Rebirth 08: Rise from copycat phones

Chapter 352 Hailan Automobile is caught in negative public opinion
As of mid-July, seven of the eight countries around the world that are conducting clinical trials for Galaxy Pharmaceuticals' Xiluokeda have approved emergency authorization. At the same time, many countries have also taken the initiative to invite Galaxy Pharmaceuticals to conduct clinical trials in their countries.

And the clinical trials are not being conducted from scratch. Instead, simplified clinical trials are being conducted directly based on the existing first and second phase clinical trials in various countries, and emergency licenses are being granted based on the results of the simplified clinical trials.

After all, cancer patients are of all nationalities. People from all countries can get cancer, and there are also a large number of cancer patients in their country waiting for this drug to save their lives.

Direct approval for marketing is not possible, but it is possible to grant emergency licenses that are extremely restrictive and only last for six months or a year.

Against this backdrop, more and more cancer patients and their families gathered in front of the U.S. FDA building, which also attracted a large number of media reports.

This kind of behavior of gathering together to petition is different from ordinary strikes and demonstrations, and the public has very high sympathy for it.

This naturally puts many patients, their families, and even media reporters on the moral high ground.

"I want to live, is there anything wrong with that?" The question asked by a ten-year-old girl with cancer broke the defenses of countless people around the world.

Yes, I just want to survive, is there anything wrong with that?
The media reported on it every day, there was a huge discussion on the Internet, and even some ordinary people began to organize themselves and took to the streets to support these cancer patients.

Under tremendous external pressure, the FDA held several internal meetings in succession.

In the initial internal meetings, many FDA officials were very tough. Rules are rules and they cannot be broken just because of Xiluokeda.

If they must break it, then the higher-ups must issue a document with legal effect, such as passing a proposal, and then the FDA will enforce it.

But the people in higher-ups are not stupid, so how could they possibly endorse the FDA...they wouldn't be so stupid as to bring disaster upon themselves.

Again, if something happens after Xiluokeda passes the emergency permit this time, it will be very serious. Who will bear the responsibility then?
The gentlemen naturally stayed away.

Then the top brass at the FDA also played dead, and the opinions of the middle and lower level staff were irrelevant.

However, as more and more patients gathered outside the FDA, public opinion became increasingly negative, and even some ordinary people gathered, the FDA's attitude was gradually changing.

But...drugs must undergo complete clinical trials before they can be marketed. This is the FDA's bottom line and there is no possibility of change.

But above the bottom line, there are still some room for flexibility.

Soon, the FDA required Galaxy Pharmaceuticals to submit relevant data results from the Phase II clinical trial, and to a certain extent allowed Galaxy Pharmaceuticals to submit Phase II clinical trial data conducted in other countries as a reference.

You should know that at this time, the second phase clinical trial of Xiluokeda was only halfway launched.

As a result, after the FDA reviewed the Phase I and Phase II clinical trial data of Xiluokeda in the United States and several other countries, it immediately approved Galaxy Pharmaceuticals to conduct a one-month Phase III emergency clinical trial to verify the treatment effect and potential side effects on critically ill cancer patients.

Once the third phase of emergency clinical trials is passed, the FDA will grant Xiluo Keda a one-year temporary marketing authorization. This temporary marketing authorization is also highly targeted, only for critically ill cancer patients with the existing sixteen indications.

Please note that in this entire process, the FDA did not actually violate their procedures. They simply shortened the time of Galaxy Pharmaceutical's Phase III clinical trial and will grant marketing authorization after the drug passes this emergency Phase III clinical trial.

This is totally in line with their programming!

At the same time, while granting this emergency clinical trial, Xiluo Keda still needs to proceed step by step with the second phase and subsequent third phase of regular clinical trials for common cancers. It is expected that all clinical trials will be completed and a complete marketing authorization will be obtained by the middle of next year.

To put it bluntly, the FDA is acting like a jerk by forcing Galaxy Pharmaceuticals to conduct a so-called emergency Phase III clinical trial to verify previously verified side effects, drug conflicts, and efficacy on critically ill patients...and these trials have actually already been conducted during the Phase I and Phase II clinical trials.

