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On the evening of December 21, Xiao Lin, who was in Beijing, heard that Jingdong Internet Hospital could open Pfizer's Paxlovid (nemateverr / ritonavir tablets) for 2,980 yuan
.
However, when she entered the relevant page, she found that the drug was temporarily out of stock - and the people who heard the news had snapped it up
.
In the past week or two, this new crown oral medicine, which was unknown not long ago, has become the object
of many people's rush to buy not only in Beijing, Shanghai, Guangzhou and Shenzhen, but also in many second- and third-tier cities.
Paxlovid is one of the two commonly used anti-new coronavirus small molecule drugs internationally, which works to inhibit the replication of the new coronavirus, thereby reducing the risk of
hospitalization and death.
Currently, it is also the COVID-19 issued by the WHO
Treatment guidelines, the only recommended first-line use for mild to moderate patients
.
As early as March 2022, it was included in the "Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia (Trial Version 9)
".
In the past two days, Xiao Lin heard the good news
of being "late".
In Beijing, eligible people infected with the new coronavirus will hopefully open to Paxlovid
at community health service centers.
However, at present, the number of this drug in China is still very limited, and the prescribing conditions in hospitals are also extremely strict
.
Under the demand for the number of existing drugs that are difficult to meet, Indian generic drugs have entered the online shopping market
.
.
At the same time, another international mainstream anti-new coronavirus small molecule drug, Merck's Molnupiravir (Monupivir), the original drug has not yet been approved, and people have already purchased generic drugs
from Laos.
Behind Paxlovid's popularity is the increase in the number of severe patients with new crown disease in China, and the huge demand
for new crown infected people with high-risk factors to reduce the probability of severe disease.
Is this medicine really the legendary "miracle medicine"? How can it be used to reduce severe disease and mortality? Azvudine, another approved oral drug for the new crown in China, is now often used as its "replacement", what new problems may this bring? Other than that, may we have other options?
-01-
-01-Crazy snapping
Crazy snappingXiao Lin's circle of friends in Beijing mainly talks about trivial matters such as school district housing and how to spend holidays every day
.
Recently, "where to prescribe new crown drugs" has become an increasingly frequent topic
.
Not long ago, Beijing United Family Hospital announced that it can provide Paxlovid to people infected with tumors, limited to 30 boxes per day, 2380 yuan per box plus 1200 yuan for diagnosis and treatment
.
A friend immediately uploaded the medical records of the elders in the family, and after consultation with the doctor, made an appointment to pick up the medicine
.
As in Jingdong Internet Hospital, eligible infected people need to be quick to be able to prescribe medicine
.
United Family was also quick to say it was out of stock
.
The same scene
has been playing out in Shanghai and Guangzhou United Family Hospitals and Jiahui International Hospital in Shanghai for several days.
On social media, "new crown oral medicine" and "new crown specific medicine" have also become more and more hot topics
recently.
Many people asked on Weibo where to prescribe this medicine, and some people urgently "urgently"
for their elders who have been infected with the new crown and are in a bad situation.
In first-tier cities, the drug has recently even been compared to Moutai, "suitable for gifting", some people say
.
And a bank employee said that one of their big customers' new way to "show off their wealth" was to post the Paxlovid
they had just bought in the circle of friends.
that you just bought in the circle of friends.
On the evening of December 22, Xiao Lin finally "grabbed" a box of Paxlovid
on the "Ark Cloud Doctor" platform after consultation with an Internet hospital doctor on the "Ark Cloud Doctor" platform.
After receiving the goods, she immediately sent it to the elder in her hometown - the elder had a basic disease, and after three days of "yang", he still had a high fever, coughed badly, could not sleep all night long, and had some mental breakdowns
.
When Xiaolin placed an order, the price of a box was 2950 yuan
.
A few days later, a friend who bought it through the same channel said that the price had risen to 3,500 yuan
.
And the rising prices did not deter people
who asked for it.
