Rebirth of the God-level Xueba
Chapter 891 Big Event
In front of Yang Rui was an application for a new drug to enter the market.
In the upper right corner of the document, the review committee members are indicated, in order of Fan Yuanwei, Song Hongxi, and Yang Rui.
Yang Rui had met Fan Yuanwei and Song Hongxi before, but he was not familiar with them. He couldn't even remember whether they belonged to the university system or the research system. However, these were not important.
It is not uncommon for new drugs to enter the WTO. China is not the United States. In the United States, any new drug approved by the FDA, or even any generic drug, will lead to a chain rise in the stocks of pharmaceutical companies. Any signing means worth hundreds of millions of dollars. The U.S. FDA approves about 40 new drugs every year, and generic drugs that are several times higher than this, each time attracting the attention of the media and the industry.
However, China is a late-developing country. There are countless mature drugs used abroad, waiting for the approval of the Chinese government, plus generic drugs of generic drugs, as well as Chinese patent medicines. In the most year in China, two or three drugs were approved. Thousands of drugs have entered the market. Except for the interest of related companies, other people don't care what the average seven or eight drugs approved every day are for, or whether they are really useful.
What shocked Yang Rui was the familiar yet unfamiliar drug name on the application form: .
Jingxi Pharmaceutical General Factory also marked it with a translated name: Luboding.
Yang Rui read it three times, and searched for the information in his mind, and finally decided that this is that.
A deadly drug that could kill tens of thousands of people!
Compared with those famous drug accidents in history, such as the poisoned capsule incident in China, it can be said that it is almost unknown. However, people in the industry are not ignorant of this drug.
Because the death toll of Lu Boding may be the highest in the world.
This is a drug that treats premature heart beats.
From the point of view of the 21st century, premature heart beats do not need to be treated, and ordinary people may have premature heart beats. As long as more serious problems do not occur, premature heart beats do not need to be paid attention to.
However, this view of the 21st century was obtained through the use of tens of thousands of lives through such drugs.
?In the 1970s, especially in the 1980s, the idea of treating premature heart beats became popular.
In fact, in this golden age of science, even ordinary people have a sense that we can do anything—or maybe only ordinary people think this way. Doctors and pharmaceutical companies use this idea to try to treat everything they can. thought disease.
Premature heart beats are one of them.
Some people may say, premature heart beat is premature heart beat, since it has no effect, why should I take medicine? And long-term medication.
However, the thoughts of ordinary people are always influenced by the academic world, and there may be delays, distortions, and changes. However, when the academic world truly has a consensus, ordinary people are rarely not affected by this.
Patients are influenced by doctors, and doctors are influenced by medical experts, which is the operating law of the medical world.
And back in the 1970s, the medical community came up with a theory that made pharmaceutical companies ecstatic: premature ventricular contractions might somehow lead to fatal fibrillation and cardiac arrest, leading to sudden death.
Although there are attributes such as "possible" and "certain", the theory of premature heart beats in the medical field is still in line with the expectations of pharmaceutical companies-the view that premature beats may cause death is not obvious.
Since premature beats may cause death, in order to avoid death, or at least reduce the proportion of deaths, it is only natural to develop a drug that inhibits premature beats.
So it came into being and became the highly anticipated star drug in the 1980s.
Drug companies hyped it up, and doctors wrote millions of prescriptions for it.
Patients have very little choice.
Being able to stand out from an average of 30 to 40 new drugs per year and 300 to 400 new drugs in ten years is naturally valuable.
Its main value lies in: first, premature heart beats are a common disease (phenomenon); second, long-term medication is required to inhibit premature heart beats.
The first point means a large audience.
The second point means taking medicine for a long time.
A drug to treat a disease is actually worthless to pharmaceutical companies and investors, just like antibiotics. Why are no pharmaceutical companies continuing to develop antibiotics? Why are pharmaceutical companies still pretending not to see it in the age of superbugs? Because antibiotics only need to be taken for a week, at most a few weeks, to solve the bacteria. Even if antibiotics to treat superbugs are super expensive, such as tens of thousands of dollars, or even hundreds of thousands of dollars, it still cannot make pharmaceutical companies recover their costs, let alone their profits.
The number of patients with superbugs is very small, which is exactly contrary to the first point. There are only a few cases of superbugs in the world every year, and there are no more than a few dozen cases of superbugs. For pharmaceutical companies, the scale of testing is not enough.
The inability to take medicine for a long time is the most disgusting place for pharmaceutical companies.
Not being able to take medicine for a long time means that profits are unstable and there is no stable profit. Why spend 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 there are many of them, they are not too many. Most importantly, they often die, so that you have to constantly develop new ones. client.
It is easy to suppress premature heart beats.
There are millions of people with premature heart beats in the United States, and if the census is conducted, there may be tens of millions of people.
What about globally? At least ten times the number of American patients.
Thinking about this amount, it is almost comparable to the scale of diabetes.
The market of tens of billions of dollars 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 being a star.
The company behind it is clearly trying to spread 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 give up the Chinese market.
Yang Rui picked up the application form and read it carefully.
And his brows also quietly frowned.
Jingxi Pharmaceutical General Factory is still very well prepared, at least as far as pharmaceutical agency companies are concerned, their applications fully comply with the regulations of the state and the GMP committee.
Of course, such an application cannot be passed, such as the review of 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 they have undergone animal toxicity tests. There are some problems with the clinical double-blind experiments, but they have also been done.
Reasonably speaking, taking the application form made by Jingxi Pharmaceutical General Factory, it is the most compliant way for Yang Rui to sign and approve it.
Submitting an application to the Ministry of Health for a 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 then distributes the application to a review team composed of three members, which is also a formality.
But Yang Rui couldn't go on with this cutscene.
Yang Rui couldn't help sighing heavily.
"Now, the pressure will be great." Yang Rui thought in his heart, but he had made a decision long ago, and he must not pass the application.
Although the Chinese are not as rich as the Americans, there will be millions of people who suppress premature heart beats that do not affect their lives, but with China's population size, even if tens of thousands of people take medicine, it may cause hundreds of deaths and affect people's lives. Hundreds or more patients and their families.
As time goes by, or what happens again, it is not impossible that the number of people taking medicine will increase to hundreds of thousands, hundreds of thousands, so that tens of thousands of people will be affected.
If this matter had nothing to do with Yang Rui, he would not do charity on purpose—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 matter happened to hit Yang Rui's hands.
Yang Rui read the application form in his hand three times, and after confirming that he had not missed anything, he carefully locked it in the drawer.
Then, he stood up, took two deep breaths, opened the door, and strode to the office of the standing committee member of the GMP committee.
...
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