After being fired, I became the light of medicine
Chapter 109 Friedman, you are a fucking genius
Chapter 109 Friedman, you are a fucking genius (Please subscribe!)
While a heated debate was going on within Novartis, the domestic company that had started Phase I clinical trials earlier than Novartis also received the clinical data results of the first batch one month later.
The clinical trial of Qingshan Pharmaceutical's "hepatocyte activator" was also carried out in Chengdu Third People's Hospital.
but.
Compared with Novartis's FDA trial, which recruited more patients with severe fatty liver and cirrhosis caused by fatty liver, the first batch of subjects in China were almost all patients with cirrhosis caused by hepatitis B.
There is no way, the national conditions of the two countries are different.
Chengdu Third People's Hospital, Clinical Trial Center.
Zhang Yang, Wei Tian, Feng Gang, as well as the director of the infectious department Chen Wen and the overseas returnee PhD Chen Yifei who had switched jobs, gathered in the conference room.
Because the tracking data of liver cirrhosis is not like blood diseases and hepatitis B virus, which have very clear biochemical indicators,
For example, for blood diseases, if the three blood counts such as platelets improve, it means there is a significant improvement; for example, for hepatitis B, if the viral load decreases and turns negative, it proves that it is effective.
There is no clear single indicator to judge patients with cirrhosis. Instead, the overall condition needs to be judged through testing of transaminase, alpha-fetoprotein, B-ultrasound, liver ultrasound (liver elasticity) and even liver biopsy.
Therefore, during the clinical trial stage, Zhang Yang invited Director Chen Wen and Chen Yifei to participate in this clinical trial.
"Let me first talk about the most intuitive blood data indicators."
"'Transaminase' and 'bilirubin' are the most important blood indicators for patients with liver cirrhosis. After one month of medication, the patients participating in the trial have seen a slight decrease compared to one month ago."
"The liver cancer marker 'alpha-fetoprotein' was also slightly downregulated in all subjects."
"From the data, this 'liver cell regeneration activator' does have some effect, but..."
“Not very obvious.”
The first person to speak was Feng Gang, who is also the project leader of this "hepatocyte activator" in clinical practice.
After saying that, he handed the thick stack of clinical data in his hand to Zhang Yang.
Zhang Yang was not surprised. After taking the clinical data, he smiled slightly and looked at Chen Wen beside him.
"Director Chen, where are the clinical data you are tracking?"
Chen Wen looked down at the notebook on the table, then said slowly:
"The clinical data that Chen Bo and I tracked is similar."
"The B-ultrasound, liver ultrasound and CT results of these 20 subjects after taking the medicine for one month showed no obvious characteristic changes compared with one month ago.
Some values have improved compared to before, but overall, the condition is stable and has not worsened.”
"At the same time, many patients said that they were in much better spirits than before, and their appetites were also a little better..."
"So, after comprehensive discussions with Chen Bo, we preliminarily determined that the drug has a certain effect in regenerating and activating the liver, but it may be far from the degree of reversing liver cirrhosis that we expected."
This judgment was quite reasonable, and Zhang Yang couldn't help but nod slightly.
He had psychological expectations for this result. After all, the actual therapeutic effect of "hepatocyte activator" is only 50% at present, and the patients it treats are all compensated or decompensated liver cirrhosis patients.
In addition, the trial period was only one month, so being able to control the condition and prevent it from getting worse was already a good result.
but.
Perhaps it was because Feng Gang and Chen Wen had high expectations for this drug, the atmosphere in the conference room became a little dull after they finished speaking.
Seeing this, Chen Yifei and Chen Bo at the side couldn't help but say:
"Director Chen, Director Feng, we can't ask such high standards of Mr. Zhang."
"After all, this drug is tested on patients with liver cirrhosis, which is very difficult to treat. In addition, there are still Phase II and Phase III clinical trials, and the drug ingredients can be slowly adjusted."
After Chen Bo said this, the two of them looked a little more relaxed.
Zhang Yang couldn't help but nodded with a smile:
"What Chen Bo said is correct. At present, our R&D center has made new progress."
"The first phase of clinical trials is mainly to test drug toxicity. When we enter the second phase of clinical trials, we will definitely continue to modify the drug composition, which will improve the therapeutic effect by about 15%."
