After being fired, I became the light of medicine

Chapter 126 Lucas, you are not talking about India, are you?
“If they don’t get sick, how can we make money from our medicine?”

Hearing Friedman say this, Zhang Yang suddenly felt a chill.

The wind along the Huangpu River was cool, but not as cool as Friedman's words.

A long time ago, he had accidentally heard that in addition to the military-industrial complex, there was another consortium in the United States, that is, the medical complex.

Although this complex is not as powerful as the military-industrial complex and the oil complex, it firmly controls the ordinary people of nearly 2 million Americans.

You can go your whole life without buying an AK or going to a shooting range; you can also go your whole life without buying a car or burning oil, but you will get sick all your life, right?
When you think about the high blood pressure and diabetes rates per capita in the United States today, it’s hard not to think of Fei Fei.

At this moment, Lucas on the side seemed to be unable to bear Friedman's words and retorted:
"Friedman, your Novartis is an international pharmaceutical company with a history of hundreds of years. I believe that the original intention of all pharmaceutical companies is to relieve patients' pain, not just to make money."

"You've made our work sound too dirty and too fame-seeking. I can say for sure that at least we at GlaxoSmithKline don't have the same idea 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 argue with you."

"Zhang, let's get back to the topic we were talking about. Our country has the second largest kidney disease market in the world, so we really need your 'Kidney Toxin Clearing Alternative Injection';
We can do the same as last time with 'LivClearX', where you conduct clinical trials in China and we simultaneously apply for FDA certification in the United States."

"What do you think?"

Zhang Yang's thoughts were also brought back to the main business. He was indeed not opposed to cooperating with Novartis. After all, with the experience of the last cooperation with "LivClearX", from the perspective of making money, Novartis was still a trustworthy partner.

but,

He recalled the problems Wei Tian had reported before regarding the clinical trials of the "Kidney Toxin Clearing Replacement Injection".

Because the initial "kidney toxin removal replacement injection" only has a clearance efficiency of 60%, it means that 40% of the toxins in the subject's body cannot be excreted.

In this case, the subject needs to persist for 4-5 days before undergoing dialysis again.

40% of toxins in the body is roughly a state of renal failure. The patient will feel obviously unwell, and this state must continue for three months of clinical trials. For the subjects, there is a great risk of toxins invading organs and causing organ failure, as well as unknown risks.

and so.

Even if the "Kidney Du Clearing Dialysis Replacement Injection" has passed the approval of the domestic ethics review committee, in addition to labeling the risks and repeatedly informing the subjects like the previous "Ekofovir", it is also necessary to continue to monitor the patient's condition every day.
Patients must be forced to withdraw from the trial if they feel the slightest discomfort, out of fear of death.

This is also the reason why Zhang Yang has been hesitating whether to start the Phase I clinical trial. After all, the lives of the subjects are also lives!
Thinking of this, he slightly organized his words and said:

"Friedman, I also hope to reach a cooperation with Novartis again, but..."

"Do you remember what I said at the meeting this afternoon about the current troubles?"

"The problem is not because of anything else, but because the current 'dialysis needle' with an effective clearance rate of 60% is likely to cause unavoidable damage to the subjects during clinical trials, or even death."

"Death?" Friedman looked at Zhang Yang curiously.

"That's right..."

Zhang Yang did not hide anything and immediately informed Friedman of the Ethics Committee's assessment report:

"We found an ethics committee to evaluate the safety. 40% of the residual toxins were in the subjects, which is about the same as the residual toxins in patients with renal failure. As you know, many people will experience edema, nausea, and vomiting in the renal failure stage, and they will already need dialysis at this time."

"However, in order to complete the clinical trial data collection, they have to endure this condition for 4-5 days, which may cause toxins to invade organs and eventually lead to failure and death."

"Of course, the biggest possibility is that it will cause unavoidable organ damage."

“That’s what we’re worried about.”

"Oh."

Friedman nodded thoughtfully, and after about two seconds, he looked back at Zhang Yang.

"Zhang, I thought you were worried about something, but it turns out you were worried about this..."

"But I think you're being too cautious."

Zhang Yang was slightly stunned:
"Am I too cautious?"

"Yes."

"Like you just said, 40% of the toxins remaining are roughly the amount of toxins in the human body during renal failure. This amount of toxins is unlikely to kill a person, but it will only cause serious damage to the organs, especially the heart."

"In other words, even if a test subject dies suddenly due to organ failure, it's not a big deal. What does it matter if a few Americans die on the road to developing new drugs?"

