Chapter eight hundred and ninety first major event
What Yang Rui has placed is an application for new drugs to enter the market.
The review committee members are indicated in the upper right corner of the document, namely Fan Yuanwei, Song Hongxi and Yang Rui.
Fan Yuanwei and Song Hongxi, Yang Rui, have seen each other, but are not familiar with each other, and can't even remember whether they are from university or research systems, but these are not important.
Applications for new drugs to join the WTO are not rare. China is not the United States. In the US FDA, any new drug is approved or even any generic drug is approved, which will bring a chain increase in the stocks of pharmaceutical companies. Any signing means a value of hundreds of millions of dollars. The US FDA passes about 40 new drugs every year, and each time it brings attention from the media and industry.
However, China is a latecomer country, with countless mature drugs used abroad, waiting for the Chinese government to approve it. In addition to generic drugs and Chinese patent medicines, China has approved two or three thousand drugs to enter the market in the most one year. Except for the interest of relevant companies, others do not care what the seven or eight drugs approved every day are used for, or whether they are really useful.
What shocked Yang Rui was the name of the familiar and unfamiliar drug in the application form: tambocor.
Jingxi Pharmaceutical Factory also marked it with the translation name: Lu Boding.
Yang Rui looked at it three times and searched for the information in his mind. Finally, he confirmed that this tambocor was that tambocor.
A deadly drug that could kill tens of thousands of people!
Compared with the famous drug damage incidents in history, such as the Chinese poison capsule incident, tambocor is almost unknown. However, no industry insiders do not know about this drug.
Because the number of deaths in Lu Boding may be the first in the world.
This is a drug for treating premature heartbeat.
From the perspective of the 21st century, premature heart beats do not require treatment, and ordinary people may experience premature heart beats. As long as there is no more serious problem, premature heart beats do not need to be paid attention to.
However, this 21st century view is derived from the lives of tens of thousands of people through drugs like tambocor.
?In the 1970s, especially in the 1980s, the concept of treating premature heart attacks was popular.
In fact, in this golden age of science, even ordinary people have a feeling that we can do anything - perhaps only ordinary people think so, doctors and pharmaceutical companies use this idea to try to treat all the diseases they can think of.
Premature heart attack is one of them.
Some people may say that premature heartbeat is just premature heartbeat. Since it has no effect, why should I take medicine? And it is for a long time.
However, the ideas of ordinary people are always influenced by the academic community, and may be delayed, distorted, or changed. However, when academia truly develops a consensus, few ordinary people are not affected by this.
Patients are influenced by doctors and doctors are influenced by medical experts, which is also the operating rules of the medical world.
As early as the 1970s, the medical community came up with a theory that made pharmaceutical companies ecstatic: premature ventricular dysfunction may in some way lead to fatal fibrillation and cardiac arrest, which in turn leads to sudden death.
Despite the attributions such as "possible" and "something", the medical community's theory of premature heart attack still meets the expectations of pharmaceutical companies - the view that premature attack may cause death is not obvious.
Since premature raking may cause death, in order to avoid death, at least reduce the proportion of death, it is natural to develop a drug to inhibit premature raking.
Tamboocor came into being and became the highly anticipated star drug in the 1980s.
Pharmaceutical companies are hyping this, and doctors prescribe millions of prescriptions.
There are very few choices for patients.
Tambocor is naturally valuable to be able to stand out from an average of thirty or forty new drugs every year and thirty or four hundred new drugs in ten years.
Its main value lies in: First, premature heart attack is a common disease (phenomenon); second, it requires long-term medication to inhibit premature heart attack.
The first point means a large audience.
The second point means taking medicine for a long time.
A drug that treats diseases is actually worthless to pharmaceutical companies and investors, like an antibiotic. Why no pharmaceutical companies continue to develop antibiotics? Why do pharmaceutical companies still pretend to be invisible in the era of super bacteria? Because antibiotics only need to take medicine for a week, up to several weeks to solve bacteria. Even the antibiotics that treat super bacteria are super expensive, such as tens of thousands of dollars or even hundreds of thousands of dollars, still cannot make pharmaceutical companies recover their costs, let alone profits.
The number of super bacteria patients is very small, which is just contrary to the first point. There are only a few cases in the world every year, and at most dozens of cases. For pharmaceutical companies, the scale of testing is not enough.
Not being able to take medicine for a long time is the most dislike of pharmaceutical companies.
If you cannot take medicine for a long time, it means that your profits are unstable and there is no stable profit. Why do you need to spend ten years and hundreds of millions of dollars to study a drug?
Severe heart disease is actually a disease that pharmaceutical companies do not like.
Similar to antibiotics, patients with severe heart disease are usually not suitable for long-term medication, and although there are many, they cannot be considered large. The most important thing is that they often die, so that you have to constantly develop new customers.
It will be easier to curb premature heart beats.
There are millions of people in the United States who have premature heart attacks. If a census is conducted, there may be tens of millions of people.
What about the global scale? At least ten times the number of American patients.
Thinking about this number, it can be compared to the scale of diabetes.
The 10 billion dollar market seems to be waving to pharmaceutical companies.
How can tambocor not become a star drug?
The application for new drugs in front of Yang Rui is evidence of Tambocor as a star.
The company behind tambocor is obviously trying to promote tambocor to a global scale.
Although China's pharmaceutical consumption capacity is completely incomparable to the US market, as a long-term drug, 3M is obviously not ready to give up the Chinese market.
Yang Rui picked up the application form and read it carefully.
And his brows also frowned quietly.
Jingxi Pharmaceutical Factory has prepared very well. At least for pharmaceutical agents, their application forms are fully in line with the regulations of the state and GMP committee.
Of course, such an application cannot be passed, such as the review of a well-known mother-in-law agency like the US FDA, but the domestic requirements are much simpler.
After all, every year, only Chinese patent medicines that have been applied for can be loaded with a truckload. Tambocor has at least conducted animal toxicity tests. There are a little problems with clinical double-blind experiments, but it has also been done.
To be honest, considering the application form made by Jingxi Pharmaceutical Factory, Yang Rui’s signature approval is the most in line with the regulations.
This kind of drug that has been marketed overseas, and submitting an application to the Ministry of Health is basically a formality.
The Ministry of Health transferred the application to the GMP Committee, and the Standing Committee Office assigned the application to the review team composed of three members, which was also a formality.
But Yang Rui couldn't move on to this story.
Yang Rui couldn't help but sigh heavily.
"Now, the pressure is getting too high." Yang Rui thought to himself, but he had made a decision long ago and must not pass the application of tambocor.
Although Chinese people are not as rich as Americans, there will be premature heart attack problems that are suppressed and not affected by life, with the size of China's population, even if tens of thousands of people take medicine, it may cause hundreds of people to die, affecting hundreds or even more patients and their families.
As time goes by, or if something happens, the number of people taking medicine has increased to 100,000,000, and even hundreds of thousands of people, which is not impossible.
If this matter had nothing to do with Yang Rui, he would not do charity specifically - Yang Rui never believed that charity could change the world. He believed that science could solve bigger problems than charity, and he was better at it.
However, this incident happened to Yang Rui.
Yang Rui read the application in his hand three times and confirmed that he had not missed it before carefully locking it into the drawer.
Then he stood up, took two deep breaths, then opened the door, and made great strides to the office of the Standing Committee of the GMP Committee.
Chapter completed!