Rebirth 08: Rise from copycat phones

Chapter 350 The US FDA is in a dilemma
A high-level meeting is underway at Roche Pharmaceuticals headquarters in Switzerland.

"Affected by Galaxy Pharmaceuticals' Xiluokeda, the revenue of many of the company's products has been greatly affected."

"Rituximab for lymphoma, bevacizumab for metastatic colorectal cancer, trastuzumab for breast cancer, and pertuzumab for metastatic breast cancer, these four companies' flagship products have all been impacted to varying degrees, because Xiluokeda's indications include these three types of cancer!"

"The first three monoclonal antibody anti-cancer products were originally expected to generate revenues of between US$5 billion and US$6 billion this year, and the last one was expected to generate US$1.5 billion in revenue. Together, these four products were expected to generate US$18 billion in revenue for the company. However, we now estimate that the total revenue of these four core products will drop to around US$16 billion."

"The drug has already received emergency approval in China. This will not only cause us to lose the $400 million in revenue we originally estimated in China... Of course, this revenue would not have had a big impact, but there are quite a few customers outside of China who have come to China for treatment with the support of insurance companies, which will cause us to lose an additional $2 billion in revenue!"

"And this is not the most terrible thing. What is terrible is the future trend."

"The results of the first phase clinical trial of the drug are very good and have been recognized by many countries around the world. The drug has also started the second phase clinical trial in many countries."

"Some other countries have even begun to consider granting emergency permission to Xirokoda!"

"Even in the United States, our main market, the same is true. There is a lot of pressure from local customers, insurance companies, and even media opinions. The lobbying pressure from us and several other companies is increasing."

"Moreover, the interests of many other companies in this field are not consistent with ours. They do not have a large share in the field of anti-cancer drugs. At the same time, the indications of some of their flagship products are not yet included in the indications that Xiluokeda has announced, so it is impossible to expect them to contribute too much to this matter."

"Gentlemen, the current situation is very grim!"

In today's anti-cancer drug market, Roche can be said to be the only dominant player with four monoclonal antibody products, with huge sales... The total global anti-cancer drug market is only more than 70 billion US dollars, and Roche alone can account for a market share of about 18 billion US dollars.

However, among so many types of cancer, the 16 indications currently announced for Xiluokeda just happen to cover the indications of Roche's four monoclonal antibody products... This is very embarrassing.

How to do?
What else can they do? Of course, they use the old ways, discrediting Xiluokeda in various ways and publicizing its side effects, such as the various allergic reactions and even shock that were exposed during the first phase of clinical trials.

However, this so-called side effect is almost negligible for a life-saving drug...You are about to die, who cares about this side effect?

Therefore, it is more important to use lobbying to prevent Xiluo Keda from being listed in multiple major markets, such as Europe, Japan, and the United States. Even if it is ultimately impossible to prevent Xiluo Keda from being listed, its listing should be delayed as much as possible.

And this...is not easy.

You have to know that cancer does not discriminate against anyone. It will not favor you just because you are poor, or let you go just because you are rich... In other words, a large number of rich and powerful people will also get cancer.

At the same time, these economically well-off groups, regardless of whether they are rich or had a good financial situation before, have purchased medical insurance with very good conditions.

These groups are the main consumers of anti-cancer drugs...As for the truly poor cancer patients, no one actually pays attention to them...Patients without money are just patients, not customers!

This means that the main anti-cancer drug products of Roche and some other pharmaceutical companies are ultimately consumed by patients with good economic conditions... Even if the bills are basically paid by insurance companies, the insurance company's money also comes from its customers who purchase insurance.

And these customers, for the sake of their own lives, are now advocating and exerting pressure to get Xiluokeda listed locally as soon as possible.

In order to save money, insurance companies did not do anything too harsh, even though they had a certain tacit understanding with other pharmaceutical companies. However, they still acquiesced and even pushed this trend from behind.

Although insurance companies and pharmaceutical companies are often in the same boat... insurance companies can choose to cooperate with many pharmaceutical companies.

Galaxy Pharmaceuticals is also a high-quality partner in the eyes of many insurance companies...its Xiluokeda can save insurance companies a lot of money.

Eventually, a wave was formed in many countries, especially some developed countries. Local patients continued to put pressure on Xiluokeda to be introduced, complete clinical trials as soon as possible, and even grant emergency authorization for Xiluokeda.

Of course... those who advocate these things are generally ordinary middle-class people. The truly wealthy people often go directly to China to receive Xirokeda's treatment.

However, the voices of a large number of middle-class groups cannot be ignored.

This puts a lot of pressure on drug regulatory agencies in many countries, even a strong one like the FDA in the United States.

After all, this is not an ordinary business issue, but a matter of life and death.

A large number of cancer patients, especially those in the advanced stage, are counting on Xiluokeda to save their lives.

Although these drug regulatory agencies may make some concessions to the pharmaceutical companies in their respective countries, this is also limited. It is impossible for them to always stand up for these pharmaceutical companies!

