Chapter 112 Mr. Zhang, do you know about Novartis’ new drug? (Please subscribe!)
Friedman’s words are not an exaggeration.
Due to the early publicity of Novartis and the fact that each subject was still given a drug remuneration of US$5,000 for the Phase III clinical trials, all 400 places for the Phase III clinical trials were filled within three days, which is not an unsatisfactory speed. .
Such a hot scene has naturally attracted the attention of more American pharmaceutical giants.
In fact, Novartis has never been a pharmaceutical company that is also good at liver disease drugs. Novartis's strengths are leukemia, breast cancer, and cardiovascular and cerebrovascular drugs.
Why was a fatty liver treatment drug like “LivClearX” suddenly developed?
With curiosity and questions, many pharmaceutical companies began to check the FDA registration information of the new drug "LivClearX". After reading the detailed information, they were shocked!
In the filing materials submitted by Novartis, the source of the drug patent turned out to be Tsingshan Pharmaceutical (CN).
When any pharmaceutical company conducts clinical trials with the FDA, it is required to submit relevant data such as the drug's crystal form patent, animal experiments, and reporting companies.
If it is a drug developed by your own pharmaceutical company, then just submit relevant information normally;
If you are introducing drugs that are already on the market abroad, such as "ITG human genin" that is already on the market in China, you need to indicate the source of introduction after submitting patent and other information.
Since this new drug "LivClearX" has not been launched overseas, it is not an imported drug at all. You only need to fill in the application for clinical trial enterprise (Novartis) and the source of the patent (Tsingshan Pharmaceutical). !
This is a simple reporting rule of FDA, but it is not clear to those who are not industry practitioners.
New York, Gilead.
Looking at the registration information of Novartis' new drug "LivClearX" in front of him, the young vice president John shook his head in annoyance and surprise.
In fact,
When Qingshan Pharmaceutical just announced that it had discovered an active substance that can promote liver cell regeneration, they also noticed the news immediately.
But like most pharmaceutical companies, they were slightly shocked after seeing it, and then took it to heart, and were ready to wait for Qingshan Pharmaceutical to complete the second or even third clinical phase before deciding whether to introduce the drug. .
Unexpectedly...
Novartis got there first.
John rubbed his temples and looked at CEO Daniel, who was leaning on the leather sofa.
He and Daniel have been friends for many years.
“Daniel, I didn’t expect that Novartis is really brave.”
“Look at the time they applied for the new drug “LivClearX” almost at the same time as Qingshan Pharmaceutical’s promotion of the discovery of ‘liver activation’ The time of administration was consistent...
In other words, they should have contacted Qingshan Pharmaceutical as soon as they heard the news and obtained the agency rights for this drug. ”
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"Do they have that much trust in Qingshan Pharmaceutical? Aren't they afraid that this drug will not work and they will lose their money?"
President Daniel shrugged helplessly. He was also surprised by Novartis' decisiveness.
After a moment, he shook his head and said:
"John, I have known their president Green for more than ten years. He is a very traditional Englishman and very conservative. He will never do this. Such a radical choice”
“I guess it was their vice president Friedman who pushed it.”
"Friedman? That Jew?" Young John thought of that man's appearance.
“Yes.”
Daniel nodded slightly, with an indescribable look on his face.
“This Jew has a doctorate in finance and biology and a very radical personality. He has promoted several foreign investments of Novartis in the past few years.”
“It is entirely possible for him to risk this Risk.”
As he spoke, Daniel stirred the coffee in the cup with a spoon and sighed:
"But they made the right bet this time! What a good luck!"
"From the current situation of 'LivClearX' Clinical phase II and phase III data It seems that after long-term use, this drug does have a good inhibitory effect on liver function abnormalities, inflammation and other problems caused by fatty liver. This time they are going to make a lot of money."
The two of them finished speaking. They looked at each other and smiled bitterly.
In fact, Gilead has been developing drugs for "fatty liver", but fatty liver is not a virus, nor is it an autoimmune disease. It is purely a problem caused by excessive accumulation of fat, which makes it very It is difficult to find an effective breakthrough.
Fortunately, because there has been no good progress, Gilead has not invested much in the research and development of fatty liver drugs.
However, they know very well that
Once this drug that can treat fatty liver is launched, it will undoubtedly end the situation where the entire medical community is helpless against fatty liver.
This will bring countless money.
