Chapter 122 There is a problem in the clinical trial of the Kidney Toxin Clearing Dialysis Injection! (Please subscribe)
In the hearts of all people in Sichuan Province, West China Hospital is the top hospital.
It is no exaggeration to say that this is the last hope for tens of millions of people in Sichuan Province at this critical moment.
After confirming his identity, captain Luo respectfully opened the door and allowed Gan Weiguo to enter the Qingshan Pharmaceutical office area.
Zhang Yang was also very surprised by Dean Gan's personal visit and hurriedly stood up from his chair to greet him.
As mentioned just now, West China Hospital is not only famous throughout the country, but more importantly, it is the last patron saint of the people of Sichuan Province.
Such a hospital deserves respect.
"Dean Gan, why are you here in person? Please take a seat, please take a seat."
Zhang Yang's enthusiastic attitude made Dean Gan feel slightly relieved, and said with a smile:< br>
“Mr. Zhang, will I not disturb you by coming here?”
"No, no, you are welcome to come anytime."
"Xiao Liu, bring over the tea I just bought, and I will personally make a cup for Dean Gan."
The words fell. , assistant Xiao Liu hurriedly took out the tea leaves from the cabinet, and waited for a while After the leaves were brewed, Gan Weiguo picked up the tea cup and took a sip:
“Good tea.”
Zhang Yang suddenly laughed. His tea was just an ordinary one or two hundred yuan a piece. It's just a kilogram of tea leaves. It can only be said to be drinkable, but it cannot be said to be good tea.
However, the unfamiliarity between the two of them dissipated a lot because of his smile.
Seeing this, Gan Weiguo immediately said:
"Mr. Zhang, I have actually wanted to visit you in person for a long time, but I just didn't have time, so I delayed it."
"I hope you won't take it to heart when you 'Qingshan Afa' entered us. I really didn't know about it at the time..."
Before he finished speaking, Zhang Yang interrupted with a smile and waved his hand:< br>
"Gan Yuan, you are worrying too much. If you didn't mention this matter, I would have forgotten it; don't worry, we don't care about it at all."
Zhang Yang was speaking from his heart. Not only him, but also probably even Ren Xiaomin, who had handled this matter in the first place, had completely forgotten about it.
"That's good."
Gan Weiguo nodded. In his mind, he always thought that this incident affected Qingshan Pharmaceutical's attitude towards Huaxi. Now that it's out of the question, it can be regarded as a painting. Ended.
After chatting for a few more words, he gradually brought the topic to the ultimate purpose of his visit.
"Mr. Zhang, our Qingshan Pharmaceutical has developed excellent drugs in the fields of blood diseases and liver diseases. I wonder if you are interested in the field of kidney diseases?"
Zhang Yang suddenly felt a little strange and said curiously:
“What’s wrong?”
“It’s nothing.”
Gan Weiguo stopped beating around the bush when he saw this, and probed more bluntly:
"You should know that there is an organization called 'International Society of Nephrology' in the world, right? They hold a 'Kidney Disease Summit' every two years. This year in China, our West China Hospital and Peking University Hospital received the invitation."
" Because we made a major scientific breakthrough in kidney transplantation last year, the association awarded a recommendation quota this year, which means that we can invite a pharmaceutical company to participate in this global kidney disease summit. ”
< br>"I have been thinking about you and Qingshan Pharmaceutical, but I don't know if you are interested in participating."
After the words fell, Gan Weiguo added when Zhang Yang looked startled. :
“Of course, a special note, although your company has not yet produced any drug results in the field of kidney disease, Tsingshan Pharmaceutical’s current international reputation is enough to participate in this summit.”
"I'm thinking that if you plan to do some drug research and development in the field of kidney disease in the next few years, this summit will be a good opportunity. At least we can communicate more and get to know more foreign kidney disease pharmaceutical companies."
< br>Zhang Yang understood completely at this time, and couldn't help but secretly wonder. He didn't expect that Dean Gan came to send him an invitation letter this time.