Galaxy Pharmaceuticals naturally readily agreed to this... The FDA found a way out for itself, held many internal discussions, and looked through many laws and regulations before finally coming up with such a solution.

Galaxy Pharmaceuticals naturally had to take up this role and also praised the FDA's rigor and open-mindedness.

In short, you are fine, I am fine, and everyone is fine!

At the same time, this also made many cancer patients breathe a sigh of relief. Although they still need to wait for a month, it will be over if they endure it.

Furthermore, Galaxy Pharmaceuticals also announced that it will conduct an additional Phase II clinical trial for some patients with indications whose survival period is less than one month, grant clinical trial quotas, and provide free clinical trial drugs...

Of course, the number of additional places is extremely limited, only about 200 in total, and is mainly used for advertising and to collect some clinical trial data.

Because of its special nature, Xiluokeda has been given a break by drug regulatory agencies in many countries, which have approved emergency licenses or temporary licenses similar to those of the FDA. This is impossible to see with conventional drugs.

The reason why Xiluokeda was able to obtain these emergency approvals is because of its life-saving properties... A large number of terminally ill cancer patients who are about to die are waiting for this drug to save their lives!

In this case, few people dare to block the emergency temporary approval of this drug.

Otherwise, God knows what those huge number of terminally ill cancer patients who are in a state of despair and anger will do.

After the FDA found a way out for itself, drug regulatory agencies in many other countries also announced that they would invite Galaxy Pharmaceuticals to bring Xiluoke to their countries for emergency clinical trials, and then grant temporary emergency licenses.

Three days later, the European Medicines Agency, or EMA, also announced that it had approved Galaxy Pharmaceuticals' application for a one-month emergency clinical trial, and would decide whether to approve the emergency temporary license one month later depending on the situation.

Once approved, Xiluokeda will be granted emergency temporary permission throughout the EU, rather than individual permission in only some EU countries as before.

If nothing unexpected happens, Xiluo Keda will be launched in the seven existing countries with emergency temporary authorization one month later, and will also obtain emergency temporary authorization and be launched in many more countries including the United States and all EU countries.

And this coverage will continue to expand. Galaxy Pharmaceuticals is now launching emergency clinical trials in major countries around the world... Of course, the so-called emergency clinical trials in most countries have greater symbolic significance. Basically, they just select a few dozen lucky people to conduct clinical trials.

It is impossible to conduct large-scale clinical trials like in major market regions such as China, the United States, the European Union and Japan... it costs too much.

Most countries' attitude towards Xylokeda is to directly refer to the situation of FDA or EU EMA. As long as these two major markets approve Xylokeda, they will also approve it...

As a result, this also led to an extremely special situation in Xiluokeda!

The drug's routine clinical trials in the United States are still in the second phase, which is expected to take more than two months to complete. The third phase of clinical trials will not be launched until winter unless something unexpected happens, and is expected to be completed by the middle of next year.

But... at the same time, it has obtained emergency authorization in many countries, or "short-term emergency clinical trials" that require taking off pants to fart. As long as this emergency clinical trial is completed, it can obtain temporary marketing authorization.

This means that Xiluokeda has not completed formal clinical trials, but has already started to be sold, and the sales volume is huge...

Because there are many cancer patients in the advanced stage!

A piece of data: there are about 20 million new cancer patients every year, but the existing cancer patients are only about 50 million... Why are there so few existing patients?

Because when most cancer patients are discovered, they are actually already in the middle or late stages... There are no obvious reactions in the early stages of cancer, and unless you experience it frequently, it is difficult to detect. By the time it is discovered, it is often already in the middle or late stages.

This means that among the cancer patients who have been discovered, quite a number are in the late stage, and quite a number of mid-stage patients will also develop into late-stage patients within a few months or a year or two.

Therefore, the average survival period of newly discovered cancer patients is very short, only two or three years, which ultimately leads to a very small number of cancer patients.

What does this mean for Hirokoda?
This means that even under emergency authorization, there are still a large number of patients around the world who need this drug to save their lives.

When it is finally reflected in the sales volume of Xiluokeda, it will be very huge.

