After being fired, I became the light of medicine

Chapter 138 Shenduqing officially launched clinical trials in the country

"Catch the urine, catch the urine, catch the urine quickly!"

Professor Stephen felt the urge to urinate more and more, and became more and more excited.

You know, he hadn't urinated for six months before this, and he almost forgot the feeling of exhilarating urine.

"The bathroom is over there! Oh, and your urinal!"

In the waiting room of the clinical trial center, a fellow patient saw Stephen's anxious look and hurriedly reminded him.

"Thank you."

Professor Stephen hurried to the bathroom with a urinal. At that time, there were already several patients in the bathroom using urinals to collect urine. Seeing this, he could no longer bear it and walked to an empty partition room to take off his pants.

"Shh..."

A strong smell of ammonia hit Stephen in the face, but he didn't find it pungent. He just felt an inexplicable sense of comfort in his body!
It had been a long time since he had been able to excrete water and toxins so freely through his urinary system!
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 looked at the scale: 900ML.

At this moment, he was completely convinced. The ability of this drug to restart the kidneys and reactivate the urinary system was extremely amazing.

Excited Professor Stephen returned to the clinical trial hall carrying a urinal filled with his own urine and came to window number two where he had just received the injection of the drug.

He no longer had the "trouble" he had just felt, and was instead filled with more excitement and excitement.

Not only him, but a large group of subjects in front of the window who were holding urine and preparing to hand it over to the nurse were extremely excited.

"It's a miracle! I've been on dialysis for four years and three months. I haven't urinated for four years. I almost forgot what it felt like to urinate! I didn't expect that I could urinate again, a full 800ml!"

"Me too! I didn't believe it when someone told me that this 'Kidney Toxin Clearing Dialysis Needle' could restore urination. I didn't expect that I could restore urination in just two hours. It's amazing!"

"It feels great! I didn't appreciate the fact that I could urinate normally before. It was only after I started dialysis that I realized that being able to urinate normally was a luxury. Thank God, thank you for this drug that allows me to be a normal person again."

"Not only does this drug restore urination, the real core of this drug is to 'clear' toxins from the body in a timely manner, just like a built-in 'drug kidney'. I really hope that the effect of this drug can be further improved. If the toxin clearance rate can be increased to 80% or 90%, it will be almost the same as a real kidney!"

"Huh... That's right! Just now I thought the clinical trial process for this drug was too complicated. Now it seems that we must cooperate well and provide as much clinical data as possible to the drug manufacturer!"

"That's why we must fully cooperate with manufacturers!"

"By the way, I forgot the name of the manufacturer of this drug."

"Qingshan Pharmaceutical, a pharmaceutical company from China."

"Okay, okay, cooperate. I will definitely cooperate with you to the best of my ability!"

The subjects who participated in the Phase II clinical trial were immediately impressed by the powerful effect of the "Kidney Toxin Clearing Dialysis Needle".

but,

After two consecutive injections of the "dialysis needle" and a necessary dialysis, everyone truly experienced the power and convenience of the "Kidney Toxin Clearing Dialysis Needle".

too strong!
Patients who used to need dialysis three times a week, each session lasting four hours, can now lead a normal life with just two injections of “Kidney Toxin Clearing Dialysis Needles”!
And it is better to urinate in time to reduce the burden on the body!
After just two weeks of the trial, all the subjects found themselves becoming seriously dependent on the "Kidney Toxin Clearing Dialysis Needle".

This dependence is not physical, but psychological.

After experiencing the experience of being able to urinate normally and remove toxins immediately after being injected with the "Kidney Toxin Clearing Dialysis Needle", no one is willing to go back to the previous dialysis, and even some are averse to the mandatory dialysis once a week.

The news that the "Kidney Toxin Clearing Dialysis Needle" can replace dialysis spread quickly in the American dialysis circle. Soon, nephrologists and medical professionals across the country also noticed the "Kidney Toxin Clearing Dialysis Replacement Needle" that was undergoing phase II clinical trials.

One week, two weeks, one month, two months;
As the Phase II clinical trial progresses, the popularity of "Shenduqing" has not decreased over time. On the contrary, it has become increasingly popular in the U.S. dialysis circle due to its excellent and stable effects, and has received increasing attention.

While doctors were looking forward to it and patients were excitedly discussing when the "Kidney Toxin Clearing Dialysis Needle" would be available on the market,
As the Phase II clinical trial was about to end, Novartis suddenly announced the latest news from Tsingshan Pharmaceutical:
In the third phase of clinical trials, the effect of the "Kidney Toxin Clearing Dialysis Replacement Injection" will be further improved by 10%, and the toxin clearance rate will reach an astonishing 80%!

