 days, with an average medication time of 6 to 7 days, and an average of 9 days. the therapeutic effect of severe disease is similar to that of mild illness, and it is equally effective for patients who are ineffective with other drugs for many days.

Research report screenshot

Domestic COVID-19 oral medicine, will have more price advantage?

In the prevention and control of the epidemic situation, COVID-19 small molecular oral drugs are highly sought after because they are less affected by the variation of the virus strain, and have the advantages of low production cost and convenient use. The research and development process, test data and landing price of foreign Paxlovid, Molnupiravir, or domestic VV116, Azvudine and Pucruamide are the focus of attention from all walks of life.

Soochow Securities previously pointed out that VV116 started clinical trials in China in January 2022; it has been priced in Uzbekistan and is likely to disclose three-phase clinical data at the end of the month and be approved for listing in June. "with reference to the pricing of VV116 in Uzbekistan, we estimate that the domestic price per person may be between 600 and 1000 yuan."

It is reported that the price of VV116 in Uzbekistan is US $185, or about 1248 yuan.

According to the agreement of the US government, the current purchase prices of Paxlovid and molnupirvir are US $530 (RMB 3572) and US $700 (RMB 4718) per course of treatment respectively. The government purchase price of Paxlovid in many European countries is also basically between US $600 and US $700. At present, the only oral COVID-19 drug on the market in China is Pfizer Inc's Paxlovid, whose price is 2300 yuan per course of treatment, slightly lower than that in the United States and other places.

More and more domestic COVID-19 oral medicine appears, or will bring more changes to the whole track.

The translation is provided by third-party software.


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