I collect gold fingers in the heavens

Countless patients and their families, as well as various related personnel, are calling for one thing - to expand the scope and number of trials of [Redikimab], and to make it available on the market as soon as possible.

In fact, due to the particularity of drugs, the process of launching new drugs has been very long.

Ordinary drugs are nothing.

But for life-saving drugs like anti-cancer drugs, the research and development cycle of more than ten years is really too long.

Again.

People are going to die, so why worry about side effects?
As long as the medicine works.

In fact, many people have noticed this problem.

Therefore, since the new director of the FDA came to power, he has been working hard to promote the accelerated drug approval process, such as the promulgation of "Breakthrough Therapy", which reduces the review time of the new drug certification process to three months, which can shorten the time by nearly one-third.

In terms of new cancer drugs, the FDA has also promulgated a new policy for the approval of major innovative new cancer drugs - [real-time review system].

This policy can advance the marketing approval of new tumor drugs to the clinical stage, and they can be directly marketed after completing clinical trials without queuing for approval.

[Real-time review system] is to make a shared application form based on new tumor drugs provided by pharmaceutical companies, allowing FDA reviewers to add comments to these background documents to ensure timely communication and sharing of information.

Before submitting the application form and being approved, the FDA needs to review the clinical trial data in advance and in real time.

The first is to check whether the data provided by the pharmaceutical company is complete.

The second is to break the previous standard review process and help pharmaceutical companies solve the quality problems of experimental drugs.

That is to say, the original practice of conducting clinical trials before the approval of new drug applications has been changed to conducting clinical trials while conducting new drug approvals.

The direct benefit of this is that the approval of new cancer drugs will be accelerated for at least half a year, benefiting all new cancer drugs.

However, a new drug has to go through 2-3 years of research and development period, 2-4 years of preclinical trial period, plus more than one month of clinical trial approval, and then it takes 3-7 years In the clinical trial period, the approval of new drugs for marketing is about half a year, and the total time will take more than ten years.

This is foreign.

Although China is also gradually carrying out the reform of new drug research and development review, it will not be effective in a short period of time.

Moreover, even if it works, increasing the R&D speed for half a year is just a seemingly illusory concept for cancer patients who really need it.

Whether it is more than ten years or ten years, cancer patients can't wait.

But this does not mean that [Redikumab] cannot be launched on a large scale in a short period of time.

Because of the "Technical Guidelines for Conditional Approval of Drugs for Marketing (Trial)" document issued before.

According to the principle of the guidance document, during the clinical trial of drugs, drugs that meet two specific conditions can apply for conditional approval.

The first is to treat diseases that are seriously life-threatening and for which there is no effective treatment, and drugs that are urgently needed in public health, and the data of drug clinical trials have shown curative effect and can predict its clinical value;

The second is vaccines that are urgently needed to deal with major public health emergencies or other vaccines that are determined to be urgently needed by the National Health Commission, and the benefits are assessed to outweigh the risks.

This guiding principle applies to traditional Chinese medicines, chemical drugs and biological products that are not marketed in China.Of course, there are also technical requirements for marketing approval and conditions for effectiveness evaluation.

The [Redikumumab] produced by [Xuanhu Technology] obviously meets the standards of this guiding principle.

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The voices on the Internet and in reality are too loud.

It is impossible for officials to ignore.

On the one hand, they organized professionals to conduct a comprehensive verification and evaluation of [Redikumab].

The other side is to contact [Superior Group].

Yes.

Skip [Xuanhu Technology] directly.

Communicate with real leaders.

"Wu Dong, if [Redikumab] enters the clinical monitoring period directly, will [Chaoqun Group] handle it?"

"No problem!" Wu Siyuan replied without any hesitation.

"How much does [Chaoqu Group] charge for this drug?" the leader asked.

Wu Siyuan said, "Even if it's on the market, it's only in the clinical testing period, and it's still in the clinical trial stage. Since it's in the clinical trial stage, [Redirimumab] will only charge basic service fees, and the price of the drug will still be free."

"Only [Redikimab] fully proves its effect, will the issue of charging be considered."

"The cost of [Redirimumab] is not low. In terms of fees, [Xuanhu Technology] will make comprehensive considerations to ensure that every patient can receive medical treatment when needed without affecting the company's sustainable development. , take this anticancer drug, and live with dignity..."

Wu Siyuan's words stunned the leaders above.

When a normal pharmaceutical company encounters this situation, it considers how to generate income.

But [Xuanhu Technology] is still free.

You know, there are more than 450 million cancer patients in the country every year.

As long as the curative effect of [Redikumab] is affirmed, it will be sought after by countless patients.

In Wu Siyuan's words, it is tantamount to freeing the 450 million cancer patients of [Redikumumab].

With the current efficacy of [Redikumumab], even if [Xuanhu Technology] is priced at [-] yuan, there will be a lot of cancer patients rushing to pay for it.

450 million cancer patients, that is 500 billion income.

The price of [-] is actually quite conservative.

Like those international pharmaceutical companies, if [Redikumab] is developed by them, the price may be hundreds of thousands or millions.

Like the miracle drug [Greet] used to treat leukemia, the price is high, and many leukemia patients have sold their houses in order to survive.

It is conceivable how exaggerated the loss of [Super Group] would be, as high as hundreds of billions.

Although the above leaders know that free may be the initial stage, [Redikimab] will definitely charge in the later stage.

But Wu Siyuan's decision made the leaders above feel mixed feelings.

On the one hand, they feel gratified that there are such enterprises in China.

But on the one hand, they are worried about the existence of such enterprises in the country.

[Superior Group] has developed too well and is too powerful.

The industries it entered have basically achieved the leading position.

Like the previously inconspicuous medical business in the series of [Super Group], after the product [Redikumumab] comes out, it is bound to bring [Xuanhu Technology] to become Pfizer in China.

Coupled with the wireless charging technology mastered by [Super Group], artificial intelligence technology, super-accurate weather forecasting technology, etc.

[Superior Group] not only scares foreign competitors.

It also made some people in the country feel more and more restless.

And this point, Wu Siyuan has already clearly felt it.