In June, when emergency approval was only granted domestically, Galaxy Pharmaceuticals estimated that Xiluokeda's revenue this year would be approximately US$4 billion.

However, as more and more countries grant emergency authorization, especially in the United States, a major market for original drugs, the FDA has also taken a roundabout route and is preparing to grant a temporary emergency authorization next month, which will lead to a sharp increase in the sales of Xiluokeda this year.

An American analysis and statistics company specializing in pharmaceutical market research and statistics released a market forecast report on global anti-cancer drugs in mid-July.

The report shows that under the current situation, as more and more countries grant emergency authorization to Xiluo Keda, Xiluo Keda's sales are expected to reach 15 billion US dollars this year, directly becoming the world's best-selling anti-cancer drug.

In terms of sales, it is second only to adalimumab, the world's leading drug.

By the way, the drug adalimumab is also very powerful. It is used to treat autoimmune diseases, namely rheumatoid arthritis, ankylosing spondylitis, and psoriasis.

As a drug that was launched in 2002, it is still very strong after more than ten years and has become the world's leading drug. Its annual sales can reach more than billion US dollars, and the market is still gradually growing.

Even though the core patent of this drug has expired this year, there will still be no competitors in the short term... because this drug is also a biological macromolecule drug!
As we all know, monoclonal antibodies are basically biological macromolecule drugs, which are extremely difficult to copy. This is why many large pharmaceutical companies like to develop biological macromolecule drugs... It can effectively avoid the impact of generic drugs.

By the way, Galaxy Pharmaceuticals is also developing these drugs based on autoimmunity...

Backed by Galaxy Life, Galaxy Pharmaceuticals has very in-depth research in the field of human immunity and has sufficient technical reserves and R&D experience.

One of the generic drug research projects is adalimumab.

Because the core patent of adalimumab is about to expire this year, anyone can imitate it now, so Galaxy Pharmaceuticals has also launched domestic imitation of this drug.

The reason for copying this drug is that it is more expensive than Xiluokeda...

The annual cost is about 200,000 yuan, but this medicine needs to be taken for life. 200,000 yuan a year, year after year, is enough to stop countless people from taking it.

Two hundred thousand dollars a time to cure the disease, medical insurance, patients, and family members, all grit their teeth and accept it... This is also the reason why Xeloda can enter major medical insurance markets. Although it is expensive, it will be almost the same after a few courses of treatment, and there is no need to take medicine for life.

Therefore, many medical insurance institutions have included Xiluokeda in the reimbursement scope after comprehensive consideration!

At the same time, many families of cancer patients had already given up on treatment, and were not prepared to throw themselves into this bottomless pit that was bound to leave them without money and lives... But after the emergence of Xirokeda, many cancer patients and their families had new hope, and were ready to grit their teeth and continue to hold on.

After a few courses of treatment, which costs hundreds of thousands of yuan, the disease can be cured, and a large part of the cost will be reimbursed by medical insurance. This is affordable for many cancer family members.

But adalimumab costs 200,000 yuan per year and needs to be used for a lifetime, which is really unaffordable...

Galaxy Pharmaceuticals is developing a generic version of adalimumab in order to enter this market. If it can be successfully developed and the price can be lowered, it can be included in the medical insurance, which will benefit patients and make a lot of money for itself.

It is difficult to make huge profits from making such extremely difficult generic drugs, but it is not a problem to make a small profit.

Especially for a manufacturer like Galaxy Pharmaceuticals, which has very in-depth research and technical reserves in the field of human immunity, although it is difficult to develop generic drugs such as adalimumab, it does not mean that it cannot be developed.

Whether it is Xiluokeda or Adalimumab, these are all drugs in the field of immune function and are also biological macromolecule drugs.

This also means that biological drugs developed based on the immunology field have become the current mainstream, and a large number of pharmaceutical companies are entering this field.

The most successful one is still Galaxy Pharmaceuticals' Xiluokeda!

Foreign analysis agencies believe that even with emergency approval this year, Xiluokeda can achieve sales of US$15 billion.

By next year, after it is officially launched on the market in some countries, its sales are expected to quickly exceed 30 billion US dollars, making it the veritable king of medicine in the world.

