Chapter 138 Shenduqing officially launches clinical trials in China
“Pure, pee, hurry up!”
Professor Stephen felt more and more intense need to urinate, and he became more and more excited.
You know, he had not urinated for six months before this, and he had almost forgotten the refreshing feeling.
"The bathroom is over there! By the way, your urinal!"
In the waiting room of the clinical trial center, the patients on the side saw Stephen's anxious look and hurriedly reminded him.
“Thank you.”
Professor Stephen quickly came to the bathroom with a urinal. At this time, there were already several patients in the bathroom holding urinals and collecting urine. Seeing this, he couldn’t stop peeing. I couldn't help but walk to an empty partition and take off my pants.
"Shhh..."
A strong smell of ammonia hit his face, but Stephen didn't find it pungent, he only felt a sense of relief in his body for no reason!
It’s been a long, long time since he could excrete water and toxins through his urinary system so smoothly!
Cool!
100 times better than dialysis!
About thirty seconds later, the last drop of urine was put into the urinal. I picked it up and took a look at the scale, 900ML.
At this moment, he was completely convinced. The ability of the drug to restart the kidneys and the urinary system was very impressive.
The excited Professor Stephen returned to the clinical trial hall carrying a urinal filled with his own urine and went to the second window where he had just received the injection.
The "trouble" he felt just now is completely gone, and he is more excited and excited.
Not only him, but also a large group of subjects in front of the window holding urine and preparing to submit it to the nurse were extremely excited.
“It’s a miracle! I’ve been on dialysis for four years and three months, and I haven’t peeed for four years. I almost forgot what it feels like to urinate! I didn’t expect that I could urinate again. It’s enough. 800ML! ”
“Me too! I didn’t believe it before when people said that this ‘Kidney Clearing Dialysis Needle’ could restore urination. I didn’t expect that it would resume in just two hours. It’s amazing!”
"It's great! I didn't feel cherished when I urinated normally in the past. After the actual dialysis, I realized that being able to urinate normally is a luxury. Thank God, thank you for this drug that allows me to be a normal person again."
"Not only does it restore urination, the real core of this drug is to 'timely remove' toxins from the body, just like a built-in 'drug kidney'. I really hope that the effect of this drug can be further improved, if it can be improved to 80 %, 90% toxin removal rate Then it’s almost the same as a real kidney!”
“Huh...that’s right! Just now I thought the clinical trial process of this drug was too complicated. Now it seems that we must cooperate as much as possible. Provide more clinical data to the drug manufacturers!”
“That’s the truth, we must fully cooperate with the manufacturers!”
“By the way, I forgot the manufacturer of this drug again! What’s your name?”
"Qingshan Pharmaceutical, a pharmaceutical company from China."
"Okay, okay, cooperate, we must cooperate fully!"
The subjects who participated in the second phase of the clinical trial were "kidney poisoned" on the spot I am impressed by the powerful effect of "Clear Dialysis Needle".
However,
After two consecutive injections of "dialysis needles" and another necessary dialysis, everyone truly experienced the power and convenience of the "Kenduqing dialysis needle" at.
Too strong!
It used to require dialysis three times a week for four hours each time. Now you only need two injections of "Kidney Toxic Clear Dialysis Injection" to live a normal life!
And urinate in time to reduce the burden on the body!
After just two weeks of testing, all subjects found themselves becoming heavily dependent on the "Kidney Toxic Clear Dialysis Injection".
This dependence is not physical, but psychological.
After experiencing the ability to urinate normally and remove toxins immediately by injecting the "Kidney Toxin Clear Dialysis Injection", no one is willing to go back to the previous dialysis, and even the necessary weekly dialysis is somewhat rejected.
The news that the "Kidney Toxic Clear Dialysis Needle" can replace dialysis spread quickly in the American dialysis circle. Soon, nephrologists and people in the medical field across the United States also noticed the " Shenduqing dialysis replacement needle."
One week, two weeks, one month, two months;
With the progress of the second phase of clinical trials, the popularity of "Shenduqing" has not declined over time. On the contrary, with its excellent The stabilizing effect is becoming more and more popular in American dialysis circles, and attention is getting higher and higher.
While doctors are looking forward to it and patients are excitedly discussing when the "Kidney Toxin Clearing Dialysis Injection" will be on the market,
Near the end of the second clinical phase, Novartis suddenly announced the latest news from Qingshan Pharmaceutical:
In the third clinical phase, the effect of "Kidney Toxin Clearing Dialysis Replacement Injection" will be increased by 10% again, and the toxin clearance rate will be improved in the future. to an astonishing 80%!
The news was like a bombshell, instantly making the already highly anticipated "Kidney Toxic Clear Dialysis Replacement Injection" the focus of the dialysis circle again.
Mayo Clinic, Dialysis Center.