The two sighed with emotion. At this moment, young John suddenly reacted:
"Daniel, but I discovered an interesting thing. Both the media and ordinary people in our country are very enthusiastic about this drug, but they all seem to think that this drug was developed by Novartis."
< br>“I didn’t know that it was Qingshan Pharmaceutical that actually developed it.”
Daniel was slightly stunned, a little confused for a moment.
“Is this important?”
Daniel actually didn’t care about this matter.
It is normal for the pharmaceutical industry to introduce drugs from pharmaceutical companies from other countries, and most ordinary people will not pay attention to whether the drug is produced in the United States or Japan.
Even, let alone the place of origin, most ordinary people and even drug manufacturers don’t pay much attention to it.
Patients are more concerned about the effect of this medicine.
“I don’t know if it’s important, but I feel that the media and netizens are exaggerating the new drug ‘LivClearX’ too highly.”
As he spoke, John took out his mobile phone and quickly opened Twitter. Special, and then found some favorable replies in a message about the new drug "LivClearX".
"Daniel, look at this: 'This is undoubtedly a medical miracle, the light of human life, thank you Novartis, thank you FDA, thank you for bringing such a good new drug to the American people!'"
"And this Article: 'Novartis, you are like a ray of light in the darkness that brings us hope. I salute you and all the scientists in the United States who are involved in the development of this drug. It is your efforts that make me believe that America will be great again!' "
“Oh, Novartis, bring this new fatty liver drug to everyone in the world, let USA’s technology shine on the world!”
“Yes, especially China, let them Look, our America is still great!”
Daniel’s eyes widened as he watched. He snatched it from John’s hand and kept looking at it. After a few minutes, he suddenly burst into laughter. I couldn't help but feel a little bit evil in my heart.
"If these netizens know the truth one day... I'm afraid they will collapse, right?"
"Haha, I'm wondering now whether Novartis has noticed this problem."
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Of course Novartis has also noticed that with the start of Phase III clinical trials, more and more people on the Internet are beginning to tout LivClearX.
The wording even surprised Friedman.
Why didn't Novartis take the initiative to explain that this is a patented drug originating from China?
Who in advertising would take the initiative to say that this is someone else’s drug?
No.
Moreover, the drug itself has special properties. Patients are more concerned about the effect of the drug rather than which pharmaceutical company.
Novartis headquarters, in the office of the vice president.
"President Friedman, what should we do now?" "Although we have never actively promoted 'LivClearX' as our own research and development, both the media and ordinary netizens now assume that this drug was developed by us... ”
“Do you think we should issue a clarification announcement in time while the heat is still just beginning?”
Listening to the report of the public relations manager, Friedman said No words were spoken.
A minute later, he slowly looked away from the Twitter comments on the screen, and then rubbed his temples.
There are currently a lot of comments about the new drug "LivClearX" on Twitter. On the one hand, I did a lot of publicity work in the early stage;
On the other hand, there are too many patients with fatty liver disease in the United States!
With the start of the third phase of clinical trials, after more than a dozen subjects took the initiative to post some medication records on Twitter, everyone’s enthusiasm was completely ignited.
For a time, Novartis The words of praise and expectation are beyond words.
He is also very happy to see the good reputation created by this emotion, which will undoubtedly have an excellent effect on the sales and publicity of "LivClearX" in the future.
And if it is suddenly clarified that "LivClearX" was not developed by Novartis, but by China Pharmaceuticals, this will inevitably greatly reduce the entire market's attention to this drug.
This is a huge blow to Novartis!
After thinking for a moment, he shook his head and said:
“Don’t worry about it now, I’ll think about it later.”
“Well, if the president asks Get up?”
"I will communicate with the president, don't worry."
......
Just when Friedman and the entire Novartis were still wondering whether to take the initiative to clarify public opinion, Zhang Yang He has devoted himself wholeheartedly to the clinical phase II trial of "hepatocyte activator".
Because cirrhosis is a pathological change in the liver structure, countless liver cells have turned into sclerotic nodules covering the entire liver.
So, when the "liver activator" with a 70% effect was put into the second phase of clinical trials, patients still did not see obvious therapeutic effects immediately.
It was not until a month and a half after taking it that the first batch of patients finally felt some obvious differences from before.
When Zhang Yang has nothing to do, he will go to the Third People's Hospital to see Zhang Wenjun, and also learn about the clinical progress of the "liver activator".