However, this invitation letter is indeed a sleepy pillow. Currently, my "Kidney Toxin Clearing Dialysis Injection" is about to undergo clinical trials. If I use this opportunity to make it public on such an important forum, it will be a good idea. Not a bad way to go.
Thinking of this, the smile on his face became brighter:
"Dean Gan, thank you for remembering Qingshan Pharmaceutical. We do have ideas to develop kidney disease drugs."
"That's just right!"
Dean Gan's expression suddenly relaxed, and he hurriedly smiled and said:
"Then I will report your names to the association when I get back, and you should be there in a few days. Can receive an invitation letter from the association , you will join on time.”
“Okay!”
Zhang Yang was not polite to Gan Weiguo. The result was that the guests and hosts had a good time. After greeting each other for about ten minutes, Gan Weiguo left. leave.
After watching Gan Weiguo's car drive out of the park, Zhang Yang returned to the office, and then carefully learned about the "Global Kidney Disease Summit" on the Internet.
The level of the summit that Gan Weiguo personally invited was naturally not low. After learning more about it, Zhang Yang was even more determined to officially reveal the "Kidney Toxin Clearing Dialysis Needle" at the summit.
Gan Weiguo was very efficient. Within a few days, Zhang Yang received an invitation letter from the "International Society of Nephrology", inviting Qingshan Pharmaceutical to participate in the "Global Kidney Disease Conference" to be held in Shanghai in two months. Academic Summit”.
At the same time, Zhang Yang also received a reply from Fang Hanliang.
After a few days of consideration, Fang Hanliang has decided to officially join Tsingshan Pharmaceutical, but before that he has to return to BI Company in Germany to handle the resignation procedures and all contract issues.
Zhang Yang was naturally quite happy.
At present, the main products of Qingshan Pharmaceutical are derived from system output. The only disadvantage is that the rewards are too random; if you can have your own drug research and development team, it can be used as a supplement to the simulator rewards, and it can be targeted to develop drugs for some diseases.
After handling these two matters, Zhang Yang immediately shifted the focus of his work to the "Kidney Toxic Clear Dialysis Replacement Injection". The current focus of his work is to complete animal experiments within two months and apply for clinical trials. One issue.
Like all previous new drugs, in order to make the research and development process of "Shenduqing Replacement Injection" seem more reasonable and smoother, Zhang Yang still only provided Wei Tian's team with an effective clearance rate of 50%. of semi-finished products.
He still hopes to improve it step by step from the first clinical phase to the finished product in the third clinical phase as before.
Wei Tian and his team members are also accustomed to this research and development model in which Zhang Yang proposes solutions and ideas, and then they improve and perfect them step by step.
However,
Just when Zhang Yang was fully expecting the "Kidney Toxin Clearing Dialysis Injection" to complete the animal experiment, Wei Tian suddenly broke into the office early in the morning.
He was holding a thick stack of information in his hand, with a stern look on his face, and Zhang Yang was surprised as soon as he opened his mouth.
"Mr. Zhang, serious problems have arisen in animal testing. Several experimental animals have died in the past two days."
"Animal died? What's going on?"
Zhang Yang quickly took the data handed over by Wei Tian. After carefully examining it for a few minutes, he immediately understood what went wrong.
Like other innovative drugs, "Kidney Toxic Clear Dialysis Injection" needs to complete complete animal experiments before applying for Phase I clinical trials.
Animal experiments are mainly divided into two stages.
The first stage is to verify that the drug is injected into the experimental body. For example, if it is injected into the body of mice and experimental monkeys, it will produce serious side effects. If so, then what is the approximate dosage unit that will produce strong side effects? ?
This is also testing drug toxicity, which is to provide pharmaceutical companies with sufficient data reference when they are actually applied in human trials in the first phase of clinical trials.
The second stage is the therapeutic effect of the drug, the technical term is pharmacodynamic testing.