As for the exact sales volume, it depends on how many countries approve the drug for official marketing. Such outstanding achievements, coupled with the special nature of cancer, have also made Xiluokeda and the company behind it, Galaxy Pharmaceuticals, frequently appear in the media and become a topic of discussion.

At the same time, this also allowed Galaxy Pharmaceutical to quickly emerge and become a large pharmaceutical company that people paid close attention to. Many people have directly regarded Galaxy Pharmaceutical as a large multinational pharmaceutical company.

Its core products cover markets in major countries, and its annual revenue is approaching tens of billions of dollars. If this isn’t a multinational pharmaceutical company, what is it?
What will Galaxy Pharmaceuticals do after it becomes rich?
Increased investment in research and development!
In June and July, Galaxy Pharmaceuticals recruited top R&D talents on a large scale from around the world to carry out various research projects.

The R&D centers in Europe, the United States and China's three R&D centers are all recruiting large numbers of talents to engage in the R&D of various drugs or medical devices.

However, after the news about Galaxy Pharmaceuticals spread for a few days, it gradually died down… After all, most people don’t have cancer, let alone people in the industry.

It is already the limit to participate in short-term discussions when it does not concern you. It is impossible to keep paying attention to it every day.

People were soon attracted by many other news.

Among them is the frequent negative news about Hailan Automobile, which has recently caused a stir and attracted much discussion.

In mid-July, an Hailan SEC was involved in an accident in the United States. The violent collision caused a fire and the owner of the car died. This was originally a routine accident, but some people seized the opportunity and fanned the flames in public opinion, claiming that Hailan cars were not safe.

Soon after, it was revealed that Hailan Automobile's autonomous driving function would collect terrain data, driver and passenger privacy data and upload them to Hailan Automobile's database, which would lead to serious data leaks!
Some media outlets claim that every sea-blue car driving on American streets is a spy car that is constantly on the move, continuously collecting and leaking American terrain data.

It is obvious at first glance that this move was made by traditional car manufacturers, and Tesla is probably also involved.

As for collecting data for espionage... that's pure slander.

It’s not that HaiLan Auto doesn’t collect data. In fact, HaiLan Auto does collect data, but it is all used for autonomous driving AI training.

It's not used to spy on the terrain or anything like that, and there's no need for that.

Even if you want to get some terrain intelligence... you can just look at commercial satellite maps or even maps from map software, there's no need to go through the trouble of collecting it...

Today's commercial satellite maps are of very high definition, so you can see everything. The map software also contains a wealth of specific terrain information and can even provide you with a 3D mode.

The map software used by Hailan Automobile is Zhiyun's Amap by default. However, if some overseas places with greater restrictions do not allow your Amap to enter and collect data, then you can use Google Maps or maps from local companies.

By the way, Amap, a subsidiary of Zhiyun Group, has gradually spread its map services around the world over the years as Zhiyun mobile phones have been launched overseas.

High-precision map navigation services can be provided in most countries... Of course, there are some countries or regions where the market cannot be entered... In places where the market cannot be entered, Google Maps or maps from other manufacturers are generally used as a substitute.

As for personal privacy, these are all clearly written in the user agreement. Users agree that HaiLan Automobile collects various types of driving data for AI training of intelligent driving technology, and then they can turn on the assisted driving function... otherwise it cannot be turned on.

So, if you trust it, turn it on; if you don’t trust it, don’t turn it on.

Even if you don't use the autonomous driving function, the Hailan car is still good as an electric car: its battery life, acceleration capability, terrain adaptability, comfort and safety are all top-notch.

The sale of Hailan cars in various countries complies with the laws of each country...including assisted driving, which has been approved.

If it fails to obtain approval, HaiLan Automobile will not be able to go public.

Now some media are seizing on things like data security, personal privacy, and national defense security, and are also reporting negative news like Hailan cars are unsafe, catch fire, and explode.

As soon as the marketing staff of HaiLan Automobile saw the negative news, they knew with their eyes closed that it was a smear campaign by competitors... HaiLan Automobile was not surprised by this, after all, they often do this themselves and have smeared Tesla and other traditional car manufacturers' gasoline cars.

