After being fired, I became the light of medicine

Chapter 112 Mr. Zhang, do you know Novartis' new drug? (Please subscribe!)

Friedman was not exaggerating.

Due to Novartis' early publicity and the fact that the Phase III clinical trial still gives each subject a trial fee of US$5000, all 400 places in the Phase III clinical trial were filled within three days, which is quite fast.

Such a popular scene naturally also attracted the attention of more American pharmaceutical giants to "LivClearX".

In fact, Novartis has never been a pharmaceutical company that excels in liver disease drugs. Novartis' strengths are leukemia, breast cancer, and cardiovascular and cerebrovascular drugs.

How did a fatty liver treatment drug like “LivClearX” suddenly get 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 all 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 at the FDA, it needs to submit relevant data such as the drug's crystal form patent, animal experiments, and the declaring company.

If it is a drug developed by your own pharmaceutical company, then you can just submit the relevant information normally;
If you are introducing a drug that has already been launched overseas, such as "ITG human genotyping factor" that has been launched in China, you will need to indicate the source of introduction after submitting patent and other information.

Since this new drug "LivClearX" has not been launched overseas, it does not belong to an introduced drug at all. You only need to fill in the clinical trial application company (Novartis) and the patent source (Tsingshan Pharmaceutical)!

This is a simple reporting rule from the FDA, but it is not something that industry practitioners are completely aware of.

Gilead, New York.

Looking at the filing documents for Novartis' new drug "LivClearX" in front of him, the young vice president John shook his head in annoyance and surprise.

Actually,
When Tsingshan Pharmaceutical announced the discovery of an active substance that can promote liver cell regeneration, they were the first to notice the news.

But like most pharmaceutical companies, they were slightly shocked after seeing it, and then kept it in mind, preparing to wait for Qingshan Pharmaceutical to complete Phase II or even Phase III clinical trials before deciding whether to introduce the drug.

did not expect……

Novartis got there first.

John rubbed his temple 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 so courageous."

"You see, the time they applied for the new drug 'LivClearX' was almost the same as the time when Qingshan Pharmaceutical announced the discovery of the 'liver activator'...

In other words, they should have contacted Qingshan Pharmaceutical as soon as they heard the news and obtained the agency rights for this drug."

"Do they trust Qingshan Pharmaceutical so much? Aren't they afraid that this drug will not work and they will lose all 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 would never make such a radical choice."

"I guess this matter was probably pushed by their vice president Friedman."

"Friedman? The Jew?" Young John imagined what that man looked like.

"Yes."

Daniel nodded slightly, with an indescribable look on his face.

"This Jewish man has a PhD in both finance and biology and is very radical. He has promoted several overseas investments of Novartis in recent years."

"It's entirely possible that he would take that 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 luck!"

"From the current Phase II and Phase III clinical data of 'LivClearX', long-term use of this drug does have a good inhibitory effect on liver function abnormalities, inflammation and other problems caused by fatty liver. They are going to make a lot of money this time."

After the words fell, the two looked at each other and smiled bitterly.

In fact, Gilead has also been developing drugs for "fatty liver", but fatty liver is not a virus or an autoimmune disease. It is purely a problem caused by excessive fat accumulation, which makes it difficult to have an effective breakthrough.

Fortunately, because there has not been much progress, Gilead has not invested much in the research and development of fatty liver drugs.

But they knew very well,
Once this drug that can treat fatty liver disease comes to the market, it will undoubtedly end the situation where the entire medical community is helpless in dealing with fatty liver disease.

This will bring in a lot of money.

The two of them were sighing, and at this moment, young John suddenly reacted:

"Daniel, I found something interesting. Now 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."

“I didn’t know that it was Tsingshan Pharmaceutical that actually developed the technology.”

Daniel was slightly stunned and confused for a moment.

"Does it matter?"

Daniel actually doesn't care about this matter.

It is very normal to introduce drugs from pharmaceutical companies in other countries into the pharmaceutical industry, and most ordinary people will not care whether the drug is produced in the United States or Japan.

In fact, let alone the origin, most ordinary people don’t even pay much attention to the drug manufacturers.

Patients are more concerned about how effective this drug is.

"I don't know whether it's important or not, but I feel like the media and netizens are hyping up the new drug 'LivClearX' too much."

As he spoke, John took out his phone and quickly opened Twitter, then found some highly-rated replies in a message about a new drug called "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 one: '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 participated in the development of this drug. It is your dedication that makes me believe that America will be great again!'"

"Oh, Novartis, please bring this new fatty liver drug to everyone in the world, and let the technology of the USA shine on the world!"

"Yes, especially China, let them see that America is still great!"

Daniel's eyes widened as he looked at it. He snatched it from John's hand and kept looking at it. After a few minutes, he suddenly laughed, feeling a little evil.

"If these netizens knew the truth one day... they would probably collapse, right?"

"Haha, I'm wondering now if Novartis has noticed this problem."

……

Novartis has certainly noticed that as the Phase III clinical trial begins, more and more people on the Internet are touting LivClearX.

The wording even surprised Friedman.

Why didn't Novartis proactively state that this was a patented drug originating from China?

Which company would actively say in its advertisements that it is an agent for other people’s medicines?
will not.

Moreover, the drug itself has special properties, and patients are more concerned about the drug's effectiveness rather than which pharmaceutical company it is from.

Novartis headquarters, in the vice president's office.

"President Friedman, what should we do now?" "Although we have never actively promoted the fact that we developed 'LivClearX' ourselves, now both the media and ordinary netizens assume that this drug is developed by us..."

