Chapter 110 Surprise! Giant Novartis has developed a specific drug for fatty liver! (Additional update for the dust blown away by the wind 0)
Zhang Yang ultimately rejected Friedman’s strategy.
From beginning to end, his original intention in developing this "hepatocyte activator" was to save the fate of a generation and save the fate of patients who became cirrhotic due to hepatitis B.
For example, Liu Wenjun from 12 to 52 years old.
If the "liver activator" has only 50% therapeutic effect, it will be just like the results of the first phase of clinical trials. It may be barely maintained but it will never be reversed. Countless cirrhosis patients will still be dying. on-line.
After all, cirrhosis is not fatty liver.
However.
Friedman’s words still moved Zhang Yang’s heart.
There are already more than 120 million patients with fatty liver in China. The current 50% activator sample can indeed relieve and protect the liver. There is no reason not to earn this money.
He began to think about whether to re-establish the project, or simply let 50% of the samples become health products, so that patients with fatty liver disease could buy them themselves.
In this way, the complete "hepatocellular activator" can be classified as a drug, and the 50% effective "hepatocellular activator" can be classified as a health product, thus distinguishing the two.
“Hey, it’s still corroded!”
Zhang Yang sighed and made a mental note of this matter. Next, he had to carefully understand the declaration and approval of health care products.
And the other side.
After getting permission from Zhang Yang to re-sign the agreement, Friedman immediately flew back to the United States to start recruiting Phase II clinical patients.
This time, there were only 98 people in their second phase of clinical trials, and Novartis recruited enough patients in just one week.
Of course, almost all of the 98 patients were patients with severe fatty liver and cirrhosis caused by fatty liver, and the "Liver Cell Regeneration Activator" project was also renamed "Fatty Liver Activator";
At the same time, the treatment direction was adjusted from the previous "cirrhosis and fatty liver" to "fatty liver and cirrhosis".
Everything was going smoothly, and before I knew it, Novartis was making significantly faster progress with the FDA than Tsingshan Pharmaceutical.
About another month later, Tsingshan Pharmaceutical’s “liver-stimulating activator” finally passed the domestic clinical phase II approval and can officially start phase II clinical trials.
Tsingshan Pharmaceutical's clinical phase II design plan is for a three-month period, with a total of 94 subjects with cirrhosis.
Different from Novartis's clinical phase II, Novartis mainly targets patients with severe fatty liver disease, while Tsingshan Pharmaceuticals deals with cirrhosis, 90% of which are caused by hepatitis B.
This makes both parties The clinical trials officially started here and there is a huge difference. One is prone to fatty liver and the other is prone to cirrhosis.
Tsingshan Pharmaceutical has just begun to recruit subjects, but Novartis’ clinical phase II has already started progressing. The first month’s clinical data of the first batch of 20 subjects has been released.
Immediately afterwards, the clinical data of more than 80 people in the second, third, and fourth batches were also collected.
Seeing the data, Novartis executives breathed a sigh of relief. After expanding the number of subjects in the second clinical phase, the clinical treatment effect is still very stable. Subtle changes have begun to appear in the experimental group and the control group, and this change will continue as the Taking medication is becoming more and more obvious!
Sure enough.
When the second month’s data results are calculated, a clear gap can be seen between the performance of the two months and the two data.
The transaminases in the test group decreased slowly, liver inflammation indicators improved significantly, and liver elasticity began to return to normal values.
With a large amount of clinical data and the analysis of the drug ingredients of "Hepatocellular Activator" in Novartis laboratories, Novartis executives from the president to the head of the R&D center have almost confirmed that this drug has passed clinical trials. The probability of listing in the third phase is almost 99%!
"President Green, in half a month we will successfully complete the second phase of clinical trials."
"There are no repeated modifications of ingredients and no repeated changes in dosage. In addition, our drugs are mainly targeted at fatty liver disease." Patients, I think we can start the third phase of clinical trials soon or even launch it quickly."
"I suggest that we can publicize it to the outside world, medical journals, Biology professors and the media can start publicity and reporting!”
“There are 50 million severe fatty livers in our country, and there are countless ordinary fatty livers. Once the news is reported, it will definitely attract everyone’s attention. The follow-up sales were also very helpful to us!”
Friedman’s proposal was quickly approved by President Green.
Three days later, a piece of news about a drug developed by Novartis that can treat "fatty liver" appeared in a medical journal. After being reprinted by many media,
"Hepatocyte Activator" in the United States The new name "LivClearX" appeared in the public eye for the first time.
“LivClearX! Liv is the abbreviation of Liver, Clear means clearing, clearing liver toxins, what a good name!”
“The medicinal ingredient in LivClearX is a very effective treatment for fatty liver. Active enzymes with good therapeutic effects can effectively relieve liver inflammation and restore the liver to health..."