The drug buying mutual aid group she belongs to is constantly joined by new people, describing the emergency situation since her parents were infected with the new crown, asking where else to buy it
.
However, later people became more and more disappointed
.
They exchanged news with each other: "Ark Cloud Doctor" is out of stock, and Jingdong Internet Hospital has been out of stock for most of the time recently, which third-class hospital may be able to open
.
Paxlovid is hard to come by
.
Many people who can't grab it will buy a box of azvudine as a "flat replacement" (affordable alternative).
This domestic new crown oral medicine is relatively easy to obtain
on the online platform.
.
Many people who can't grab it will buy a box of azvudine as a "flat replacement" (affordable alternative).
On December 17, Li Jun in Beijing received 5 boxes of azvudine purchased online, a total of 1,645 yuan
.
He originally wanted to buy Paxlovid, but even asked for international students in the UK, but still could not buy it
.
Experts have been worried about the online sale of such drugs
.
Many rush buyers have far exceeded their actual expectations for the effects of such drugs, and lack sufficient understanding
of the rules of use.
of the rules of use.
Xiaolin, who is still in the mutual aid to buy medicine and use medicine, is also worried
about the increasing number of drug seekers.
"As soon as someone entered the group, they asked, how many boxes of this medicine is good? Apparently ignorant of
medication.
She said
.
-02-
-02-Excessive expectations, great risks
Excessive expectations, great risksIn fact, even Paxlovid is far from being called a "new crown drug"
.
.
How effective is this drug? The most suitable reference is real-world research data
.
Recently, the Lancet, a leading international medical journal, published the results of a study
from the University of Hong Kong.
The research team analyzed the health records
of about 1.
075 million people infected in Hong Kong from February to June 2022.
Of these, 6,464 took Paxlovid
.
They found that patients taking Paxlovid had a 66 percent lower risk of death, a 24 percent lower risk of hospitalization, a 43 percent lower risk of disease progression after hospitalization, and a 75 percent
lower risk of in-hospital death, relative to the control group.
However, there was no clear difference
in ventilator use between the two groups.
in ventilator use between the two groups.
Another international mainstream new crown oral drug, Merck's Molnupiravir, was also in this study, with 5383 people taking the drug
.
Compared to the control group, patients taking monupivir had a 24% lower risk of death, no significant reduction in the risk of hospitalization, a 43% lower risk of disease progression after hospitalization, and a 47%
lower risk of in-hospital death.
A paper published in the New England Journal of Medicine in September by a team of researchers from Tel Aviv University in Israel showed that Paxlovid reduced the risk of hospitalization by 73 percent and the risk of death by 79 percent for people aged 65 and older, but did not significantly help
younger people.
for younger groups.
Obviously, human beings still know too little about the new crown virus, and "special medicine" and "miracle medicine" do not currently exist
.
Many experts believe that it is inappropriate
to give the right to prescribe new crown oral drugs to the Internet.
Currently, both Paxlovid and Azvudine can be purchased
this way.
"If the door opens too wide, something will go wrong
.
" Virologist Chang Rongshan said
.
Paxlovid's instructions have a thick stack, detailing that the drug is prohibited from being used in combination with ten major classes of drugs, and taking it at the same time as more than thirty classes of drugs will cause drug interactions, and the dosage needs to be adjusted and paid close attention
.
This drug is not only not suitable for infected people to take on their own, but also has relatively high
requirements for prescribing doctors.
Taiwan recently announced a case: a new crown infected person went to the emergency department
due to drug interaction side effects after taking the drug.
The director of the pharmacy department of a large local hospital reminded that doctors must understand the patient's physical condition and all the drugs he is using in great detail, and prescribe it after comprehensive consideration to avoid regrets
.
requirements for prescribing doctors.
The doctor must understand the patient's physical condition and all the drugs he is using in great detail, and prescribe it after comprehensive consideration to avoid regrets
.