How long they can resist depends on how much lobbying funds these pharmaceutical companies have and how long it can last... We are all ordinary people and we all have to support our families!
These realities have put Roche and many other pharmaceutical companies in a very passive position. On the one hand, revenue continues to decline, and on the other hand, the future is bleak. They also have to continue to spend money on lobbying.

How to do?
This is a big problem facing pharmaceutical companies such as Roche!
“There is no need to elaborate on the difficulties. Everyone present here knows very well that today’s meeting is not about discussing the difficulties, but about the follow-up direction!”

"How is our reverse engineering progress on Xiluokeda?"

At this time, a middle-aged bald man said: "Our reverse research progress is not ideal."

"We all know that Xiluokeda is a biomacromolecule drug based on genetic technology. It directly acts on the human immune function and allows the human immune cells to directly eliminate cancer cells. However, we still don't know how immune cells accurately identify cancer cells and how to eliminate cancer cells without stimulating a violent reaction in the human body!"

"Let alone figuring out the core principle of this drug and imitating it, even directly copying this drug and making a generic drug would be very difficult."

"You all know very well that any biological macromolecule drug is like a large aircraft, with an extremely complex structure. This is different from chemical drugs that can be simply reduced through molecular formulas!"

"Several of our flagship monoclonal antibody products belong to this category of drugs, which is one of the reasons why it is difficult for other companies to copy and imitate us... Unfortunately, Xiluokeda also belongs to this category of biological macromolecule drugs!"

"Even though they have published a lot of information including the molecular formula, it is theoretically possible to replicate it, but it is extremely difficult. We have tried to replicate it in the laboratory but have not been successful so far, let alone ensuring the purity of the drug!"

"After all, they only told us the molecular formula of the drug Xiluokeda, but did not tell us how to synthesize this molecule, let alone how to produce it and ensure its purity, as well as the drug release process, etc!"

"To be honest, we haven't made any progress in the reverse research of Xiluokeda. We haven't even figured out the basic principles of this drug yet!"

"Because this is not just an anti-cancer drug, but also a broad-spectrum anti-cancer drug. I can't imagine that immune cells can accurately identify and eliminate so many types of cancer cells. This completely goes against existing common sense!"

"At present, the results we have obtained in the laboratory can only mean that we have found a new technical route. That is, we can try to determine the treatment plan for a certain person through genetic engineering, and then synthesize customized drugs in vitro, that is, in the laboratory environment. However, this customized immune drug based on genetic technology will be extremely expensive. The cost of treating a single person may exceed one million US dollars!"

"And this Xiluokeda, its principles are also similar, but it does not need to be synthesized in vitro using a variety of laboratory equipment. Instead, it directly synthesizes a certain drug in the patient's body, and then acts on the immune function..."

"That is to say... Xiluoda itself does not actually treat diseases, and it is not even a drug that directly stimulates immune function. This drug is just a key. After entering the human body, a series of reactions will occur, and then a drug directly targeting different individuals will be produced in the body, which is then used to promote immune function!"

"In other words, they used the human body itself to replace the laboratory outside the body, and then everyone can get their own personal immune medicine."

"This is a technology route that has never appeared before, and we still don't even understand the technical principles!"

"Their research in the field of immunity is far beyond our imagination..."

In fact, a large number of Roche researchers seriously overestimated the research level of Galaxy Pharmaceuticals.

Because not only Roche researchers couldn't figure out the core principle of Xylocta, even Galaxy Pharmaceuticals' own researchers still couldn't figure it out...

The BFD103 project was never intended to be used to treat cancer. The original intention of the project team was to stimulate immune function, enhance metabolism, and help people regain their youth...

But no one would have thought that the BFD103 project was of little use in regaining youth, but it showed excellent targeted therapeutic effects on cancer.

As for why?
God knows why…they themselves are confused. So now if people ask the core researchers of the project that developed the drug to explain it, they can’t tell.

Xiluokeda is an anti-cancer drug that was discovered by chance after countless random attempts.

Galaxy Pharmaceuticals researchers don’t know more about the core mechanism of the drug than Roche researchers!
The mysteries of the human body far exceed people’s imagination!

So, even though Galaxy Pharmaceuticals has developed Xylocta, if you ask them to replicate a drug with a similar core principle now, they can’t do it…

Currently, Galaxy Pharmaceuticals' research on the drug is actually divided into two parts. One part is routine clinical trials, which is to find out various side effects, indications, conflicts with other drugs, etc.

The other part of the research is actually similar to the reverse research on Xiluokeda conducted by Roche and other pharmaceutical companies. It conducts in-depth research on the drug and tries to understand why this drug can treat cancer.

Once we understand it, we can try to use the same core principles to develop drugs for other diseases.

However, after several months of internal research, Galaxy Pharmaceuticals is still confused...the progress is not much better than that of Roche's research.

Scientific research itself has some metaphysical elements, and Herodectes is a typical example!

----

Many pharmaceutical companies, including Roche, have conducted more or less targeted research on Xiluokeda, trying to imitate this technology route to develop their own anti-cancer drugs or drugs to treat other diseases, but they face many difficulties.

Immunotherapy has become the hottest term in the global medical field in just two months, and countless pharmaceutical companies have flocked to try it out.

But without exception, they all encountered great difficulties.