"Do you think we should issue a clarification announcement right now while the heat is still rising?"

Friedman remained silent as he listened to the public relations manager's report.

After a minute, he slowly looked away from the Twitter comments on the screen and rubbed his temple.

There are currently many comments on Twitter about the new drug "LivClearX". On the one hand, I did do 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!

As the third phase of clinical trials began, more than a dozen subjects took the initiative to post some medication records on Twitter, and everyone's enthusiasm was completely ignited.

For a time, praise and expectations for Novartis were overwhelming.

He is also very happy to see the good reputation created by this sentiment, which will undoubtedly have a great effect on the future sales and promotion of "LivClearX".

If it were suddenly clarified at this time that "LivClearX" was not developed by Novartis but by a Chinese pharmaceutical company, this would 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 this matter, I'll think about it."

"Okay, what if the president asks?"

"I will communicate with the president, don't worry."

……

While Friedman and the entire Novartis were still struggling with whether to take the initiative to clarify public opinion, Zhang Yang had already devoted himself to the Phase II clinical trial of "hepatocyte activator".

Since cirrhosis is a pathological change in the liver structure, countless liver cells have turned into hardened nodules that cover the entire liver.

Therefore, when the "liver activator" with a 70% effectiveness was put into phase II clinical trials, patients still did not show immediate and obvious therapeutic effects.

It was not until one and a half months after taking the medicine that the first batch of patients finally felt some obvious differences from before.

When Zhang Yang is free, 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 have an apple."

Zhang Yang did not call Liu Wenjun uncle just because he was 52 years old. He still called him by his name as before.

As a role model of the times, no one would think that Zhang Yang was impolite, and some even took it for granted.

"Mr. Zhang, you really flatter me. I feel embarrassed if you do it yourself."

"It's okay, just eat."

Zhang Yang smiled. He didn't care about these things. Every time he saw Liu Wenjun, he became more determined in his original intention.

That’s right, 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 the brink of death!

Instead of...cutting leeks!

"Liu Wenjun, how are you feeling recently? Are you feeling better?"

"much better."

Liu Wenjun smiled happily, took a bite of the apple, and said with emotion:
"Mr. Zhang, I have obviously felt a better appetite in the past week. Chinese medicine says that a good appetite will help blood flow smoothly. The liver stores blood, which means my liver blood circulation is much better than before."

"Besides that, I was always worried about my digestive tract bleeding, but after taking this medicine for the past two or three months, I haven't had any bleeding, and my stools are no longer black like before. 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 I asked this question deliberately was that I hoped Liu Wenjun could see his own changes and be more positive and optimistic about life.

"That's good! Don't worry, just focus on recuperating. You will get better day by day."

As he spoke, Zhang Yang stood up from his chair and patted Liu Wenjun on the shoulder.

"Then I'll leave first. I still need to talk to Director Chen Wen. I'll come see you next time."

"Okay, Mr. Zhang, take care. Haoran, you can see Mr. Zhang off."

Zhang Yang walked out of the ward at the polite words of Liu Wenjun's son Liu Haoran and then came to Director Chen Wen's office.

This is also one of his important tasks in the hospital.

Because all the patients in the clinical trial of "hepatocyte activator" are patients with cirrhosis, a large proportion of them are in the "decompensated stage", and these patients are already in danger of life at any time.

Therefore, a large number of subjects simply stayed in Chengdu Third People's Hospital and underwent clinical trials while being hospitalized.

This allows the Department of Hepatology to have more accurate clinical data for these patients.

"Mr. Zhang, you are here. Please take a seat."

Seeing Zhang Yang coming in, Chen Wen quickly stood up and brought a bench.

"You're welcome, I can do it myself."

Zhang Yang smiled slightly and sat down next to Chen Wen in front of the computer.

"It's the same as before. How are the clinical data you've been tracking in the past half month?"

"Very good, the effect can be seen in just half a month!"

Chen Wen clicked on a detailed data document, which contained all the data about the patients in various clinical trials.

He continued:

"There are a total of 98 subjects this time. Because it is a double-blind trial, we don't know which ones are in the experimental group and which ones are in the control group. But after one and a half months of continuous administration, there is gradually some effect. This week's data clearly shows the difference in the values ​​of some patients."

Zhang Yang looked slowly and found that it was exactly as Chen Wen said.

The levels of transaminase and alpha-fetoprotein began to decline significantly in some patients, and judging from the ultrasound diagnosis of the liver using imaging instruments, the elasticity of the liver also began to decrease slightly.

These data may seem insignificant at first glance, but the contrast is very obvious as batches of more than 30 people showed a downward trend, while the indicators of another 30 or 40 people remained unchanged.

This means that the drug has produced effects after long-term use by the subjects, and this is also the scientific aspect of clinical trials and double-blind tests.

"Okay, it seems that the current clinical data shows that it takes at least one and a half months of use to have a significant effect. 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 to see you in half a month."

After Zhang Yang saw the data, he prepared to leave, and Chen Wen also stood up to see Zhang Yang off.

But just as he reached the office door, Chen Wen suddenly remembered something and said:

"By the way, Mr. Zhang, I've noticed that many patients are discussing a drug recently. It's a drug from Novartis in the United States that also treats the liver."

"Look, do you know this medicine?"

As he spoke, Chen Wen took out his mobile phone and found the report on Novartis' new drug "LivClearX" on the official account.

(End of this chapter)