Chapter 109 Friedman, you are a fucking genius (please subscribe!)
While there was a fierce debate within Novartis, China, which launched the first phase of clinical trials earlier than Novartis, also received the first A batch of one-month clinical data results.
The clinical trial of Tsingshan Pharmaceutical’s “Hepatocyte Activator” was also launched at the Chengcheng Third People’s Hospital.
However.
Compared with Novartis’ FDA trial, which recruited more patients with severe fatty liver and cirrhosis caused by fatty liver, the first batch of domestic subjects were almost all patients with cirrhosis caused by hepatitis B.
There is no way, the national conditions of the two countries are different.
Rongcheng Third People's Hospital, Clinical Trial Center.
Zhang Yang, Wei Tian, Feng Gang, Chen Wen, director of the Department of Infectious Diseases, and Chen Yifei, a returnee doctor who had changed jobs, gathered in the conference room.
Because the tracking data of liver cirrhosis does not have very clear biochemical indicators like blood diseases and hepatitis B virus.
For example, if the blood data of blood diseases, platelets and other three systems are improved, that means there is Significant improvement; for example, for hepatitis B, the viral load decreases and becomes negative, which proves its effectiveness.
There is no clear and unique indicator for patients with liver cirrhosis. Instead, the comprehensive condition needs to be determined by testing transaminases, alpha-fetoprotein, B-ultrasound, liver ultrasonography (liver elasticity) and even liver puncture.
So, during the clinical trial stage, Zhang Yang invited Director Chen Wen and Chen Yifei to participate in this clinical trial.
“Let me talk about the most intuitive blood data indicators first.”
“‘Transaminase’ and ‘bilirubin’ are the most important blood indicators for patients with cirrhosis. After one month of taking the medicine , the patients participating in the trial had a slight decrease compared with one month ago."
"The liver cancer marker 'alpha-fetoprotein' also showed a slight decrease in the subjects."< br>
"Judging from the data, this 'activating agent that promotes liver cell regeneration' does have some effect, but..."
"It's not obvious."
The first person to speak was Feng Gang , he is also the project leader of this "hepatocyte activator" clinical project.
After saying that, he handed the thick clinical information in his hand to Zhang Yang.
Zhang Yang was not surprised. After receiving the clinical data, he smiled slightly and looked at Chen Wen aside.
"Director Chen, where are the clinical data you are tracking?"
Chen Wen lowered his head and glanced at the notebook on the table, and then said slowly:
"The clinical data tracked by Chen Bo and I are also Almost the same situation.”
“These twenty. The B-ultrasound, liver ultrasound and CT results of each subject after taking the medicine for one month did not show obvious characteristic changes compared with one month ago.
Some values are better than before. Overall, the condition is considered to be good. Smooth, no deterioration.”
"At the same time, many patients reported that their spirits were much better than before, and their appetite was a little better..."
"So, Chen Bo and I had a comprehensive discussion and preliminarily judged that this drug has a certain ability to regenerate the liver. The effect is far from reversing liver cirrhosis as we expected."
This judgment is relatively pertinent, and Zhang Yang can't help but nod slightly.
He had psychological expectations for this result. After all, the current actual therapeutic effect of "hepatocyte activator" is only 50%, and the patients it treats are all compensated or decompensated cirrhosis. Patients,
In addition, the trial period is only one month, and it is considered a good effect if it can be controlled without deterioration.
but.
Perhaps Feng Gang and Chen Wen had high expectations for this drug. After the words fell, the atmosphere in the conference room became a little dull for a while.
Chen Yifei and Chen Bo on the side couldn't help but said when they saw this:
"Director Chen, Director Feng, our requirements for Mr. Zhang cannot be so high."
"After all, This drug is being tested on patients with liver cirrhosis, and it is very difficult to treat. And there are still Phase II and III clinical trials, and the ingredients of the drug can be adjusted slowly.”
When Chen Bo said this, the two of them looked more relaxed.
Zhang Yang couldn't help but smile and nod:
"Chen Bo is right. At present, our R&D center has made new progress."
"Clinical Phase I The main purpose is to test the toxicity of the drug. When it enters the second clinical phase, we will definitely continue to modify the drug ingredients to increase the therapeutic effect by about 15%."
After the words fell, the three of them were slightly stunned, and the meeting continued. Feng Gang's complaints came from the room.
"Mr. Zhang, you are too kind. You didn't tell me earlier if there were new developments."
"That's right! I was worried for nothing."
