The first domestically produced COVID-19 oral drug has arrived in Hainan and other places! It can eliminate the virus in 5 days and was originally used to treat AIDS

Recently, the domestic oral drug Azvudine Tablets have been included in the COVID-19 diagnosis and treatment plan and have been shipped to epidemic areas such as Hainan and Xinjiang. What kind of drug is this? Is the treatment expensive? How effective is the drug? Let's take a look at the interpretation.

New Media Editor/Lv Bingxin

On August 9, the General Office of the National Health Commission and the General Office of the State Administration of Traditional Chinese Medicine issued a notice stating that Azvudine tablets will be included in the "Diagnosis and Treatment Plan for New Coronavirus Pneumonia (Ninth Edition)".

▲Screenshot of the notice from the National Health Commission’s official website.

Azvudine tablets are my country's first approved Class 1.1 small molecule oral drug for the treatment of COVID-19 with completely independent intellectual property rights and global patents.

In terms of inhibiting the novel coronavirus, Azvudine tablets can inhibit the activity of the novel coronavirus. In terms of safety, Azvudine tablets were generally well tolerated, and there was no statistical difference in the incidence of adverse events between the Azvudine tablets group and the placebo group, and the risk of the subjects was not increased.

Each bottle is less than 300 yuan, which has a great price advantage

Recently, the epidemic has spread in Hainan, Xinjiang and other places in China, and the epidemic prevention and control situation remains severe and complicated. On the evening of August 11, it was learned from Fosun Pharma that Fosun Pharma and Henan Zhenzhen Biotechnology Co., Ltd. actively responded to the needs of local governments and urgently deployed anti-new crown pneumonia small molecule oral drug Azvudine tablets to help many places across the country. Recently, it has been shipped to Hainan, Xinjiang, Henan and other places.

(Photo source: Fosun Pharma)

The price of Azvudine tablets was also revealed for the first time. Fosun Pharma said that according to the prices listed on the local medical insurance network, Azvudine tablets are priced at 270 yuan per bottle, 35 tablets per bottle, and 1 mg per tablet. Compared with the currently available new crown treatment drugs, Azvudine tablets have a greater price advantage.

According to the "New Coronavirus Pneumonia Diagnosis and Treatment Plan (9th Edition)", Azvudine tablets are used to treat common new coronavirus pneumonia (COVID-19) in adult patients. The dosage is to swallow the whole tablet on an empty stomach, 5 mg each time, once a day, and the course of treatment is no more than 14 days. According to the above dosage and dosage per tablet, the reporter calculated that the patient needs to take 5 tablets a day, and 70 tablets are needed for 14 days of treatment, which is the dosage of two boxes, and the cost is 540 yuan.

A typical "old drug with new uses", originally used to treat AIDS

Azvudine is an oral dual-target nucleoside antiviral drug and was not specifically developed for COVID-19.

On July 20, 2021, the National Medical Products Administration conditionally approved the use of azithromycin tablets in combination with other reverse transcriptase inhibitors to treat adult HIV-1 infected patients with high viral loads. In the earlier stage, azithromycin was developed as an anti-hepatitis C virus drug, which is a broad-spectrum antiviral drug. On July 25, 2022, the National Medical Products Administration conditionally approved the registration application of Real Biological Azithromycin Tablets to add the indication of new coronary pneumonia treatment, for the treatment of adult patients with common new coronavirus pneumonia.

How can drugs used to treat HIV-1 infection be used to treat COVID-19?

This involves a concept called "new uses for old drugs", which refers to drugs originally used to treat a certain disease, but can be used to treat another new disease because of the common mechanism. If we make an analogy, azithromycin and its viral target are like the relationship between a key and a lock. After the key is inserted into the lock, it can block the keyhole and destroy its function.

Different viruses sometimes have targets with similar active structures (similar to locks with similar keyhole structures), so in early papers, researchers pointed out that azithromycin may also be used to inhibit hepatitis B and hepatitis C viruses. Recently, there is evidence that it can inhibit the viral RNA-dependent RNA polymerase (RdRp) of the new coronavirus, which is the mechanism by which it can inhibit the new coronavirus.

The thymus is a key organ for immunity against COVID-19. Azvudine can be concentrated in the thymus in an active form to a large extent, effectively inhibiting the replication of the new coronavirus in the body, protecting the immune function of the thymus, and quickly curing COVID-19 patients.