"Professor Stephen, will you continue to participate in phase III clinical trials?"
"Yes, of course we will! 80% of the toxin removal effect! In this way, it is almost comparable to a dialysis machine. We can almost reach a level close to that of human kidneys!"
"Exciting! I have to say that China’s Qingshan Pharmaceutical is really awesome, I really love them!”
“Haha, Who is not! I have become their loyal fan now!”
Of course Zhang Yang couldn’t hear the praise from the other side of the ocean. When the “Kidney Toxin Clearing Dialysis Injection” was about to complete the second phase of the FDA clinical trial, he According to the plan, the complete product with an effective clearance rate of 80% was provided to Novartis to facilitate its Phase III clinical trials.
In addition, 80% of the complete product has also been provided to GlaxoSmithKline, which is conducting phase III clinical trials in India.
The most important thing is that Zhang Yang is preparing to start clinical trials of the 80% complete product "Kidney Toxin Clearing Dialysis Injection" in China.
Because it is already a complete product, and "Shenduqing" has sufficient clinical phase I and phase II data in the FDA and India, this time, he plans to skip the clinical phase I and phase II, Directly try to apply for clinical phase III.
This is not something Zhang Yang came up with.
But it is due to the country’s continuous increase in support for the research and development of innovative drugs, especially in the past two or three months, several policies on “shortening the approval cycle of innovative drugs” have been introduced. One of them is to recognize the US FDA, the European Union and The results of clinical phase I and phase II trials passed by the UK.
However,
When Zhang Yang told Wei Tian his idea, Wei Tian was still a little hesitant.
“Boss, are you sure you want to directly apply for the third phase?”
“You know, although the policy has been introduced, it is a trial run. So far, there is still no pharmaceutical company in the country directly applying for it. There is a precedent for applying for clinical phase III..."
Zhang Yang smiled and waved his hand:
"It's okay. Since there is no such thing, we will set a precedent. The relevant departments have introduced such a policy, so we will You have to support it, don’t you?”
Tsingshan Pharmaceutical’s plan to directly apply for the third phase of clinical trials for “Kidney Clearing Dialysis Replacement Injection” soon came to the relevant offices of the State Food and Drug Administration.
That afternoon,
Chen Gang from the Drug Supervision Department urgently convened a discussion meeting with his direct leaders and technical staff.
"Wei Bureau, colleagues, the specific situation is this. Qingshan Pharmaceutical submitted a clinical trial application for the 'Kidney Clear Dialysis Replacement Injection', but what is completely different from before is that they applied to directly conduct clinical trials. Phase III trials, skipping clinical phases I and II ! ”
“Of course, they have also submitted the Phase I and II clinical data of this drug to the US FDA and India. I have seen it. The data is very complete and can be found on the official websites of FDA and India. , no problem.”
As he spoke, he finally said:
“Now, we need to finalize whether to allow Qingshan Pharmaceutical’s ‘Kidney Toxin Clearing Dialysis Injection’ to directly conduct Phase III clinical trials.”
After the words fell, Everyone in the conference room looked normal or a little excited.
Prior to this, China did not recognize the certification of FDA, EU and other markets. This resulted in some innovative drugs that even if they have been on the market for many years in other markets, they still need to start all over again if they want to be launched in China. The first clinical phase begins.
Although it has not been completely liberalized now, at the policy level, it can at least skip the first and second clinical phases, which undoubtedly saves pharmaceutical companies a lot of time and costs. After a while, a young technical backbone raised his hand and said:
“I think there is no problem. Since the country has issued relevant policies, as long as the conditions are met, we should naturally approve it and help pharmaceutical companies complete clinical trials quickly!”
With the first Personal remarks, soon a second one.
“I also agree. Although it has been three months since the release of the trial operation details and no pharmaceutical company has applied, we must take the first step. I think it is very good for Qingshan Pharmaceutical to take the lead!”
“Well, their data with the FDA is very complete, and I see no reason not to approve it!”
Everyone was talking to each other, and soon everyone's eyes fell on Bureau Wei, the direct leader above the conference room.
Director Wei Min nodded slightly and said simply:
"I have no objection. I also think that Qingshan Pharmaceutical has complete information and fully meets the requirements for skipping the first and second clinical phases."
“Furthermore, comrades, this is the first time in the history of clinical trial approval of Huaxia Medicine that we have accepted it with an open attitude. Accept and recognize the clinical data of the mainstream pharmaceutical market. ”
“Such a gesture will undoubtedly encourage more domestic pharmaceutical companies to go global. They will know that as long as the drugs are capable and effective, as long as the drugs pass clinical trials abroad. Test, the country also recognizes its data, they will no longer have to worry about it! ”
"This is definitely a historic moment in the history of Chinese medicine. This is definitely a huge progress in the history of Chinese medicine!"