The news was like a bombshell, instantly making the much-anticipated "Kidney Toxin Clearing Dialysis Replacement Needle" once again the focus of the dialysis circle.

Mayo Clinic, Dialysis Center.

"Professor Stephen, will you continue to participate in the Phase III clinical trial?"

"Yes, of course! An 80% toxin removal effect! This is almost comparable to a dialysis machine. We can almost reach a level close to that of the human kidney!"

"It's exciting! I have to say that China's Qingshan Pharmaceutical is really amazing. I really love them!"

"Haha, who isn't! I've become their loyal fan now!"

Of course, Zhang Yang could not hear the praise from the other side of the ocean. When the "Kidney Toxin Clearing Dialysis Needle" was about to complete the FDA Phase II clinical trial, he provided the complete product with an effective clearance rate of 80% to Novartis as planned to facilitate their Phase III clinical trial.

In addition, 80% of the complete product was also provided to GlaxoSmithKline, which is conducting phase III clinical trials in India.

And most importantly, Zhang Yang is preparing to start clinical trials of the 80% complete "Kidney Toxin Clearing Dialysis Needle" in China.

Because it is already a complete product, and "Kidney Du Qing" already has sufficient Phase I and Phase II clinical data in the FDA and India, this time, he plans to skip Phase I and Phase II clinical trials and directly try to apply for Phase III clinical trials.

This was not something Zhang Yang came up with on the spur of the moment.

Instead, it is due to the country's continuous support for the research and development of innovative drugs, especially the introduction of several policies on "shortening the approval cycle for innovative drugs" in the past two or three months. One of them is to recognize the results of Phase I and Phase II clinical trials passed by the US FDA, the European Union and the United Kingdom.

but,

When Zhang Yang told Wei Tian his idea, Wei Tian was still a little hesitant.

"Boss, are you sure you want to apply for the third phase directly?"

"You know, although the policy has been issued, it is a trial run. So far, there is still no precedent in the country for a pharmaceutical company to directly apply for Phase III clinical trials..."

Zhang Yang smiled and waved his hand:
"It's okay. Since there is no precedent, we can set it as a precedent. The relevant departments have introduced such a policy, so we should support it, right?"

Qingshan Pharmaceutical's plan to directly apply for Phase III clinical trials for its "Kidney Toxin Clearing Dialysis Replacement Needle" soon reached the relevant office of the State Food and Drug Administration.

In the afternoon,

Chen Gang from the Drug Supervision Section immediately convened a discussion meeting with his direct superiors and technical personnel.

"Director Wei, colleagues, the specific situation is this: Qingshan Pharmaceutical has submitted a clinical trial application for the 'Kidney Toxin Clearing Dialysis Replacement Injection', but what is completely different from before is that they applied to directly conduct a Phase III clinical trial, skipping Phase I and Phase II clinical trials!"

"Of course, they also submitted the Phase I and II clinical data of this drug to the US FDA and India. I have read it and the data is very complete. It can also be found on the official websites of the FDA and India. There is no problem."

Then he said finally:

"Now, we need to make a final decision on whether to allow Qingshan Pharmaceutical's 'Kidney Du Qing Dialysis Needle' to proceed directly to Phase III clinical trials."

After the words were spoken, everyone in the conference room looked normal or even a little excited.

Prior to this, China did not recognize certifications from the FDA and other markets such as the European Union. This resulted in some innovative drugs having to start all over again from Phase I clinical trials in China even if they had been on the market for many years in other markets.

Although it is not completely liberalized now, the policy level has at least made it possible to skip the first and second phases of clinical trials, which undoubtedly saves pharmaceutical companies a lot of time and costs. After a moment, a young technical backbone raised his hand and said:

"I think it's OK. Since the country has already issued relevant policies, as long as the conditions are met, we should naturally approve it and help pharmaceutical companies complete clinical trials quickly!"

After the first person spoke, the second one soon followed.

"I agree. Although no pharmaceutical company has applied for the trial run three months after the details were released, we still have to take the first step. I think it's great that Qingshan Pharmaceutical is taking the lead!"

"Well, their data at the FDA is very complete, and I see no reason not to approve it!"

Everyone was talking at once, and soon everyone's eyes fell on Director Wei, their direct supervisor, who was 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 Phase I and II clinical trials."

"And, comrades, this is the first time in the history of our Huaxia Pharmaceutical's clinical trial approval that we have accepted and recognized clinical data from the mainstream pharmaceutical market with an open attitude."

"Such a gesture will undoubtedly encourage more domestic pharmaceutical companies to go global. They will know that as long as they have the ability and the effect, and as long as the drug passes clinical trials abroad, its data will also be recognized in China, and they will no longer have to worry!"