In the previous application for listing submitted to the National Medical Products Administration, Real Biotech attached the results of the Phase III registration clinical trial. The press release pointed out that Azvudine can significantly improve clinical symptoms, that is, "it can significantly shorten the time for symptom improvement in patients with moderate COVID-19 infection pneumonia, increase the proportion of patients with improved clinical symptoms, and achieve clinically superior results."

In addition, Azvudine also "has the activity of inhibiting the new coronavirus, and the virus clearance time is about 5 days." In terms of safety, "Azvudine tablets are generally well tolerated" and "do not increase the risk of subjects."

Industry experts pointed out that the advantage of using old drugs in new ways is that it can reduce the risk of drug management, and the price of domestically produced drugs is relatively lower. However, since the main endpoint of the Phase III clinical trial of Azvudine for COVID-19 is to "improve clinical symptoms" rather than reduce "all-cause mortality", it is not considered a specific drug.

The number of new coronavirus treatment drugs has increased, focusing on two tracks

Neutralizing antibody drugs and small molecule drugs are the two most competitive tracks in the research and development of new coronavirus treatment drugs. Most of the drugs that have been approved for marketing or entered clinical research are also concentrated in these two areas.

"Small molecule drugs and neutralizing antibody drugs each have their own strengths and advantages." Ding Sheng, dean of the School of Pharmacy at Tsinghua University and director of the Global Health Drug Research and Development Center, introduced that neutralizing antibody drugs are a type of biological drug with good therapeutic effects and safety. Antibodies are screened from the patient's body, and the development of antibody drugs is fast, and the half-life is long. They are effective for a certain period of time after injection. Neutralizing antibody drugs designed for the new coronavirus act on a certain point of the antigen on the surface of the virus, with relatively specific targeting, and can also be used as protective drugs. The most prominent advantages of small molecule drugs are low cost, convenient oral administration, no need for cold chain storage, and are not easy to develop drug resistance due to viral mutations.

Whether it is neutralizing antibody drugs or small molecule drugs, their research and development strategies focus on attacking the virus itself. Some prevent the virus from binding to receptors, and some prevent the virus from replicating. Ding Sheng introduced that another strategy is to target the human body itself and fight the disease by regulating the human immune system. Through inhaled drugs, the immune system from the upper respiratory tract to the lungs is activated to prevent the disease from developing into a severe condition.

Oral COVID-19 drugs are an important part of controlling the COVID-19 pandemic, and they have added new members to our arsenal after vaccines and antibody drugs. With the efforts of new drug developers, we hope that we can make the epidemic less scary soon.

Dialogue with Jiang Jiandong, a participant in the development of Azvudine, academician of the Chinese Academy of Engineering, and president of the Institute of Materia Medica, Chinese Academy of Medical Sciences

Question 1: Why is the development of oral COVID-19 drugs much slower than vaccines?

Jiang Jiandong: The working principle of small molecule drugs is very different, and there are much more unknowns. The basic principle of vaccines is relatively clear, but it is not the case for small molecule drugs. If a small molecule enters the human body and is highly toxic, it will die. The research and development of many small molecule drugs is stuck in the second or third phase.

Question 2: What are the differences between domestically produced oral COVID-19 drugs and foreign drugs?

Jiang Jiandong: The difference between Azvudine and Western medicine is that Western medicine is a precise targeted treatment, while Azvudine treats both the symptoms and the root cause. In other words, it treats the new coronavirus and improves human immunity. Moreover, the dosage of this medicine is very small, 5 mg per tablet, taken orally, which is much smaller than other drugs and is very safe.

Question 3: Will the virus recur again after taking medication and recovering?

Jiang Jiandong: The situation of patients who have tested positive again after taking medication is still unclear and has not been statistically analyzed. According to clinical practice, the number of patients who have tested positive again seems to be relatively small, and further research is needed.

Question 4: Can patients who have received the new coronavirus vaccine or used antibody drugs use it?

Jiang Jiandong: Yes, it can be used. It can be used by people who have never been vaccinated, and it can be used by people with mild, moderate or severe illness.

(The content of this article is compiled from Beijing Daily, Science Popularization China, Health News, Health Times, etc.)

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