Chapter 126 Lucas, you’re not talking about India, are you (please subscribe for more updates)
“If they don’t get sick, how can our medicine make money?”
Listen Fried When Man said this, Zhang Yang suddenly felt a chill on his body.
The wind by the Huangpu River is cool, but it is not as cool as Friedman's words.
A long time ago, he accidentally heard that in addition to the military-industrial complex, there is another consortium in the United States, and that is the pharmaceutical complex.
Although this complex is not as powerful as the military-industrial complex and the oil complex, it firmly controls the ordinary class of nearly 200 million people in the United States.
You can never buy an AK or go to a shooting range for the rest of your life; you can also never buy a car or burn gas, but you will always get sick, right?
Thinking about the average per capita hypertension and diabetes in American society today, it is hard not to think of Feifei.
At this moment, Lucas on the side seemed unable to bear Friedman’s words and retorted:
“Friedman, you Novartis have been a family for hundreds of years. International pharmaceutical companies, I believe that the original intention of all pharmaceutical companies is to relieve patients' pain, not just to make money. ”
"You said that the work we do is too dirty and too prestigious. I can say with certainty that at least we at GlaxoSmithKline don't have such thoughts as you."
Friedman shrugged and didn't care. After a moment, he looked at Zhang Yang and brought the topic back on track.
“Okay, I don’t want to have a verbal dispute with you.”
“Zhang, let’s go back to the topic just now. Our country has the second largest kidney disease market in the world, so it’s very important. We need your 'Shenduqing Replacement Injection';
We can do the same as the last time for 'LivClearX', you conduct clinical trials in China, and we apply for FDA certification in the United States simultaneously. ”
"What do you think?"
Zhang Yang's thoughts were also brought back to business. He did not resist cooperation with Novartis. After all, he had the experience of the last cooperation with "LivClearX". From the perspective of making money Therefore, Novartis is still a trustworthy partner.
However,
he remembered what Wei Tian had reported before about the problems encountered in the clinical trial of "Shen Duqing Replacement Injection".
Because the initial "Kidney Toxin Replacement Injection" only has a 60% clearance efficiency, which means that 40% of the toxins in the subject's body cannot be excreted.
In this case, subjects need to persist for 4-5 days before receiving dialysis again.
40% of toxins in the body are approximately the state of renal failure. The patient will feel obviously uncomfortable, and this state will last for three months in clinical trials, which is extremely toxic to the subjects. The risk of organ failure caused by invasion of organs, as well as unknown unknown risks.
So.
Even if the "Kidoxin Dialysis Replacement Injection" is approved by the domestic ethics review committee, in addition to the need to label the risks and repeatedly inform the subjects like the previous "Ecofovir", it also needs to continue to monitor the risks every day. The patient's condition is monitored,
the patient must be forcibly withdrawn from the trial if they feel the slightest discomfort. The purpose is to fear death.
This is also the reason why Zhang Yang has been hesitant to start the first phase of clinical trials. After all, the lives of the subjects are also life!
Thinking of this, he sorted out his language a little and said:
"Friedman, I also hope to cooperate with Novartis again, but..."
"Do you remember what I said at the meeting this afternoon that we are currently encountering a little trouble?"
"This trouble is not other, but because the current 'dialysis needle' with an effective clearance rate of 60% is in clinical trials. It is very likely to cause inevitable damage to the subject, or even death.”
"Death?" Friedman looked at Zhang Yang curiously.
"Yes..."
Zhang Yang did not hide anything, and immediately informed Friedman of the ethics committee's evaluation report:
"We found the ethics committee After evaluating the safety, 40% of the residual toxins were in the subjects' bodies, which is approximately the residual toxins in patients with renal failure. You know, when kidney failure occurs, many people will develop edema, nausea, and vomiting, and will already need dialysis.”
“But in order to complete the collection of clinical trial data, they must endure this situation4- 5 days, this may cause toxins to invade the organs and eventually lead to failure and death.”
"Of course, the biggest possibility is inevitable organ damage."
"This is also what we are worried about."
"Oh."
Friedman He nodded thoughtfully, and about two seconds later, he looked at Zhang Yang again.
"Zhang, I thought you were worried about something, but it turned out that you were worried about this..."
"But I think you are too cautious."
Zhang Yang was slightly startled:
"Am I too cautious?"
"That's right."
"As you just said, 40% of the toxin residue is about the toxin content in the human body during renal failure. This toxin will most likely not kill people. It will only cause serious damage to the organs, especially the heart."
"In other words, even if a subject does die suddenly due to organ failure, it is not a big problem. How many Americans die on the way to develop new drugs?"
Zhang Yang was stunned, how many died? Who are Americans? !
At this moment, a bright smile appeared on Friedman's face, and he said in a relaxed tone:
"Zhang, don't worry, many things are not as serious as you think, FDA It is common for hundreds of people to die every year due to new drug trials.”