-03-
-03-Hospitals can be opened, but the need is still far from being met
Hospitals can be opened, but the need is still far from being metAccording to media reports, in Beijing, multiple boxes of Paxlovid are being delivered to a number of community health service centers, where trained community doctors will prescribe them, instruct eligible infected people in their jurisdictions to take them, and be included in medical insurance reimbursement
.
It is administered in the clinic and under the guidance of a doctor, which is exactly how this drug is routinely used in many mainstream countries
.
This is because this medicine needs to be taken within 5 days of infection, and the sooner you start taking it, the better
the results.
.
Such a time limit for medication is related to the course of the disease after the human body is infected with the new crown virus: a few days before infection, the virus replicates
in large quantities.
After that, the virus may invade the organs, and in the process the human body may have an "immune storm", resulting in serious damage
to the body.
Therefore, the treatment methods in the days before the new crown infection are mainly antiviral; In the middle and later stages of infection, it is mainly immune regulation - even if the virus is completely killed, it is difficult to prevent the continued development
of the disease.
Therefore, anti-new coronavirus small molecule drugs such as Paxlovid are required to be taken
in the early stages of infection.
of the disease.
At present, only the Beijing area has announced the availability of this drug
in community hospitals.
However, this may indicate that this approach will be carried out
in more regions in the future.
On December 20, at a press conference held by the joint prevention and control mechanism of the State Council, Wang Guiqiang, director of the Department of Infectious Diseases of Peking University First Hospital, introduced the use of Paxlovid and said that antiviral drugs will gradually be provided at the medical institution and community level, and infected people, especially those at high risk of severe disease, are requested to use
reasonably under the guidance of doctors.
The Notice on Printing and Distributing the Overall Plan for the Implementation of "Class B and B Management" for Novel Coronavirus Infection issued by the National Health Commission on December 26 specifically mentions such drugs
.
"Medical institutions at or above the county level dynamically prepare traditional Chinese medicines, anti-new coronavirus small molecule drugs, antipyretic and cough treatment drugs and other symptomatic treatment drugs
according to the daily usage of three months.
"
However, many sources show that the number of this drug in China is still very limited
.
Therefore, the prescribing conditions of hospitals are also more stringent
.
.
Therefore, the prescribing conditions of hospitals are also more stringent
.
A doctor at a tertiary hospital said that some drugs have recently arrived, and the tentative prescription is based on patients
over 65 years old with underlying diseases, or diagnosed with severe disease.
In many hospitals, Paxlovid is prescribed to many critically ill patients
.
This is not the most suitable way to use this drug, but anxious patients' families often regard it as a "life-saving drug" and strongly demand it
.
On December 28, a number of community hospitals in Beijing said: There is no such drug yet, I don't know when it will be available, and I don't know what standards can be prescribed, and I won't know
until the drug arrives and the hospital has a meeting.
According to the "21st Century Business Herald", the prescribed standards disclosed by a community hospital are: first of all, if you are infected over 70 years old, you must also meet one of the following conditions: continuous high fever (body temperature exceeding 38.
5 degrees Celsius) for more than three days; blood oxygen saturation is less than 90%; Situations
such as holding your breath.
Staff at a community hospital revealed that the number of drugs to arrive will be very limited, perhaps only 30
.
Obviously, according to the radiation range of a community hospital, the number of elderly people with underlying diseases and high risk of severe disease in the jurisdiction far exceeds this number
.
.
The need is far from being met
.
On the Internet, a large number of people still buy a box of Paxlovid
every day for elders who have serious disease risk factors at home.
There are "scalpers" who offer prices of 15,000 or even 50,000 a box
.
-04-
-04-Azvudine is fully stocked, another hidden worry
Azvudine is fully stocked, another hidden worryWhile the number of Paxlovid is extremely limited, another domestic new crown oral drug Azvudine covers a larger terminal
.
A doctor at a third-class hospital in Beijing said that the supply of azvudine in the city is relatively adequate
.