"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 one more thing he didn't say.

The reason why the system can be promoted to progress so quickly is because of Qingshan Pharmaceutical.

Suddenly, everyone thought of a sentence that they often heard in meetings:

"We need to change our mindset now. Instead of asking pharmaceutical companies like Qingshan Pharmaceutical to adapt to our system, we should optimize our system to adapt to their development..."

I have to say, it’s great to have abilities!

A week later.

Qingshan Pharmaceutical's application for "Kidney Toxin Clearing Dialysis Replacement Needle" to skip Phase I and Phase II clinical trials and directly conduct Phase III clinical trials 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 the FDA and other markets before?

Racial differences, differences in ethical standards, and issues with the reliability of data sources are all reasons.

But the core is:
Before this, there were not many domestic pharmaceutical companies that could sell domestic drugs overseas, and even fewer companies were willing to conduct clinical trials overseas... You know, the cost of clinical trials in the United States and Europe is significantly higher than in China.

As a result, with few pharmaceutical companies and few drugs being tested overseas, what motivation do domestic regulatory agencies have to promote institutional reform?
Now, with Qingshan Pharmaceutical taking the lead, all relevant institutions have been forced to take action.

Compared with the shock in the domestic pharmaceutical industry, domestic dialysis patients were finally very happy and told others about it.

After waiting for more than half a year and seeing a lot of reviews about "Kidney Toxin Clearing" on the Internet, they couldn't wait to try it!
it's good now!

Tsingshan Pharmaceutical's "Kidney Toxin Clearing Dialysis Replacement Injection" is finally going to start clinical trials in the country.

Because this time the trial was directly conducted in the Phase III clinical trial and the total recruitment task was 500 people, Zhang Yang still placed the main trial hospital in Chengdu Third People's Hospital.

Of course, he also did not forget that President Gan of West China University of Medical Sciences had recommended him to attend the "Global Kidney Summit".

In return, 500 of the 150 places were placed in West China Hospital.

Two days later, the recruitment for the Phase III clinical trial of Qingshan Pharmaceutical's "Kidney Toxin Clearing Dialysis Replacement Needle" officially began. At this time, another piece of news came that made Zhang Yang even more concerned.

The "BI-Toxin Filtration Catalyst", independently developed by the German company BI and used to improve the toxin clearance rate in hemodialysis, has completed its Phase I clinical trial, and a large number of clinical results have been published online.

Upon hearing the news, Zhang Yang immediately went to the drug research and development center. He wanted to personally see the clinical phase I data results of the "BI-Toxin Filtration Catalyst".

An hour later, he frowned and looked at Wei Tian beside him.

"From the clinical data alone, this drug clearly did not meet BI's design expectations."

“20份临床一期数据中仅有2份提升了3.5%血液毒素清除率，其余的14份提升仅为2%，剩下的4份更是没有任何提升毒素清除率的效果。”

"This is far from the 7% they expected."

Wei Tian hummed and exhaled gently.

Zhang Yang had always asked him to keep an eye on the developments of BI's drug, so he was naturally very familiar with it.

"Boss, that's true."

“Moreover, I have gradually become pessimistic about the commercial prospects of their catalyst.”

"Ok?"

Zhang Yang was slightly stunned, then said:
"Give your opinion."

"Because you asked me to pay special attention to the research and development progress of this drug, I also carefully studied it."

"This drug is mainly used to improve the effective toxin filtration rate of dialysis patients. The current dialysis machine removal efficiency is about 85%. The cost of each ordinary dialysis in China is about 1000-1200 yuan;
If this drug can only improve the survival rate by 2-3%, I think it will be difficult for hospitals or patients to choose it. "

"After all, increasing the amount of medicine is equivalent to increasing the cost of treatment... I guess BI is also quite disappointed with this result!"

Zhang Yang nodded slightly. 2-3% was indeed a bit low.

After a moment, he said to himself:
"Wei Tian, ​​do you think they have a chance to increase it to 7% after subsequent improvements?"

"do not know."

Wei Tian shook his head honestly.

As a non-core member of the drug, it is unrealistic to confirm the follow-up situation of this drug with certainty.

But after a moment, his eyes lit up:
"Boss, I don't know, but there's someone who might have some clues."

"Who?"

"The person who will be joining us soon is Fang Hanliang, the former top drug developer at BI."

"Fang Hanliang?"

"Well, he should know!"

　There are many people and things to do during the National Day holiday, so there will be fewer updates in the past two days. Everything will return to normal when I start work tomorrow. Thank you for your understanding

　　
　
(End of this chapter)