In front of Yang Rui is 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, Fan Yuanwei, Song Hongxi, and Yang Rui.

Fan Yuanwei and Song Hongxi, Yang Rui has seen them, but they are not familiar with them, and they can't even remember whether they are a university system or a research system, but these are not important.

Applications for new drugs to join the WTO are not uncommon, China is not the United States, in the United States FDA, any new drug is approved, or even any generic drug is approved, will bring about a chain rise in the stocks of pharmaceutical companies, and any signing will mean a value of hundreds of millions of dollars. The US FDA passes about 40 new drugs every year, several times as many generic drugs, and each time it will bring attention from the media and the industry.

However, China is a latecomer country, there are countless kinds of very mature drugs used abroad, waiting for the Chinese government to approve, plus generic drugs, as well as Chinese patent medicines, China's most annual approval, two or three thousand drugs into the market, except that relevant companies will be interested, others do not care what the average 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 drug name on the application form: tambocor.

Jingxi Pharmaceutical General 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, and finally determined that this tambocor was the tambocor.

A lethal drug that could kill tens of thousands of people!

Compared to the famous drug incidents in history, such as the poison capsule incident in China, Tampocor can be said to be almost unknown. However, there is no one in the industry who does not know about this drug.

Because the number of deaths in the law is perhaps the highest in the world.

This is a drug used to treat premature cardiac beats.

From a 21st-century point of view, premature cardiac contractions do not require treatment, and ordinary people can experience premature cardiac beats, as long as more serious problems do not occur, premature cardiac beats do not need to be a concern.

However, this 21st-century view was derived from the lives of tens of thousands of people through drugs like tambocor.

In the 70's, especially in the 80's, the idea of treating premature cardiac beats was very popular.

In fact, in this golden age of science, even the average person has a sense that we can do anything – perhaps only the average person thinks so, and doctors and pharmaceutical companies use this idea to try to treat every disease they can think of.

Premature cardiac beats are 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 a long-term medication.

However, the ideas of ordinary people are always influenced by the academic community, there may be delays, there may be distortions, and there may be changes, but when the academic community really has a consensus, there are few ordinary people who are 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.

As early as the 70s, the medical community came up with a theory that made pharmaceutical companies ecstatic: premature ventricular contractions could somehow lead to fatal fibrillation and cardiac arrest, which in turn led to sudden death.

Despite the "maybe" and "some" definitions, the medical community's theory of premature cardiac beats is still in line with the expectations of pharmaceutical companies - the idea that premature beats may be fatal is not obvious.

Since premature beats can be fatal, it is natural to develop a drug that inhibits premature beats in order to avoid death, or at least to reduce the proportion of deaths.

This was the case with tamboocor and became the highly anticipated star drug of the 80s.

Pharmaceutical companies hyped it, and doctors prescribed millions of copies.

The patient's choice is very small.

Being able to stand out from an average of thirty or forty new drugs per year, and three or four hundred new drugs in ten years, tambocor naturally has its value.

Its main value is that: first, premature cardiac contractions are a common disease (phenomenon), and second, suppressing premature cardiac contractions requires long-term medication.

The first point means a large audience.

The second point is that it means taking medication for a long time.

A drug that treats a disease is actually of no value to pharmaceutical companies and investors, just like an antibiotic. Why are there no pharmaceutical companies that continue to develop antibiotics? Why are pharmaceutical companies still pretending to be invisible 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 the antibiotics used to treat superbugs are super expensive, such as tens of thousands of dollars, or even hundreds of thousands of dollars, they still can't make a payback for pharmaceutical companies, let alone profits.

The number of superbug patients is extremely small, which is contrary to the first point, there are only a few cases of superbugs per year in the world, and the maximum number of superbug patients is only a few dozen, which is not enough for pharmaceutical companies to even conduct testing.

And not being able to take drugs for a long time is the most disgusting thing for pharmaceutical companies.

If you can't take medicine for a long time, it means that the profit is unstable, and there is no stable profit, so why spend ten years and hundreds of millions of dollars to research a drug?

Serious 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, and their number, although quite large, is not a lot, and most importantly, they often die, so that you have to constantly develop new customers.

It is easy to suppress the premature heart beat.

There are millions of premature heart beats in the United States, and if the census were conducted, there could be tens of millions.

Globally, at least 10 times as many patients in the United States.

When you think about it, it's comparable to the scale of diabetes.

The $10 billion market seems to be beckoning to pharmaceutical companies.

How can tambocor not become a star drug?

Yang Rui's application for a new drug to enter the market is evidence of tambocor as a star.

The company behind Tambocor is clearly trying to promote Tambocor on a global scale.

Although China's pharmaceutical consumption power is completely incomparable to that of the U.S. market, as a long-term drug, 3M is clearly not prepared to abandon the Chinese market.

Yang Rui picked up the application and read it carefully.

And his brows furrowed quietly.

BWI Pharmaceutical is still very well prepared, at least for pharmaceutical agencies, and their applications are fully in line 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, a truckload of Chinese patent medicines can be loaded just by applying for them every year in China, and tambocor has at least done animal toxicity tests, and the clinical double-blind experiments are slightly problematic, but they have also been done.

To be reasonable, in terms of the application made by Jingxi Pharmaceutical General Factory, Yang Rui's signature is the most compliant approach.

Submitting an application to the Ministry of Health for this drug that has already been marketed overseas is basically a formality.

The Ministry of Health forwarded the application to the GMP Committee, and the Office of the Standing Committee of the Committee assigned the application to a three-member review team.

It's just that Yang Rui can't go through this transition.

Yang Rui couldn't help but sigh heavily.

"Now, the pressure is great. Yang Rui thought in his heart, but he had already made a decision that he must not approve Tampocor's application.

Although Chinese are not as rich as Americans, and there will be millions of people who have premature heart beat problems that do not affect their lives, with the size of China's population, even tens of thousands of people taking medicine, it may also kill hundreds of people, affecting hundreds or even more patients and their families.

Over time, or something happens, it is not impossible for the number of people taking medicine to increase to 100,000, hundreds of thousands, to the point that tens of thousands of people will be affected.

If it had nothing to do with Yang Rui, he wouldn't have gone out of his way to do charity – 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 just hit Yang Rui's hands.

Yang Rui read the application in his hand three times, and after confirming that he had not missed it, he carefully locked it in the drawer.

Then he stood up, took two deep breaths, then opened the door and strode to the office of the Standing Committee of the GMP Committee.

……

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