In mid-December, Fosun Pharma, a strategic partner of Azvudine manufacturer Real Biologics, publicly stated that the drug has been listed on the medical insurance network in 31 provinces across the country, and is accelerating the terminal distribution of hospitals across the country, and has now covered more than 2,000 hospitals
across the country.
Recently, in hospitals in many second- and third-tier cities, azvudine has arrived, and its prices range from more than 200 to more than 300 yuan a box
.
Shandong media reported that on December 16, Azvudine was already available for reservations at Jinan Quanfu Hospital, with 500 appointments in less than an hour
.
By December 18, the head of the hospital publicly stated that the first batch of 5,000 copies had been sold out, and an additional 10,000 copies
had been urgently added.
Henan media reported that on December 17, hospitals in Zhengzhou opened the sale of azvudine, 330 yuan per bottle, which can be purchased
by prescription at fever clinics.
On December 16, a nurse at a third-tier city hospital in Sichuan saw the group notice: "The western pharmacy has the drug azvudine for the treatment of the new crown, once a day, one tablet each time, the price is 270 yuan / box, and it can be taken for 1 week
.
" However, she said, at present, no patients have prescribed the drug
in the hospital.
As for the medical staff of this hospital themselves, "all they drink are Chinese medicine"
.
Like Paxlovid, azvudine has a number of contraindications and must be used
under the guidance of a clinician.
The instructions indicate that it has not been studied in patients with liver and kidney function impairment, and it is recommended that patients with moderate and severe liver function impairment and patients with moderate and severe renal function injury should be used
with caution.
Considering its impact on the liver and kidneys, "if the symptoms of ordinary new crown patients are mild, the adverse reactions of taking this drug may exceed the new crown reactions
.
" When the risks outweigh the benefits, it is irrational drug
use.
Wang Haiyin, director of the Health Technology Evaluation and Research Department of the Shanghai Health and Health Development Research Center, said
.
Wang Haiyin also has a concern - the indications of azvudine include both new crown and AIDS
.
Poor sales regulation can lead to gaps
in HIV control.
.
Poor sales regulation can lead to gaps
in HIV control.
AIDS is a Class B infectious disease in China, and the state will strictly supervise the personal information and medication of infected people and patients, and there are also designated hospitals to treat
them.
Once the infected person and the patient are diagnosed in the general hospital, the hospital needs to report to the CDC
immediately.
In addition, according to the AIDS Prevention and Control Regulations, this group has the obligation to accept epidemiological investigation and guidance from the
CDC and other institutions, and truthfully inform the receiving doctor of their own situation when seeking medical treatment.
"People living with HIV may acquire azvudine
in the name of treating the new crown.
Here, there is a regulatory void
.
Wang Haiyin said
.
Wang Haiyin believes that for such drugs with multiple indications, the Medical Administration of the National Health Commission needs to issue some regulations to fill the regulatory gap
.
-05-
-05-It has not yet been approved, and generic drugs have entered the market
It has not yet been approved, and generic drugs have entered the marketAt present, the mainstream new crown oral drugs in the European and American markets, in addition to Pfizer's Paxlovid, there is also Merck's monupivir
.
.
However, monupivir is currently not approved
in Chinese mainland.
In June 2022, some media reported that Merck had submitted application materials
to CDE on a rolling basis.
In September, Merck announced that it would authorize Sinopharm to be responsible for the exclusive import and distribution rights of monolavir in China
.
Since then, there has been no public approval progress
for the drug.
Some people who rushed to buy Paxlovid turned to overseas generics
of the two drugs.
Monupivir has not yet been approved, but its generic version has quietly entered the daigou market - its generic Molavir, Lao Boten Elemental Pharmaceutical (Boten) has already been bought
Elemento PHARMA) production
.
.
Common Paxlovid generics come from India and there are several different manufacturers
.