To put it simply, Qingshan Pharmaceutical's "dialysis needle" is aimed at uremia patients. First, the mice need to suffer from kidney disease similar to uremia, and then the mice are injected with "Kidney Toxic Clear". "Dialysis needle" to monitor and analyze the toxicity and drug effect of "dialysis needle" in mice.
Not only mice, but also closer to the human body, experimental monkeys suffering from uremia will also conduct the same animal experiments!
The problem this time occurs at this step!
In the past, whether it was the hepatotoxic "Ecofovir" in clinical trials or the "hepatocellular activator" in clinical trials, the patients in the trial group would take the best first-line treatment drugs while taking the new drugs.
For example, when testing "Ekofovir", the test group took "Ekofovir" and at the same time the best hepatitis B inhibitory drug "Tenofovir alafenamide". In the same way, patients with liver cirrhosis also take "hepatocyte activators" while undergoing traditional treatment for liver cirrhosis.
The purpose is that even if the new drug has no therapeutic effect, the subjects will not worsen their condition due to clinical trials. This is to ensure the safety of the subjects.
What about this time’s “Kidney Toxin Clearing Dialysis Needle”?
Because the toxin removal effect is only 50%, and animal experiments cannot allow animals to undergo dialysis, after long-term accumulation of toxins, experimental monkeys suffering from uremia began to die in large numbers in just two weeks.
This is not the most important thing. The most important thing is that Wei Tian realized an extremely serious problem -
If the existing "Kidney Toxin Clear Dialysis" with a therapeutic clearance rate of only 50% is used When "needle" is used in human clinical trials, a clearance rate of 50% will inevitably result in a large amount of toxins that cannot be excreted from the human body. Clinical trials of one week, two weeks, or as long as three months will definitely cause difficult-to-evaluate harm to the patient, and even death. !
Thinking of this, Zhang Yang took a deep breath, looked at Wei Tian seriously, and said:
"In response to this problem, how are you preparing to respond to clinical trials?"
Wei Tian said in a deep voice:
“The current method I am thinking of is to have the subjects undergo dialysis every two injections. However, even this method will cause the subjects to have at least five days in a week. The toxin residues are more than 50%, and it is difficult to say whether it will cause harm to the subjects. "
"And this frequency is already acceptable to us. The limit! If we go to dialysis every time we give an injection, we can't verify the clinical effect of this drug."
"And even with this frequency, I'm not sure whether the ethics committee will approve us. Clinical trials, after all, this method has great safety risks for the lives of the subjects."
Zhang Yang nodded.
He remembered that the instructions for the "Kenduqing Dialysis Injection" recommended that no more than two injections should be used in a row, and dialysis should be performed at most every five days.
This is true even for complete products, let alone semi-finished products with a clearance rate of 50%!
Thinking of this,
Zhang Yang frowned slightly. He was not completely helpless.
The most direct way is to directly use the "Kidney Toxin Clearing Dialysis Needle" with a clearance rate of 80% in the finished product into the first phase of clinical trials. However, in this way, "clinical is the finished product", which is difficult to avoid. People are suspicious!
For a time, Zhang Yang was in a dilemma.
On the one hand, it is the life safety of the subjects, and on the other hand, it is the biggest secret of Qingshan Pharmaceutical. It is difficult to make a choice.
"Wei Tian, please follow the normal animal experiment procedures first, and I'll think about it again."
"By the way, you can also ask the ethics committee to help evaluate it and see if it's in accordance with your How risky is the plan of dialysis after two injections?”
“Good!”
Wei Tian also knew the troubles of this clinical trial of "Kidney Toxin Clearing Dialysis Injection", so he responded and immediately dealt with the matter.
In the next few days, Zhang Yang kept thinking about this matter, but no matter how much he thought about it, he could not find a perfect solution.
In desperation, he decided to first increase the effective clearance rate of the "Kidney Toxin Clearing Dialysis Injection" to 60%.
The R&D team is very efficient, and with Zhang Yang personally joining in, the clearance rate was increased from 50% to 60% in just one month.