Everyone nodded. Director Wei Min was right, but there was still something he didn't say.
The reason why the system can advance so quickly is because of Qingshan Pharmaceutical.
Suddenly, everyone thought of a sentence they often heard in meetings:
“We need to change our thinking now, not to let pharmaceutical companies like Qingshan Pharmaceutical adapt to our system, but to We should optimize the system to adapt to their development..."
I have to say, it’s great to be capable!
One week later.
Tsingshan Pharmaceutical’s application for “Kidney Clear Dialysis Replacement Injection” to skip the first and second clinical trials and directly conduct the third clinical phase in China was approved.
When the news was confirmed on the website of the State Food and Drug Administration, the entire domestic pharmaceutical industry was shocked.
Why did China not recognize overseas data from FDA and other markets before?
Racial differences, differences in ethical standards, and issues with the reliability of data sources are all reasons.
But the most important thing is:
Before this, there were not many domestic pharmaceutical companies that could sell domestically produced drugs overseas, and not many companies were willing to conduct clinical trials overseas... We know that the cost of clinical trials in the United States and Europe is significantly higher than that in China.
As a result, with few pharmaceutical companies and few drugs being tested overseas, what motivation do domestic regulatory agencies have to promote system reform?
Now, with Qingshan Pharmaceutical taking the lead, all relevant agencies have no choice but to take action.
Compared with the shock in the domestic pharmaceutical industry, domestic dialysis patients were finally overjoyed and rushed to tell each other.
After waiting for more than half a year, they also saw many reviews about "Kendu Qing" on the Internet. They couldn't wait to try it!
It’s fine now!
Qingshan Pharmaceutical’s “Kidney Toxin Clearing Dialysis Replacement Injection” is finally about to launch clinical trials in China.
Because this time it was a phase III clinical trial with a total recruitment task of 500 people, Zhang Yang still placed the main trial hospital in Chengdu Third People's Hospital.
Of course, he did not forget that Dean Gan of West China had recommended him to attend the "Global Kidney Summit".
In return, 150 of the 500 people were allocated to West China Hospital.
Two days later, the third phase of clinical recruitment for Qingshan Pharmaceutical’s “Kidney Toxin Clear Dialysis Replacement Injection” officially began. At this moment, another piece of news came that made Zhang Yang even more concerned.
Independently developed by the German BI company, the "BI-toxin filtration catalyst" that can be used to improve the toxin removal rate in hemodialysis has completed the first phase of clinical trials, and a large number of clinical results have been published online.
After hearing the news, Zhang Yang immediately came to the drug research and development center. He wanted to see for himself the effects of the first clinical phase data of "BI-Toxin Filtration Catalyst".
An hour later, he frowned and looked at Wei Tian aside.
“Judging from the clinical data results alone, this drug clearly did not meet BI’s design expectations.”
“Only 2 of the 20 clinical phase I data showed an increase of 3.5%. blood toxin clearance, remaining The improvement of 14 servings was only 2%, and the remaining 4 servings had no effect on improving the toxin removal rate.”
“This is far from the 7% they expected.”
Wei Tian snorted and exhaled softly.
Zhang Yang has always asked him to pay attention to the developments of BI Company's drug at all times, and he is naturally very familiar with this drug.
“Boss, that’s indeed the case.”
“And, I have gradually begun to feel less optimistic about the business prospects of their catalyst.”
“Yes. ?”
Zhang Yang was stunned for a moment, then said:
"Tell me what you think."
"Because you asked me to pay special attention to the development progress of this drug, I also paid special attention to it."
"This drug is mainly used for In order to improve the effective toxin filtration rate of dialysis patients, the removal efficiency of dialysis machines is now about 85%. The cost of each ordinary dialysis in China is about At 1,000-1,200 yuan;
If this medicine can only increase by 2-3%, I think it is difficult for any hospital or patient to choose it.”
“After all, adding more medicine is the same. The cost of treatment has increased...I guess the BI company is also quite disappointed with this result!”
Zhang Yang nodded slightly, 2-3% was indeed a bit low.
After a while, he said to himself:
"Wei Tian, do you think they have a chance to increase it to 7% after subsequent improvements?"
" I don’t know.”
Wei Tian shook his head honestly.
As a non-core member of the drug, it is simply unrealistic to definitely confirm the follow-up status of the drug.
But after a moment, his eyes lit up:
“Boss, I don’t know, but there is someone who should have some clues.”
“Who?”
"The person who will join us soon is Fang Hanliang, the former top drug researcher at BI Company."
"Fang Hanliang?"
"Well, he should know!"
There are many people and many things to do during the National Day. There have been a few updates in the past two days. Everything will return to normal when I start working tomorrow. , thank you for your understanding
(End of this chapter)