"Haha, Mr. Zhang, treat me today."< br>
……
The first month’s data of the clinical phase I of “Hepatocyte Activator” did not achieve obvious effects, not only in the data,
Twenty cirrhotic subjects participating in a phase 1 clinical trial also felt it.
They originally had great hopes for this "hepatocyte activator", but after a month of taking the drug, the subjects gradually calmed down.
Everyone realizes that liver cirrhosis is not a cold or fever. Even if Qingshan Pharmaceutical wants to reverse liver cirrhosis, it is extremely difficult.
So,
After a brief and heated discussion in the early stage, as the clinical effect was not as good as everyone expected, news about 'hepatocyte activator' also appeared on the Internet, in post bars and patient groups. Gradually less.
For a time, Tsingshan Pharmaceutical's "hepatocellular activator" was "quiet" and was advancing the first phase of clinical trials calmly.
One month later, the two-month first-phase clinical trial of the "hepatocyte activator" was completed, and Zhang Yang immediately submitted a second-phase clinical trial to the approval center.
In a few days, far away in the United States, the "hepatocellular activator" led by Novartis also successfully completed the first phase of FDA clinical trials.
However, while Zhang Yang was still waiting for the domestic approval center to pass the second phase clinical application for "hepatocellular activator", Novartis took the lead in delivering good news.
Novartis has completed the Phase II clinical approval of "Hepatocyte Activator" through the FDA's fast-track approval process, and will officially start Phase II clinical trials in the near future.
"Capitalism's approval process is fast, and Novartis is still somewhat powerful."
Zhang Yang couldn't help but sigh, Novartis can be considered a latecomer, and its progress far exceeds that of China.
But it doesn’t matter if this is the case, it doesn’t matter if the “hepatocyte activator” is launched abroad first!
But at this moment, Zhang Yang suddenly received a call from the United States. Novartis Vice President Friedman wanted to meet with him again.
As a partner, Zhang Yang naturally readily accepted Friedman's request, but Friedman's first words after meeting him completely stunned him.
"Mr. Friedman, are you sure you don't need our improved drug sample? Just the current drug sample will be enough?"
"I'm sure."
Friedman's eyes firm.
Zhang Yang is unbelievable:
"Friedman, this is a serious matter, I must confirm it for you again... You may not know that our improved drug treatment effect can be increased by about 15% .”
Friedman's eyes remained firm and he nodded heavily.
"Zhang, we know, but we really don't need it at the moment." "The samples you provide now are very good."
At this time, Zhang Yang was convinced that Free Deman was not joking, he thought quickly, and at this moment , Friedman continued:
"Zhang, this visit to China is not only about this matter, we also hope to change the main therapeutic direction of this drug's original application from 'cirrhosis and fatty liver' to 'Fatty liver, cirrhosis' ”
Zhang Yang was completely confused. To be honest, both the system instructions and his own original intention of this drug were to treat liver cirrhosis.
Unexpectedly, after a phase I clinical trial, Novartis would change it to Treat fatty liver?
Looking at Zhang Yang’s surprised expression, Friedman smiled slightly and explained:
“Zhang, to be honest, when our FDA conducted the first clinical phase, we recruited 10 people with severe fat Liver patients, found to be a good treatment for patients with fatty liver "Yes, in the United States, there are far more patients with severe fatty liver than patients with cirrhosis. According to incomplete statistics, there are about 50 million people with severe fatty liver in our country, and this is The number is still growing rapidly.”
"Furthermore, it is not that this drug cannot be used for liver cirrhosis. It also has a relieving and preventive effect on liver cirrhosis. However, after adjusting the main treatment direction to fatty liver, we can get approval faster. For subsequent advertising, we You can also focus on fatty liver as propaganda.”
That’s it.
Zhang Yang suddenly realized.
However, he soon realized that changing the treatment direction did not seem to conflict with updating the medicine!
Could it be that fatty liver cannot be treated with better treatment effect?
At this moment, Friedman seemed to see through Zhang Yang’s thoughts and suddenly said:
“There is a conflict!”
As he said that, a smile appeared at the corner of his mouth:
< br>"I know that your clinical phase I is mainly used on patients with cirrhosis caused by hepatitis B virus, but our clinical phase I is mainly used on 'severe fatty liver' and "In patients with alcoholic liver disease"
"The current active ingredient of this drug can just slowly reduce the transaminase in patients with "fatty liver". After taking it for two months, the inflammation of the liver also began to decrease and the transaminase decreased steadily. According to According to our laboratory analysis, if the drug is continued for one year, the transaminases of most patients with fatty liver can return to normal.”