"Liu Wenjun, come and eat an apple."
Zhang Yang did not call Liu Wenjun uncle because he was 52 years old. He still called him by his first name as before.
As a role model of the times, no one would think that Zhang Yang is ungrateful, or even take it for granted.
"Mr. Zhang, you are so flattering to me. I'm embarrassed that you did it yourself."
"It's okay, just eat."
Zhang Yang smiled, but he didn't care about this. , every time he saw Liu Wenjun, he became more determined in his original intention.
Yes, his original intention in developing the "hepatocyte activator" was to save countless patients with cirrhosis caused by hepatitis B across the country and bring them back from death!
Instead of... cutting leeks!
"Liu Wenjun, how are you feeling recently? Are you feeling better?"
"Much better."
Liu Wenjun smiled happily and took a bite of the apple, sighing:
" Mr. Zhang, especially in the past week, I have obviously felt that my appetite has improved. Chinese medicine says that a good appetite will clear up the qi and blood, and the liver will blood, indicating that my liver blood circulation is much better than before.”
“In addition, I have been worried about my gastrointestinal bleeding before, but after taking this medicine for the past two or three months, I have not had a single bleeding. , and my stools are not as black as before, and now my stools are quite normal.”
Zhang Yang nodded. He often came to visit Liu Wenjun, and of course he could see the changes in Liu Wenjun.
The reason why I asked this deliberately is because I hope Liu Wenjun can see his own changes and treat life more positively and optimistically.
"That's good! Don't worry, rest in peace and recuperate, you will get better day by day."
With that said, Zhang Yang stood up from the chair and patted Liu Wenjun on the shoulder.
"Then I'll leave first. I have to talk to Director Chen Wen and I'll see you next time."
"Okay, Mr. Zhang, please go slowly, Haoran, you see Mr. Zhang off."
Zhangyang walked out of the ward amidst the polite words of Liu Wenjun's son Liu Haoran, and immediately came to Director Chen Wen's office.
This is also one of his important tasks in the hospital.
Because the patients in the clinical trials of "promoting hepatocyte activator" are all patients with liver cirrhosis, a large part of them are in the "decompensation stage", and this group of patients themselves are in danger of life at any time.
Therefore, a large number of subjects simply lived in Chengdu Third People's Hospital, receiving clinical trials while being hospitalized.
This allows the hepatology department to have more accurate clinical data for this group of patients.
"Mr. Zhang, you are here, please take a seat."
Seeing Zhang Yang come in, Chen Wen quickly stood up and picked up a bench.
“You’re welcome, I can do it myself.”
Zhang Yang smiled slightly and sat down in front of the computer next to Chen Wen.
"It's still the same as before, how about the clinical data you have been tracking in the past half month?"
"Very good, the effect has been seen in the past half month!"
Chen Wendian Open a detailed data document, which is full of data about each clinical trial patient.
He continued:
“There are a total of 98 subjects this time. Because of the double-blind trial, we don’t know which ones are the experimental group and which are the control group. But after one and a half months of continuous administration, , now it is gradually showing some effect, and the data this week can clearly see the numerical difference among some patients.”
Zhang Yang looked slowly and saw that it was exactly what Chen Wen said.
Some patients began to experience significant decreases in transaminase and alpha-fetoprotein. Judging from the ultrasound diagnosis of liver ultrasound using imaging equipment, the elasticity of the liver also began to decrease slightly.
These data are not impressive at first glance, but batches of more than 30 people have shown a downward trend, while the indicators of the other 30 or 40 people have not changed. This is a clear contrast.
This shows that the drug has an effect after long-term use by the subjects who took the drug, and this is also the scientific part of clinical trials and double-blind testing.
“Okay, it seems that the current clinical data is that it takes at least one and a half months to have obvious effects. This time is a little longer than I thought.”
"But it's okay, Director Chen. Thank you for your hard work. I'll come back and take a look in half a month."
After Zhang Yang saw the data, he was about to leave. Chen Wen also stood up and was about to send Zhang Yang off.
But as soon as he walked to the door of the office, Chen Wen suddenly remembered something and said:
"By the way, Mr. Zhang, recently I noticed that many patients are discussing a drug, which is Novartis from the United States. A drug that also treats the liver."
"Look, do you know this drug?"
As he spoke, Chen Wen took out his mobile phone and found reports on Novartis' new drug "LivClearX" in the public account.
(End of this chapter)