Zhang Yang was stunned. What does it matter if a few Americans die? !

At this moment, Friedman smiled brightly and said in a relaxed tone:

"Zhang, don't worry. Many things are not as serious as you think. Every year, hundreds of people die in the FDA due to new drug trials. It's nothing new."

"As long as you are willing to give us the agency rights for this drug in North America, I can assure you that this drug will definitely pass FDA approval smoothly."

"At the same time, we can also do as we did in the last 'LivClearX' cooperation, where we pay 80% of the clinical trial costs and you pay 20%."

A breeze blew over the Huangpu River, and Zhang Yang exhaled heavily. He laughed at his own knowledge. He never expected that the unknown risks that he valued so much would be so lightly described by Friedman.

Aren’t the lives of the lower-class people in the United States real lives?

But before he could worry about the Americans, he suddenly became excited.

"I almost forgot one thing. If the 'Kidney Toxin Clearing Dialysis Needle' is undergoing clinical trials at the FDA, then there is no need for me to conduct simultaneous clinical trials in China!"

"We just need to wait for the clinical trial in the United States to gradually improve the 60% clearance effect to 80%. After passing the FDA clinical certification, we can return to China and directly apply for the Phase III clinical trial, right?"

"In this way, domestic patients will at least not have to bear the risks brought by 60% of semi-finished products!"

Thinking of this, Zhang Yang breathed a sigh of relief. It was definitely the best way to let the Americans and the FDA certify it first, and then upgrade the "Kidney Toxin Clearing Dialysis Needle" to a complete product directly in the United States!

After a moment, he no longer hesitated and nodded:

“Friedman, I am also looking forward to working with Novartis. I think we can work together again on this matter!”

"That's great!"

Friedman's face lit up with joy. At this moment, Lucas on the side became a little anxious.

The reason why he came to Zhang Yang today was naturally because of the "Kidney Toxin Clearing Dialysis Needle" matter.

Not to mention that GlaxoSmithKline was somewhat jealous of the huge profits brought by Novartis' agency of "LivClearX", but its previous cooperation with Tsingshan Pharmaceutical as the agent of "ITG Human Myelopoietin" also brought it a huge profit.

After tasting the sweetness, they naturally have a strong interest in continuing to be the agent for Qingshan Pharmaceutical's drugs.

Seeing that Friedman had already negotiated the US market agency, he said anxiously:

"Zhang, to be honest, after I heard about this drug at the summit this afternoon, we also want to be the agent for this drug."

Zhang Yang was of course aware of Lucas's thoughts, but after hearing Friedman's explanation of the US kidney disease market, he couldn't help but ask curiously:

"Lucas, is the incidence of kidney disease also high in the UK?"

Lucas was stunned for a moment, then smiled awkwardly.

"No, we don't have many kidney disease patients in the UK..."

After saying that, he pondered for two seconds, looked at Friedman again, and seemed to have made up his mind.

"So... this time we want to get the agency rights for this drug in the entire European region. There aren't 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 say anything, Friedman stopped in surprise:

"Lucas, you have quite a big appetite. You have left the EU but 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. If you want to sell drugs in the EU, you must undergo EU clinical trial certification!"

"Some of the EU clinical trial certification terms are even stricter than those of the FDA. According to the drug risks you just mentioned, it is very likely to be marked as 'high risk' under the EU clinical trial system!"

“Once they are labeled as ‘high risk’, it is very likely that they will not be able to recruit enough patients for several years…”

Zhang Yang originally thought that Friedman was just deliberately exaggerating to sow discord between him and Lucas, but he didn't expect that after he finished speaking, Lucas nodded and simply admitted:

“That’s right. If the risks Zhang mentioned just now were directly tested in the EU, they would most likely be labeled as high-risk, and it would be difficult to recruit enough subjects!”

"But Friedman, don't forget that in addition to the EU and the UK, we have another place to conduct clinical trials, and the results obtained there will still be recognized by our British Medicines and Drug Administration!"

"That place is also a country with a high incidence of kidney disease. There is no shortage of kidney disease subjects there. At the same time, they are of the Asian race just like China!"

Friedman suddenly opened his mouth wide; he had forgotten about this.

Zhang Yang was a little confused, but after thinking about the Asian race and the fact that "it will still be approved by the British Medicines and Healthcare Products Regulatory Agency", he suddenly understood.

He looked at Lucas.

"Lucas, you don't mean India?"

Lucas smiled slightly, then nodded heavily.

"Yes, it is India. It 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: -1 extra chapter for the first order owed, and there are two chapters left.

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(End of this chapter)