Rebirth of the God-level Xueba
Chapter 891: Big incident
What Yang Rui faced was an application for a new drug to enter the market.
In the upper right corner of the document, the review committees are indicated, followed by Fan Yuanwei, Song Hongxi, and Yang Rui.
Yang Rui met Fan Yuanwei and Song Hongxi, but they were not familiar with them. They could not even remember whether they belonged to the university system or the research system. However, these are not important.
Applications for new drugs to enter the WTO are not uncommon. China is not the United States. In the US FDA, any new drug approved, or even any generic drug approved, will bring a chain rise in the stocks of pharmaceutical companies. Any signing means The value of hundreds of millions of dollars. The U.S. FDA approves about 40 new drugs each year, which is several times the number of generic drugs, and each time it brings the media and industry attention.
However, China is a late-developing country. There are countless kinds of mature drugs used abroad, waiting for the approval of the Chinese government, plus generic drugs for generic drugs, as well as proprietary Chinese medicines. China has approved two or three for the most one year. Thousands of drugs enter the market. Except for the interest of related companies, others don't 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 familiar and unfamiliar name of the drug in the application form.
Jingxi Pharmaceutical General Factory also marked it with the translated name: Lvboding.
Yang Rui read it three times and searched the data in his mind, and finally determined that this is the other.
A deadly drug that may kill tens of thousands of people!
Compared with the famous drug accidents in history, such as the poison capsule incident in China, it is almost unknown. However, no one in the industry is unaware of this medicine.
Because the number of deaths caused by the law is probably the highest in the world.
This is a medicine to treat premature heart beats.
From the perspective of the 21st century, premature cardiac beats do not require treatment, and ordinary people may have premature cardiac beats. As long as no more serious problems occur, premature cardiac beats do not need to be concerned.
However, this 21st-century view is derived from such drugs using the lives of tens of thousands of people.
? In the 1970s, especially the 1980s, the view of treating premature heart beats became popular.
In fact, in this golden age of science, even ordinary people have a feeling that we can do everything—perhaps only ordinary people think like this. Doctors and pharmaceutical companies use this idea to try to treat all they can. Thinking of the disease.
Premature heart beat is one of them.
Some people may say that premature heart beats are premature heart beats. Since there is no effect, why should I take medicine? And it is long-term medication.
However, the ideas of ordinary people are always influenced by the academic community, and there may be delays, distortions, and changes. However, when the academic community has truly reached a consensus, ordinary people seldom are not affected by this.
Patients are influenced by doctors, and doctors are influenced by medical experts. It is the operating law of the medical world.
As early as the 1970s, the medical community came up with a theory that made pharmaceutical companies ecstatic: premature ventricular beats may in some way lead to fatal fibrillation and cardiac arrest, leading to sudden death.
Although there are attributives such as "possible" and "something", the medical field's theory of premature heart beats still meets the expectations of pharmaceutical companies-the view that premature beats may be fatal is not obvious.
Since premature beats can be fatal, then, in order to avoid death, at least reduce the proportion of deaths, the development of a drug to suppress premature beats has become a matter of course.
It came into being and became a highly anticipated star drug in the 1980s.
Pharmaceutical companies hyped up this, and doctors wrote millions of prescriptions.
Patients have very few options.
Being able to stand out from an average of thirty or forty new drugs per year, and three to four hundred new drugs in ten years, naturally has its value.
Its main value lies in: first, premature heart beats are a common disease (phenomenon); second, to suppress premature heart beats requires long-term medication.
The first point means a large audience.
The second point means taking medicine for a long time.
A medicine to treat diseases is actually of no value to pharmaceutical companies and investors, just like antibiotics. Why are no pharmaceutical companies continuing to develop antibiotics? Why do pharmaceutical companies still pretend to be invisible in the tumultuous age of super bacteria? Because antibiotics only need to be taken for a week, at most a few weeks, to resolve the bacteria. Even if the antibiotics used to treat superbugs are super expensive, such as tens of thousands of dollars or even hundreds of thousands of dollars, it still cannot make the pharmaceutical company recover the cost, let alone the profit.
The number of patients with superbugs is extremely small, which is contrary to the first point. There are only a few cases each year in the world, and at most dozens of superbug patients, for pharmaceutical companies, even the scale of testing is not enough.
And not being able to take medicine for a long time is what pharmaceutical companies hate most.
The inability to take the medicine for a long time means that the profit is unstable and there is no stable profit. Why does it take ten years and hundreds of millions of dollars to research a drug?
Severe heart disease is actually a disease that pharmaceutical companies don't like.
Similar to antibiotics, patients with severe heart disease are usually not suitable for long-term medication. Although their numbers are quite large, they can’t be counted as many. The most important thing is that they often die so that you have to constantly develop new ones. client.
Suppressing premature heart beats makes it easier.
There are millions of people in the United States who have premature heart beats. If the census is conducted, there may be tens of millions of people.
What about the global scope? At least ten times the number of American patients.
Thinking about this number, it is almost comparable to the scale of diabetes.
The tens of billions of dollars market seems to be beckoning to pharmaceutical companies.
How can it not become a star drug?
The new drug application in front of Yang Rui is evidence of a star.
The company behind it is obviously trying to promote it globally.
Although China's pharmaceutical consumption capacity cannot be compared with the US market at all, as a long-term drug, 3M is obviously not prepared to abandon the Chinese market.
Yang Rui picked up the application form and read it carefully.
And his brows wrinkled quietly.
The preparations of Jingxi Pharmaceutical General Factory are still very sufficient. At least for the drug agency companies, their applications are in full compliance with the regulations of the state and the GMP committee.
Of course, such an application cannot be passed, such as the review by a well-known mother-in-law agency such as the US FDA, but the domestic requirements are much simpler.
After all, every year in China, only the Chinese patent medicines that have passed the application can be loaded into a truck. At least it has been tested in animal toxicity. The clinical double-blind test has some problems, but it has also been done.
To be fair, with the application form made by Jingxi Pharmaceutical General Factory, Yang Rui’s signature and approval is the most in line with regulations.
Submitting an application to the Ministry of Health for this kind of drug that has already been marketed overseas is basically a formality.
The Ministry of Health transfers the application to the GMP committee, and the committee's standing committee office allocates the application to the three-member review team, which is also a formality.
But Yang Rui couldn't go on this cutscene.
Yang Rui couldn't help sighing heavily.
"Now, the pressure will be great." Yang Rui thought in his heart~www.wuxiaspot.com~, but made a decision long ago and must not pass the application.
Although the Chinese are not as rich as the Americans, there will be millions of people suppressing the premature heartbeat problem that does not affect their lives, but with the size of the Chinese population, even if tens of thousands of people take medicines, hundreds of people may die, affecting Hundreds or more patients and their families.
As time goes by, or what happens, it is not impossible that the number of people taking medicine has increased to 100,000 or hundreds of thousands, so that tens of thousands of people will be affected.
If this matter has nothing to do with Yang Rui, he would not deliberately do charity-Yang Rui never believes that charity can change the world, he believes that science can solve bigger problems than charity, and he is also better at it.
However, this incident happened to hit Yang Rui's hands.
Yang Rui read the application form in his hand over and over again and again, and after confirming that he hadn't missed it, he carefully locked it in the drawer.
After that, he stood up, took two deep breaths, then opened the door and strode to the office of the GMP committee standing committee.
...
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