I'm collecting golden fingers from all over the world

Countless patients and their families, as well as various related personnel, are calling for one thing - to expand the scope and number of people involved in the trial of ledizumab and make it available as soon as possible.

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

Ordinary medicines are nothing.

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

Again.

People are going to die, so why worry about the side effects?

As long as the medicine works.

In fact, many people have noticed this problem.

Therefore, since the new FDA director took office, he has been working hard to speed up the drug approval process, such as promulgating Breakthrough Therapy and reducing the review time of the new drug certification process to three months, which can shorten the time by nearly one-third.

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

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

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

The FDA requires advance and real-time review of clinical trial data before an application is submitted and approved.

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

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

In other words, the original practice of conducting clinical trials first and then approving new drug applications has been changed to conducting clinical trials and approving new drugs simultaneously.

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

However, the process from R\u0026D to launch of a new drug requires 2-3 years of research and development, 2-4 years of pre-clinical testing, plus more than one month of clinical trial approval, and then takes 3-7 years. The clinical trial period and the review and approval of new drugs for sale take about half a year. The total time adds up to more than ten years.

This is foreign.

Although China is gradually carrying out new drug R\u0026D review reforms, it will not be effective in a short period of time.

Moreover, even if it is effective, increasing the research and development speed by half a year is just an illusory concept for cancer patients who really have urgent needs.

Whether it takes more than ten years or ten years, cancer patients cannot wait.

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

Because of the previously issued Technical Guiding Principles for Conditional Approval of Drugs for Marketing (Trial) document.

According to the principles of this guidance document, during drug clinical trials, drugs that meet two specific conditions can apply for conditional approval.

First, drugs that treat serious life-threatening diseases for which there is no effective treatment and urgently needed public health drugs. Drug clinical trials have data showing efficacy and can predict its clinical value;

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

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

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

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The outcry online and in real life is too great.

It is impossible for officials to ignore it.

At the same time, they organized professionals to conduct comprehensive verification and evaluation of [redizumab].

The other side is to contact [Chaoqun Group].

Yes.

Just skip [Xuanhu Technology].

Communicate with real leaders.

Dr. Wu, if [Ledimab] is allowed to directly enter the clinical monitoring period, will [Chaoqun Group] be able to cope with it?

No problem! Wu Siyuan replied without any hesitation.

What is [Chaoqun Group's] price for this drug? asked the leader above.

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

“Only when [leditimab] has fully proven its effectiveness will the issue of charging be considered.”

“The cost of [Ledimab] is not low. When it comes to charging, [Xuanhu Technology] will make comprehensive considerations to ensure that every patient can receive it when needed without affecting the company’s sustainable development. , take this anti-cancer drug and live with dignity...

Wu Siyuan's words made the leaders above stunned.

Normal pharmaceutical companies, when encountering this kind of situation, will consider how to generate revenue.

But [Xuanhu Technology] is actually free.

You know, there are now more than 4.5 million cancer patients in the country every year.

As long as the efficacy of [ledimumab] is confirmed, it will be sought after by countless patients.

Wu Siyuan's words are equivalent to giving [ledizumab] to these 4.5 million cancer patients for free.

Based on the current efficacy of [Ledimab], even if [Xuanhu Technology] is priced at 100,000, there will be a lot of cancer patients rushing to pay for it.

4.5 million cancer patients means 450 billion in revenue.

The price of 100,000 is actually very conservative.

Like those international pharmaceutical companies, if they developed [leditimab], it could cost hundreds of thousands or even millions.

For example, the previous miracle drug [Glitol] for treating leukemia was so expensive that many leukemia patients sold their houses in order to survive.

It is conceivable that [Chaoqun Group]'s losses will be exaggerated, reaching hundreds of billions.

Although the leaders above know that it may be free in the early stage, in the later stage, [redizumab] will definitely be charged.

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

On the one hand, they are pleased that there is such a company in the country.

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

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

It has basically achieved leading positions in the industries it has entered.

Like the medical business that was originally inconspicuous in the sequence of [Chaoqun Group], after the product [Ledimab] comes out, it is bound to become the Pfizer in China with [Xuanhu Technology].

In addition, [Chaoqun Group] has mastered wireless charging technology, artificial intelligence technology, super-accurate weather prediction technology, etc.

[Chaoqun Group] not only scares foreign competitors.

It also makes some people in the country increasingly sleepless and uneasy.

Wu Siyuan had already clearly felt this.

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