The improved "Kidney Toxin Clearing Dialysis Needle" significantly improved the survival period in animal experiments. Not long after, the ethics committee also issued an evaluation report to evaluate the improved "Kidney Toxin Clearing Dialysis Needle" For - high risk (unknown unknown risk).
This makes the "Kidney Clear Dialysis Injection" the same as the last time "Ecofovir". If clinical trials are to be conducted, many unknown risks must be explained and the subjects must be informed in detail.
However, Zhang Yang knew that the side effects of this "Kidney Clear Dialysis Injection" are likely to be higher than those of the last "Ecofovir".
Just when Zhang Yang was hesitant to apply for the first phase of clinical trials, the "Global Nephrology Summit" organized by the "International Society of Nephrology" was quietly approaching.
With no other choice, Zhang Yang had no choice but to let go of his hesitation and come to the Magic City for the time being. No matter what, he still had to announce this "Kidney Toxin Clearing Dialysis Needle" to the outside world first.
August 1st, Jinmao Grand Hyatt Hotel in Shanghai.
Jinmao Grand Hyatt Hotel is located in the Lujiazui Financial and Trade Zone. It has a wide view and overlooks the beautiful scenery of the entire city. Therefore, it has become the venue for many important and large-scale business meetings.
At 8:30 a.m., Zhang Yang arrived at the "Alice" conference hall mentioned in the invitation letter on time.
At this time, many doctors were already present in the conference hall, and soon he was guided by the on-site staff to the seat of pharmaceutical company representatives on the right side of the conference hall.
As soon as he sat down, he began to observe the doctors invited to the meeting.
According to the participant list provided by the organizer, those who are here today are the top nephrologists from major hospitals around the world.
Two domestic doctors from West China Hospital and Peking University School of Medicine were invited to participate. Others, such as the National Hospital of Singapore, Europe and the United States, also sent several top doctors to participate in the exchange.
While Zhang Yang was looking at everyone, many doctors also noticed Zhang Yang.
Especially when they saw Zhang Yang sitting on the seat with the "Qingshan Pharmaceutical" nameplate, many doctors talked a lot.
“This is the boss of Qingshan Pharmaceutical? He looks very young.”
“That should be true, but Qingshan Pharmaceutical doesn’t seem to have any drugs for kidney disease. I’m just here to mess around. Does he look familiar? ”
"I don't know. It is said that the organizer did not invite it, but it was recommended by West China Hospital."
The sound of everyone's discussion inevitably fell on Zhang Yang's ears, and he smiled slightly and didn't care.
According to the meeting process arranged by the organizer, four top doctors shared some kidney disease treatment options and the latest surgical cases in the morning.
Reports and discussions on the latest kidney drugs from major pharmaceutical companies , then we have to wait until the afternoon.
Just when Zhang Yang calmed down and prepared to listen to this high-end academic conference, a familiar figure suddenly appeared in front of Zhang Yang.
It’s Gan Weiguo, the director of West China Hospital.
"Mr. Zhang, you are here so early for the 9 o'clock academic meeting?"
"And the morning seminar is mainly for academic exchanges between doctors, and pharmaceutical company representatives usually come in the afternoon. ”
Only then did Zhang Yang understand why the seats on the side of the pharmaceutical company representatives were empty, with only a few people here.
However.
Even though he was here, Zhang Yang was too lazy to leave again.
"It's okay, I can also listen to the academic conference."
"Okay."
A smile appeared on Gan Weiguo's face, and he thought about the current situation of Qingshan Pharmaceutical There is no drug for kidney disease.
Then he said:
"Mr. Zhang, don't be stressed. The main purpose of coming this time is to show your face."
"In the afternoon pharmaceutical company exchange meeting, you can listen to the latest results of other pharmaceutical companies, which may help you develop kidney drugs in the future. It helps too."
Zhang Yang smiled and nodded.
Not long after, the time came to 9 o'clock, and the biennial "Global Nephrology Summit" officially kicked off.
……
PS: If I fail every day, I am a waste.
(End of this chapter)