With the rise of HaiLian Automobile, competition with Tesla and other traditional fuel vehicle manufacturers has become increasingly fierce.

Recently, Hailan Automobile and Tesla have been competing with each other in the European market... because Tesla is preparing to build a factory in Europe and expand the European market.

Hailan Automobile is also preparing to build a factory in Europe to expand its share in the European market.

At the same time, some traditional European car manufacturers are extremely wary of these two outsiders and have taken various measures to obstruct them.

Similar situations have also occurred in many regions. Even in China, Hailan Automobile is actually facing a lot of smears and obstacles from traditional oil vehicle manufacturers.

Under such circumstances, some negative news about Hailan Automobile appeared both at home and abroad...

It's business competition, this is normal.

In response to this, HaiLan Automobile will also conduct a relative public opinion counterattack... Of course, it is not a simple excuse. In fact, the more you explain this kind of thing, the more difficult it will be to deal with.

The best way is to completely confuse the situation and drag all competitors into the water.

Who doesn't have a few black spots? Whether it's Tesla's competitors in the electric vehicle field, or those traditional car manufacturers, there are so many black spots. Just grab a few of them, then invest marketing funds in hype, and you can get the pace up in minutes.

Once the situation becomes chaotic, naturally no ordinary people will keep an eye on the Hailan car!
Even the most rational group of people, upon seeing this situation, can only say: All crows are black, and none of them are good people!

Or you can try to prepare with other hot news, just find a piece of news with explosive points, and then invest money in publicity to divert the attention of netizens.

As long as the attention is diverted, it will be a perfect public relations event!

HaiLian Automobile is very good at this. After all, as the first new manufacturer in the world to mass-produce electric vehicles, focusing on pure electric models and developing autonomous driving technology, it has been accompanied by countless controversies since the day it was born.

Even in China, there are many controversial voices.

Therefore, Hailanche is extremely experienced in handling public relations of negative news.

So, there were all kinds of negative news about HaiLan Automobile at first, but a few days later, it turned into a concentrated outbreak of negative news about HaiLan Automobile and other automobile manufacturers. In the United States and Europe, there were also various news about the fierce competition between Tesla and HaiLan Automobile.

About ten days later, Hailan Automobile completely calmed down the situation and allowed everyone to return to the same starting line.

Xu Shenxue was more concerned about the situation at Hailan Automobile: "We need to strengthen public relations and establish a news warning system in major markets. We need to try our best to nip things in the bud. Even if we can't suppress it for the time being, we need to control the situation as much as possible. If we can't control it, then we have to muddy the waters!"

"If it doesn't work, just post news about celebrities getting married, getting divorced, cheating, etc. to divert attention!"

"In short, we can't just do nothing and let the situation get worse!"

"The smart electric vehicle market is developing rapidly now. It is a critical period for us to carry out global market layout. We cannot allow any major unexpected situations to occur. We must nip all dangers in the bud!"

Bao Yongyan also said: "After our analysis, the occurrence of this incident is mainly caused by our mid-size sedans entering the global market one after another and the continued hot sales!"

"The continued popularity of our Hailan SLMC has aroused the high vigilance of many traditional automakers. Some of the electric vehicles launched by these traditional automakers have poor performance and high prices. It was not bad before because our Hailan cars were more expensive... But after our Hailan cars launched mid-size sedans and lowered the price to 400,000, these traditional automakers' electric vehicles felt huge pressure!"

"Many large domestic and foreign manufacturers' new energy vehicle models have been squeezed by our Hailan SLMC, and their sales have declined to varying degrees. This time is also their counterattack!"

“It also attracted the attention of Tesla, our main competitor in the electric vehicle field!”
"Traditional car manufacturers are afraid that we will further penetrate and swallow up the 300,000 or 400,000 yuan market, and Tesla has also been trying to make cheaper mid-range models, which constitutes direct competition with us!"

"Now we, Hailan Automobile, are facing a large number of competitors both at home and abroad!"

Bao Yongyan was a little speechless when he said this... He was just making an electric car, but he was almost making himself the public enemy of the earth.