After the words fell, the three of them were slightly stunned, and then Feng Gang's complaints were heard in the conference room.
"Mr. Zhang, you are too kind. Why didn't you tell me earlier about the new progress?"
"That's right! I worried for nothing."
"Haha, Mr. Zhang, please treat us today."
……
The data from the first month of the clinical phase I of the "hepatocyte activator" did not achieve significant results, not only in terms of data,
Twenty subjects with cirrhosis who participated in a Phase I clinical trial also felt the effect.
They originally had great hopes for this "hepatocyte activator", but after taking the medicine for a month, the subjects gradually calmed down.
Everyone realizes that cirrhosis of the liver is not a cold or fever, and even for Qingshan Pharmaceutical it is extremely difficult to reverse cirrhosis of the liver.
Therefore,
After a brief and heated discussion in the early stages, as the clinical results did not meet everyone's expectations, news about "hepatocyte activators" gradually became less common on the Internet, in forums, and in patient groups.
For a time, Qingshan Pharmaceutical's "hepatocyte activator" became "idle" and smoothly advanced its Phase I clinical trials.
A month later, the two-month Phase I clinical trial of the "hepatocyte activator" was completed, and Zhang Yang immediately submitted a Phase II clinical application to the approval center.
Just a few days later, far away in the United States, the "hepatocyte activator" led by Novartis also successfully completed the FDA Phase I clinical trial.
However, while Zhang Yang was still waiting for the domestic approval center to approve the Phase II clinical application for "hepatocyte activator", Novartis took the lead in bringing good news.
Novartis completed the Phase II clinical approval of the "hepatocyte activator" through the FDA's fast-track approval channel and will officially start the Phase II clinical trial soon.
"Approvals under capitalism are fast. Novartis still has some strength."
Zhang Yang couldn't help but sigh that Novartis is a latecomer and has made much more progress than domestic companies.
But it’s also good this way, it’s good for the “hepatocyte activator” to be launched overseas 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 accepted Friedman's request, but Friedman's first sentence after they met completely stunned him.
"Mr. Friedman, are you sure you don't need our improved drug samples? The current drug samples will do?"
"I am sure."
Friedman's eyes were firm.
Zhang Yang couldn't believe it:
"Friedman, this is a serious matter. I must confirm it with 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 right now." "The samples you provided are very good now."
At this time, Zhang Yang was sure that Friedman was not joking. He thought quickly, and at this time, Friedman continued:
"Zhang, this visit to Huaxia is not just about this matter. We also hope to change the original main treatment direction of this drug from 'liver cirrhosis, fatty liver' to 'fatty liver, liver cirrhosis'."
Zhang Yang was completely confused. To be honest, both the system manual and his original intention for this drug were to treat liver cirrhosis.
I didn’t expect that after a phase I clinical trial, Novartis would change its focus to treating fatty liver?
Friedman smiled at Zhang Yang's surprised expression and explained:
"Zhang, to be honest, when we were doing Phase I clinical trials at the FDA, we recruited 10 patients with severe fatty liver disease and found that it had a good therapeutic effect on patients with fatty liver disease."
"That's right. In the United States, there are far more patients with severe fatty liver than patients with cirrhosis. According to incomplete statistics, there are about 5000 million people with severe fatty liver in our country, and this number is still growing rapidly."
"Also, this drug is not unusable for cirrhosis of the liver. It also has a relieving and preventing effect on cirrhosis of the liver. It's just that after adjusting the main treatment direction to fatty liver, we can pass the approval faster. In subsequent advertising, we can also focus on fatty liver as a promotion."
It turned out to be the case.
Zhang Yang suddenly realized.
However, he soon realized that changing the treatment direction did not seem to conflict with updating the medication!
Could it be that better treatments cannot cure fatty liver?
At this moment, Friedman seemed to see through Zhang Yang's thoughts and suddenly said:
“There’s a conflict!”
As he spoke, a smile appeared on his lips:
"I know that your Phase I clinical trial is mainly used in patients with cirrhosis caused by hepatitis B virus, but our Phase I clinical trial is mainly used in patients with 'severe fatty liver' and alcoholic liver disease."
"The active ingredient of this drug can slowly reduce the transaminase of patients with fatty liver. After two months of taking it, liver inflammation begins to decrease and transaminase steadily decreases. According to our laboratory analysis, if the drug is taken continuously for one year, the transaminase of most patients with fatty liver can return to normal."