Strong companies like Roche have figured out a way to synthesize in vitro, and can produce highly targeted but high-cost individual drugs, while some less powerful companies cannot even take this approach.

Galaxy Pharmaceuticals' Xiluokeda has opened a window for the human medical community...but when people look out through the window, it is still pitch black and they can't see anything.

Of course, these are the troubles that plague major pharmaceutical companies and the industry's top scientific researchers. But for ordinary cancer patients, they don't care how Xiluokeda is made or how high the technical content is. They only know that this drug can save lives.

Cancer patients in many countries are looking forward to Xiluokeda being launched in their own countries as soon as possible.

In this case, although Xiluokeda has not yet completed the second phase of clinical trials, some situations have been identified in the first phase of clinical trials. After ensuring basic safety, some countries are still ready to grant emergency approval for this drug.

After all, this is a drug that really concerns the lives of countless people.

Globally, there are 10 to 20 million new cancer patients every year. The global stock of cancer patients exceeds 50 million, and nearly 10 million people die every year.

Among the nearly 10 million patients who die each year, at least millions suffer from cancers that are indications for Xiluokeda... Although there are currently only 16 confirmed indications for Xiluokeda, these 16 cancers cover almost all common cancers.

Not all countries can sit idly by and watch so many people die.

Therefore, after China released the emergency license, in July, after many discussions and interest games, the UK officially announced that it would release the emergency marketing license for Galaxy Pharmaceutical's Xiluokeda.

The drug is approved for use in advanced cancer patients with less than a year to live.

Moreover, the use of this drug is limited to a few research hospitals with rich experience and treatment level, and prescriptions are issued after research by a treatment team composed of senior doctors.

The purpose of this emergency license is very clear, which is to save lives. If the patient is not in critical condition and does not need emergency life-saving, it still cannot be used... After all, no matter what, this is a drug that has not yet completed clinical trials.

If used for critically ill patients, no matter how big the side effects are, as long as it can cure the disease, it can be said that the benefits outweigh the costs.

However, if used in non-critical patients, the unknown risks may result in the benefits being less than the costs.

On the same day, Galaxy Pharmaceuticals Europe announced that its broad-spectrum anti-cancer drug Xiluokeda officially landed in the UK. The price of the local commercial medical insurance is 30,000 euros per course of treatment, equivalent to about 200,000 Chinese yuan.

Just after the UK announced the emergency approval for Xirokeda, Germany quickly followed suit and granted Xirokeda emergency approval.

Then comes France, followed by India and Japan.

This has led to most of the eight major countries around the world where Xeloda is conducting large-scale clinical trials having granted general emergency authorization.

Then the pressure came to the US FDA!

Initially, the FDA planned to continue playing the ostrich. After all, it was not them who died. However, if they approved the emergency license for marketing and any problems arose, they would definitely be the ones who would suffer.

Therefore, they did not pretend to be blind to the wishes of ordinary patients, but just said that they had created the best conditions to ensure the smooth implementation of the second phase clinical trial of Xiluokeda.

At the same time, they emphasized that any drug that wants to be marketed must undergo clinical trials, and they will never set a precedent in this field.

If there is Xiluokeda today, then tomorrow there will be other drugs that will also want to obtain emergency authorization under this name.

This will destroy the existing drug clinical and marketing system.

It sounds good, but many patients who are waiting for this drug to save their lives don’t care!

As a result, a large crowd began to gather in front of the FDA building. They were all cancer patients and their families, all of them sitting in protest in a miserable manner.

A mother was interviewed while holding her little girl who had cancer. The girl was only ten years old, very beautiful and cute, but she was already in the late stage of cancer.

When the mother was asked by the reporter, she replied sadly: "I just want to save my child. They said there was no other way before... But now, there is a way, there is Xiluokeda, but some people don't want us to use this medicine, and don't want us to live!"

The 10-year-old girl faced the camera and said something very heartbreaking in a very sweet and sad tone: "I just want to live. Is that wrong?"

This scene made many reporters and photographers who were interviewing the scene on the scene couldn't help but cry. There was even a female reporter who couldn't suppress her emotions and squatted on the ground crying after the interview.

Of course, there are also many journalists who put on a show... Journalists also want fame, and they want name. Crying for cancer patients, what a positive image!
After many reports came out, many viewers in front of the TV were heartbroken... Many people would subconsciously think of the scenes where their relatives or friends had cancer and then died!
By the way, the cancer prevalence rate is actually quite high. Almost everyone has relatives or friends who have suffered from cancer.

And when it was put on the Internet, it caused a huge discussion. Most ordinary people actually have the most basic sympathy... and since their interests are not related, they can naturally take a more neutral stance, or even directly look at the problem from the perspective of the disadvantaged.

Some public figures and even politicians who want traffic and fame have begun to get involved.

To give cancer patients hope of survival...how positive that sounds!
As a result, public opinion became even louder!

In this case, the FDA is under even greater pressure.

On the one hand, there is pressure from major pharmaceutical companies and their checks.

On the other hand, there is external pressure.

Finally, there are concerns about liability.

All these factors mixed together have put them in a dilemma!
(End of this chapter)