“As long as you are willing to hand over the agency rights of this drug in North America, I can assure you that this drug will definitely go smoothly. Passed FDA certification ”
"At the same time, we can also do like the last 'LivClearX' cooperation, where we pay 80% of the clinical trial costs and you pay 20%."
The breeze blew by the Huangpu River, and the publicity was heavy. Exhaling a breath, he laughed a little at his own knowledge. I really didn’t expect that the unknown risks that I took seriously in my eyes would be so downplayed in Friedman’s eyes.
Isn’t the life of the lower class people in America not life?
But before he could worry about the Americans, he suddenly became excited.
"I almost forgot one thing. If the 'Kidney Clearing Dialysis Injection' undergoes clinical trials at the FDA, then there is no need for me to conduct simultaneous clinical trials in China!"
"I just need to wait for it to be carried out in the United States. During the clinical trial, the 60% removal effect was gradually improved to 80%. After passing the FDA's clinical certification, we can return to China and apply directly. Isn’t it enough to be in the third phase of clinical trials?”
“In this way, domestic patients at least don’t have to bear the risks of 60% of the semi-finished products!”
Thinking of this, Zhang Yang felt relieved! In one breath, let the Americans and FDA certify it first, and directly upgrade the "Kidney Toxin Clearing Dialysis Injection" to a complete product in the United States. This is definitely the best way!
After a moment, he no longer hesitated, nodded and said:
"Friedman, I'm also looking forward to cooperating with Novartis. I think we can work together again on this matter!"
"That's great!"
Friedman's face brightened. Hi, at this moment, Lucas on the side became a little anxious.
Of course he came to Zhang Yang specifically for the "Kidney Toxin Clearing Dialysis Injection" today.
Not to mention being jealous of the huge profits brought by Novartis's agency "LivClearX", the previous cooperation with Tsingshan Pharmaceuticals to distribute "ITG human myelopoietin" also gave GlaxoSmithKline a huge sum of money. profit.
After tasting the sweetness, he naturally has a strong interest in continuing to represent Qingshan Pharmaceutical's drugs.
Seeing that Friedman had already negotiated an agent for the US market, he said anxiously:
“Zhang, to tell you the truth, after I heard about this drug at the summit this afternoon, We also want to represent this drug.”
Of course Zhang Yang also knew what Lucas was thinking, but after what Friedman just said about the US kidney disease market, he couldn’t help but curiously asked:
"Lucas, do you also have a high incidence of kidney disease in the UK?"
Lucas was stunned for a moment, then smiled awkwardly.
"That's not true. We don't have many kidney disease patients in the UK..."
After saying that, he thought for two seconds, then looked at Friedman, and seemed to have made up his mind.
“So... this time we want to win the agency rights of this drug throughout Europe. There are indeed not many kidney patients in the UK, but if we include the whole of Europe, there will be a lot of kidney disease and dialysis patients. ! ”
“All of Europe?”
Before Zhang Yang could speak, Friedman stopped in surprise:
"Lucas, your appetite is really big. You have already left the EU and you are still thinking about the whole of Europe!"
>
After saying that, he turned to look at Zhang Yang:
“Zhang, you may not know the EU’s drug marketing rules. To sell drugs within the EU, you must carry out EU clinical trial certification!”
“Some terms of EU clinical trial certification are even more stringent than the FDA. According to the drug risks you just mentioned, in It is very likely to be labeled 'high risk' under the EU's clinical trial system ”
"Once labeled as 'high risk', it is very likely that we will not be able to recruit enough patients for several years..."
Zhang Yang originally thought that Friedman was just deliberately alarmist to provoke his cooperation with Lucas. Unexpectedly, Lucas nodded and admitted simply:
"Yes, if the risks Zhang mentioned just now are tested directly in the EU, it is very likely that they will be labeled as high risks. It’s difficult to recruit enough subjects!”
“But Friedman, don’t forget, besides the EU, besides the UK, there is another place where we can conduct clinical trials, and the results obtained there will still be the same. Recognized by our British Medicines Agency!”
“That place is also a big country with kidney disease, and there is no shortage of kidney disease subjects there. At the same time, it is also of Asian race like China!”
Friedman suddenly opened his mouth. He forgot about this.
Zhang Yang was a little confused when he heard this, but after thinking about the Asian race and thinking that "it will still be recognized by the British Medicines Agency", he suddenly understood.
He looked at Lucas.
"Lucas, you don't mean India, do you?"
Lucas smiled slightly, and then nodded heavily.
“Yes, it is India, which is the world’s largest generic drug production base, but what many people don’t know is that it is also the world’s largest clinical trial base.”
……
PS : The first order I owe is -1 plus, and there are still two chapters left.
It’s the end of the month, everyone who has a monthly vote should vote!
(End of this chapter)