"Of course, as you know, the reason for the increase in liver transaminase is the accumulation of liver fat. As long as they stop taking the medicine, without the activating enzyme, their transaminase will inevitably increase."
“So, they need to take medicine all the time.”
"So, a drug that can be taken continuously and slowly improve fatty liver is just right."
Zhang Yang understood everything. He looked at Friedman deeply and then took a deep breath.
"I understand, but... are you sure that the current status of the 'liver cell activator' can pass clinical trials?"
"We're sure!"
Friedman was confident.
In fact, he was ready to talk to Zhang Yang about this matter as early as the third week of the clinical phase I results 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 phase of the clinical trial was completed.
The final test data was recognized by everyone. Qingshan Pharmaceutical's "cell activator" did have a significant improvement effect in the treatment of "fatty liver": the patient's transaminase and liver inflammation were significantly reduced after taking the medicine.
Don't underestimate this achievement. You should know that there is currently no drug in the world that can treat fatty liver.
As we all know, the hepatitis B virus can cause persistent inflammation of the liver, but this kind of inflammation only requires killing or inhibiting the hepatitis B virus, and the transaminase will quickly return to normal.
But what about fatty liver?
Myrrh.
There is no treatment for elevated transaminase levels caused by fatty liver, the only possible treatment is to lose weight.
And now,
This drug reduces the impact of fat on the liver in another way, allowing the liver to return to normal, which is definitely a blessing for obese people.
Thinking of this, he licked his lips.
"Zhang, don't worry. If the product fails to pass clinical trials and is put on the market, we will not only bear all clinical expenses, but also pay you an additional compensation."
"The board of directors has approved this matter."
Having said that, Zhang Yang couldn't refuse anymore. The attitude shown by Friedman or Novartis was indeed quite good.
"Okay, I agree with your request in principle. I will continue to promote the FDA's marketing certification with the current drug ingredients."
"Then we signed a supplementary agreement."
Friedman immediately broke into a bright smile.
"Thank you, Zhang, you are the best partner I have ever met."
Zhang Yang laughed and didn't take it seriously. Just as he was about to call Ren Xiaomin to come back and sign the supplementary contract,
Friedman suddenly changed the subject and said with a smile:
"Zhang, I actually suggest that you temporarily stop improving this drug in China."
"As far as I know, there are many patients with fatty liver disease in your country. Once the product is launched, it will surely be very popular!"
"Oh, yes, there are also a large number of patients with cirrhosis, but even patients with cirrhosis can take this drug."
"Wouldn't it be good to let them eat it for a long time?"
"After two or three years, you can bring a second-generation drug to the market that improves the therapeutic effect by 15%. If the first-generation drug sells for $500 a bottle, then you can sell the second-generation drug for $1000 a bottle."
"If there are three or four generations, we can sell them for $1500 or $2000. In this way, you can ensure that the latest drugs can be sold at higher and higher prices. Isn't that good?"
"By then, those patients will not only be grateful to you and willingly pay for the most expensive medicine, but the media on the Internet will also praise you for your continued investment in research and development, and even the government will praise your continued outstanding contributions..."
“This is a good thing that kills two birds with one stone.”
Zhang Yang was stunned when he heard this, then he looked at Friedman. After ten seconds, he suddenly said:
"You're a fucking genius."
Friedman laughed:
"Thank you for your compliment, but you may consider my suggestion."
Zhang Yang handed the next supplementary agreement to Ren Xiaomin, but to be honest, Friedman's words made Zhang Yang somewhat excited.
Friedman's sales strategy is indeed many times better than his own.
Continuous upgrades alone are enough to keep the price of this drug extremely high, and almost every update is another cycle of harvesting patients again.
He was moved.
But after a moment, he took a deep breath, and then he truly realized what it meant that a dragon slayer would eventually become a dragon.
It’s not that the boy wants to turn into a dragon, but that he has been with the capitalist for too long, and the capitalist will find ways to tempt the boy to turn into a dragon.
I was shaken after just chatting with Friedman for a while. What about those entrepreneurs who have been dealing with capital for years?
How tempted will they be?
……
PS: Thank you to Ma Jiahezi for the 5000 coins reward! Thank you!
(End of this chapter)
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