Overseas, a large number of overseas automobile manufacturers have surrounded and slandered HaiLan Automobile in various ways.

The situation in the country is no exception. A large number of overseas automobile manufacturers have also spread rumors and slandered HaiLan Automobile.

What about privacy, data security, battery fires, new energy subsidies, batteries being environmentally unfriendly, electric vehicles not paying road maintenance fees and other taxes, anxiety caused by poor battery life of electric vehicles, etc.

They spread all kinds of rumors and smear campaigns in almost every direction they can find!
why?
Because the previous Hailan car was just a high-end science fiction toy in everyone's eyes. Although it was awesome in many ways, it was too expensive and too far away from ordinary people... This also meant that the previous Hailan car models seemed to be popular for a while, but in fact the sales could not be maintained.

Subsequent actual situations also proved this point. After the initial popularity, the sales of Hailan SEC and Hailan SEV have been halved and continued to decline, entering the sales state of conventional high-end models... The global market sales volume is only about a few hundred thousand or a few hundred thousand, which has no impact on any manufacturer.

But after the HaiLan SLMC came out, all major automobile manufacturers suddenly changed their attitude towards HaiLan automobiles!

And this attitude became worse and worse after HaiLan SLMC continued to lower its prices!

Last year, the price of Hailan SLMC was 400,000 yuan...but after this year's summer launch, the starting price of Hailan SLMC has reached 360,000 yuan.

Moreover, judging from Hailan Automobile's efforts to promote large-scale mass production and lower battery prices, it is estimated that by next year Hailan SLMC will be able to lower the starting price to around 300,000 yuan.

And this will pose a huge threat to the current mainstream automobile manufacturers!
Because the Hailan car has never been a car in the conventional sense. Its science fiction attributes outweigh its car attributes... Countless people swallowed their saliva as they looked at the Hailan car's automatic driving function.

But they couldn't afford it before. Although there was a low-end version of the Hailan SEC in China priced at 450,000 yuan, it was actually impossible to buy the Hailan SEC at this price.

Because you want to use 450,000 to buy the Ocean Blue SEC, but you find that it is out of stock...

Generally speaking, the price is around 600,000 for a 500,000 yuan version plus 100,000 yuan for an automatic driving function, and this does not include various optional features on the exterior.

Large SUVs like the Hailan SEV are more expensive, basically costing 700,000 or 800,000 yuan.

Not to mention large sedans like the Hailan SLC, which are exclusively available to wealthy bosses and cost more than one million.

So everyone knew that Hailan cars were awesome before, but because of the high price, many high-income groups couldn’t afford them.

And now, HaiLan Automobile has launched a HaiLan SLMC, and the price of this model continues to drop... As the cost of power batteries drops, HaiLan Automobile has lowered its prices twice in a row, bringing the starting price directly down to 360,000.

This version priced at RMB 360,000 is also equipped with an assisted driving function based on a pure visual solution, which makes it very convenient for daily family use.

There are currently two versions of Hailan Automobile's assisted driving technology. One version is a low-cost pure visual solution, which is standard and is installed in all models for free use. You will not be charged extra.

The other is 'Advanced Automatic Assisted Driving', which is a fusion solution of LiDAR and vision. This is a high-level and high-cost solution that can provide excellent automatic driving functions. This is an optional solution that requires an additional payment of 100,000 yuan!

At the same time, for the above two solutions, all models of Hailan Automobile have left room for subsequent upgrades at the beginning of their design. They can be equipped with better autonomous driving capabilities through subsequent hardware upgrades, mainly lidar, cameras and computing chips, as well as software upgrades.

Of course this requires payment, and it is quite expensive.

The Hailan SLMC, with a starting price of RMB 360,000, also comes with standard equipment, which is barely good, at least it can beat Tesla's pure visual autonomous driving solution!
This is very attractive.

This has attracted a large group of middle- and high-income groups to drool and want to buy a sea-blue SLMC to experience the feeling of black technology!
And this has caused many car manufacturers to panic!

This is also the reason why various negative comments about Hailan Automobile have frequently appeared since this year!

Because Hailan Automobile has already put its spoon into their bowl!
(End of this chapter)