"Of course, you also know that the cause of elevated liver transaminase is liver fat accumulation. As soon as they stop taking the medicine and without the activating enzyme, their transaminase will inevitably increase."
"So, they need to continue to Take medicine.”
“So, a medicine that can be taken continuously and slowly improve fatty liver is just right.”
Zhang Yang understood completely, and he looked at Free deeply. Deman glanced, then took a deep breath.
"I understand, but...are you sure that the current drug status of the 'hepatocyte activator' can pass clinical trials?"
"We're sure!"
Friedman was confident.
In fact, he was planning to come to Zhang Yang to discuss the matter as early as the results of the third week of the first clinical phase came out.
But in the end, at the suggestion of President Green and Coles, they continued to observe for another month and a half until the first clinical phase was completed.
The final test data was recognized by everyone. Tsingshan Pharmaceutical's "cell-promoting activator" did have a significant improvement effect in the treatment of "fatty liver": the patient's transaminase, the inflammatory process of the liver It was significantly reduced after taking the medicine.
Don’t underestimate this result. You must know that currently, no drug in the world has any therapeutic effect on fatty liver.
As we all know, hepatitis B virus can cause continued inflammation of the liver, but this inflammation only needs to be killed or inhibited by the hepatitis B virus, and the transaminases will quickly return to normal.
But what about fatty liver?
Myrrh.
There is no treatment for elevated transaminases caused by fatty liver. The only possibility is to lose weight.
And now,
This drug reduces the impact of fat on the liver in another way and allows the liver to return to normal. This is absolutely great news for obese people.
Thinking of this, he licked his lips.
"Zhang, don't worry, if we fail to pass clinical marketing, we will not only bear all clinical expenses, but also compensate you an additional compensation."
"The board of directors is not satisfied with this matter. Already approved.”
Having said that, it was impossible for Zhang Yang to refuse anymore. The attitude shown by Friedman or Novartis was indeed not bad.
“Okay, I agree in principle with your request, and we will continue to advance the FDA’s marketing certification with the current drug ingredients.”
“Then we will sign a supplementary agreement.”
A bright smile suddenly appeared on Friedman’s face.
“Thank you, Zhang, you are the best partner I have ever seen.”
Zhang Yang laughed and of course didn't take it seriously. Just when he was about to call Ren Xiaomin to come back and sign a supplementary contract,
Friedman suddenly changed the subject and said with a smile:
"Zhang , in fact, I also suggest that you can temporarily stop improving this drug in China. "
"As far as I know, there are many patients with fatty liver in your country, and it will definitely be popular once it is launched!"
"Oh, by the way, there are also a lot of cirrhosis of the liver. patients, but even patients with liver cirrhosis can take this medicine.”
"Isn't it good to let them take it for a long time?"
"Wait two or three years, and then you will bring a second-generation drug with a 15% improvement in therapeutic effect to the market. If the first-generation drug sells for $500, If you buy one bottle of the second generation, you can sell it for US$1,000.”
“If there are three or four generations, we can sell it for US$1,500 or US$2,000. Come on, you can guarantee that the latest drugs will become more and more expensive. Isn’t this good?” The media on the Internet will also praise you for your continued investment in research and development, and even the government will praise you for your continued outstanding contributions..."
"This is a good thing."
Zhang Yang was stunned when he heard this, and then he looked at Friedman. After ten seconds, he suddenly said:
"You are such a fucking genius."
Free. Deman laughed:
“Thank you for your compliment, but you can consider my suggestion.”
The next supplementary agreement was handed over to Ren Xiaomin, but there is one thing to say, Friedman's words made Zhang Yang a little moved.
Friedman's sales strategy is indeed many times better than his own.
Continuous upgrades alone are enough to keep this drug at an extremely high price. Almost every update is another cycle of reaping patients.
He was moved.
But after a moment, he took a deep breath, and then he truly realized what it means that the boy who slays the dragon will eventually turn into an evil dragon.
It’s not that the young man wants to become a dragon, it’s that he has been with the capitalist for a long time, and the capitalist will try his best to seduce the young man into becoming a dragon.
I just chatted with Friedman for a while and my heart was shaken. What about those entrepreneurs who have been dealing with capital all year round?
How tempted will they be?
……
PS: Thank you to Majiahe for the big reward of 5,000 coins! Thanks!
(End of this chapter)