"Long-term use can accelerate the decomposition of fat in the liver and reduce the risk of cirrhosis and liver cancer!"
"Oh, mygod, is this true? This is definitely the best news I have heard this year!"
"Really, of course it is true. I have also confirmed it on the FDA website. The drug 'LivClearX' applied by Novartis has completed the second phase of clinical trials, and the clinical data has performed very well!"
"Really? Damn it, I just found out now that I’m already 300 pounds, and the doctor said my liver is already full of fat, and I won’t be able to save it if I don’t lose weight! When will this drug be available?”
Recommendation There has been a lot of discussion about Novartis' new drug "LivClearX", and Anderson, a 20-year-old who has been testing the drug for a long time, also saw the news. He hurriedly posted the hottest reports to the "drug trial group" and then @his friend James.
"James! Don't you suspect that the medicine I'm taking is ineffective? Look, there are now reports on this medicine in the New England Journal of Medicine! It can protect the liver and even break down fat. Did you see it?!"
"I see, Shit! The results of the second clinical phase are really effective. Can you tell me how it really feels?"
"Excellent! The first clinical phase I have been taking it for two months, and now I am in the trial group of the second phase of the clinical trial. I have been taking it for 4 months! My transaminase will be normal soon, and I feel like my liver has been reborn.”
"They are about to start the third phase of clinical trials, and I will continue to sign up for trials!"
"Oh, Anderson, will you spend money to buy it after the third phase of clinical trials is completed and launched?"
"Yes! Of course I will! I will take it every day just like you eat chocolate, and now you can guess how much a box will cost."
"Haha, Anderson, I guess you can't afford it!"
“Fuck!”
Anderson is indeed becoming more and more fond of this drug for treating fatty liver, and he has already made plans to continue participating in phase III clinical trials.
Even if there is no pay for the third clinical phase, he will still participate.
Gradually, as Novartis began to carry out advertising, and many subjects also posted some trial results on the Internet, the reputation and information of the new drug "LivClearX" also spread little by little.
Zhang Xiaohua is a medical student and has his own medical-related public account.
With his excellent English skills, he often transfers the research and development progress of some popular foreign drugs to the public account.
On this day, he accidentally discovered the new drug "LivClearX".
“A new drug that can effectively relieve liver inflammation and have excellent therapeutic effects on fatty liver?”
"At the same time, long-term use can prevent the further development of cirrhosis, purify the liver microenvironment, and reduce the risk of cirrhosis and liver cancer!"
"R&D company - Novartis!"
"Holy crap! Novartis silently releases new drug! We must move back to China. There are so many patients with fatty liver and cirrhosis in China. Now there is hope for the patients.”
Zhang Xiaohua compiled and translated the information from the external website overnight. In the early morning of that day, he was in his own room! The public account posted this news.
【Latest news! Pharmaceutical giant Novartis has developed a drug that can treat fatty liver and cirrhosis! 】
Early the next morning,
this article immediately attracted the attention of a medical media and immediately reprinted it. In the afternoon of the same day, it attracted a small amount of attention in the medical circle.
Many medical professionals began to inquire about the authenticity of the news, and many people began to discuss it.
Everyone remembers clearly that about half a year ago, Tsingshan Pharmaceutical announced that it had found an activator that could effectively regenerate liver cells.
It seems that their new drug has just started the second phase of clinical trials, right?
But Novartis has already publicized it to the outside world, and seems to be preparing for Phase III clinical trials and then launching it on the market!
Hey guys, Qingshan Pharmaceutical is going to be banned? !
The discussion is getting louder. On the other side, I have to say that Novartis is indeed a well-known global giant.
With the name of Novartis and keywords such as "cirrhosis" and "fatty liver", the article was quickly forwarded to Moments, WeChat groups, and patient groups.
Among them, the liver cirrhosis patient group of Chengdu Third People’s Hospital also received several forwards from patients.
In fact, the vast majority of patients in the group have only joined in the past two or three months. They all transferred here after seeing that Qingshan Pharmaceutical began to conduct clinical trials of "hepatocyte activator" here, hoping to If you get ranked, you can use new medicines.
But the clinical effect of the first clinical phase of "Activating Agent for Promoting Liver Cell Regeneration" is indeed not very obvious, and the evaluation of patients participating in the trial is also very average. It is different from the previous "ITG Myelin" and "Ai Compared with "Beprofovir", its reputation is much worse.
This makes many patients who have high hopes for Qingshan Pharmaceutical feel a little disappointed.
The second clinical phase of the "hepatocellular activator" only recruited 94 people, and the vast majority of patients did not get a quota.
The news of Novartis' new drug "LivClearX" suddenly caused domestic dissatisfaction Patients with cirrhosis are less concerned.
...
PS: 0 additional updates for the dust blown away by the wind. There are 4 chapters left after tipping and updating.
(End of this chapter)