A Hong Kong daigou said that the current price is equivalent to 1,800 yuan a box, and "I heard that the mainland has already speculated more than 3,000 yuan a box"
.
However, this method of circulation cannot exclude the possibility of
buying fakes.
Science blogger "DrCash" received three boxes of Indian generic drugs in the same package and the same batch, and after mass spectrometry testing, only one box of the drug contained nematevir (the most important ingredient of Paxlovid), and the other two boxes did not
.
of buying a fake cannot be ruled out.
Both Pfizer and Merck have long put their patents for coronavirus oral drugs into the drug patent pool
.
Medicines Patent (MPP) (Medicines Patent).
Pool, hereinafter referred to as MPP), is an international organization
founded in 2010 in Geneva, Switzerland.
Traditionally, generic drug companies can apply to the MPP to obtain a license to exploit patents in the patent pool to produce and supply generic drugs
to low- and middle-income countries.
.
In January 2022, MPP announced agreements with 27 companies authorizing them to manufacture generic versions of Merck Monupivir for sale to 105 low- and middle-income countries around the world
.
Among them, 5 Chinese companies: Fosun Pharma, BrightPharma, Shijiazhuang Longze Pharmaceutical and Shanghai Disano were licensed to produce both APIs and finished drugs of monupivir, while Longhua Pharmaceutical, a subsidiary of Viva Biotech, was licensed to produce APIs of monupivir
.
On March 17, MPP announced that it had signed agreements with 35 companies to manufacture generic versions of Pfizer Paxlovid for sale in 95 low- and middle-income countries
.
Among them, 5 Chinese enterprises: Disano, Huahai Pharmaceutical, Propharma and Fosun Pharma were approved to produce APIs and preparations, and Jiuzhou Pharmaceutical was approved to produce APIs
.
Neither of the two references to low- and middle-income countries includes China
.
.
In several low- and middle-income countries, these two oral drugs have been widely produced and put into clinical use
.
.
In March 2022, Chinese businessman Zeng Lin contracted the new crown
while visiting Laos.
While shopping for medicine in downtown Vientiane, he found Molavir, a generic version of monupivir, conspicuously placed in many pharmacies, such as in front of
the cash register.
"You don't need any prescription, there are no restrictions, you can buy it with money, you can buy as much
as you want.
"
However, in a country that relies heavily on international aid in many ways, the price of generic drugs still forms a threshold for purchase: when it was first launched, a box of generic drugs sold for about 300-400 yuan
.
By August and September, it may be reduced to 200-300 yuan
due to the expansion of production capacity.
The monthly income of ordinary local people is less than 1,000 yuan
.
"Locals mainly drink herbs or buy cheap Thai and Laotian cold medicines to treat the coronavirus
.
" Zeng Lin said that Molavir's main audience is still foreigners in Laos, especially Chinese, and some Chinese in Laos bring them back to China
.
Recently, when Paxlovid was hyped in China, the price of this generic drug of monupivir in Laos also rose, rising to 400-600 yuan a box
.
"It's all Chinese frying
yourself.
" Zeng Lin said
.
Obviously, neither of these two generic drugs has been approved in China, and the sale is non-compliant
.
While the Indian and Laotian versions of generic drugs are entering the market, there are also Chinese pharmaceutical companies that are studying imitation
.
Inquiries into public clinical trial registration information show that both Sino and Lepu Pharmaceuticals have registered bioequivalence (BE) trials
of self-developed products for the two main components of Paxlovid, nirmatrelvir and ritonavir.
In addition, the domestic imitation of Merck Monupivir, which has not yet been approved, is also underway
.
According to the news of "Hefei Release" on December 20, monapilavir developed by Anhui Baker Pharmaceutical is waiting for approval and marketing, and has been laid out for production
.
Previously, a number of media reported that this drug is the first domestic imitation
of monupivir.
However, if these generic drugs are to enter the production and sales, they will also face patent problems
.
(The drug buyers mentioned in this article are pseudonyms)
