Chapter 8 Is this really developed by you?
"This data is indeed very beautiful..."
On the afternoon of that day, after Ren Xiaomin carefully read some of the "Qingshan Avatrombopag" information brought by Zhang Yang, this was the real moment. Realize that Zhang Yang is by no means a hothead, but is really well prepared and has achieved certain results.
He became completely serious and started a heated discussion with Zhang Yang.
After about two hours, the two ended their discussion, and soon a complete work plan was released.
The pharmaceutical, pharmacology and toxicology data of "Qingshan Avatrombopag" are already very complete, and it only needs to pass the ethical review before the first and second clinical trials can be carried out.
Ren Xiaomin is familiar with this matter, and he is responsible for applying for clinical trials.
What Zhang Yang wants to do is to produce "Qingshan Avatrombopag" tablets that will be used in Phase I and Phase II clinical trials as soon as possible!
This is a familiar path for Zhang Yang. He has carefully studied the synthesis route of "Qingshan Avatrombopag" and it is not difficult.
But the biggest problem right now is that there is no production space. After some discussion, the two finally decided to rent a chemical laboratory for small-scale preparation.
One week later, the first batch of "Qingshan Avatrombopag" preparation with stable quality was successfully produced.
Before the two were happy, five days later, good news came from the Ethics Review Committee.
"Avatrombopag" has passed the ethical review and will start clinical phase I and II trials at the Third People's Hospital, the Seventh People's Hospital and the Second Military Region Hospital in Chengdu.
……
Rongcheng Third People’s Hospital is also one of the three hospitals where “Qingshan Avatrombopag” is undergoing clinical trials.
Early in the morning, Deputy Director Feng Gang of the Clinical Trial Center appeared in the office on time.
After a while, a young assistant knocked on the door with a piece of information.
"Good morning, Director Feng, this is a new batch of clinical drug trial lists that have just been sent from the pharmacological institution. This time our center has three new drug clinical trial tasks. Please take a look."
"Yes. .”
Feng Gang nodded and immediately took the handed document.
As the deputy director of the hospital's clinical trial center, his main job is to understand, arrange, and orderly complete clinical trial applications submitted by major pharmaceutical companies and scientific research institutions.
Seeing him start browsing, the assistant on the side continued:
"Director, there are three new drugs to be tested in clinical trials this time. The first one is Tirellid from the Swiss company Roche. Especially, it is mainly used for small cell lung cancer ”
“ The second is a new drug from the domestic company Hengrui Pharmaceutical, which is mainly used for the treatment of allergic purpura.”
“However, I suggest you take a look at the third drug first, which is also a domestic pharmaceutical company. I'm sure you haven't heard of it."
"Oh?"
Feng Gang was immediately aroused and quickly turned to the last document.
"Qingshan Pharmaceutical? I really haven't heard of it."
He calmly began to read, but he shook his head after reading a few pages.
“‘Qingshan Avatrombopag Tablets’?”
"What do you want to do? Want to make a domestic version of 'Avatrombopag Tablets'?"
"Are you kidding me!"
The assistant couldn't help laughing.
“That’s why I find it strange that I let you take a look at this new drug first.”
“At present, the domestic version of ‘Eltrombopag’ has not even been figured out yet, and there are actually The company wants to develop 'Avatrombopag'..."
"Moreover, I have specifically checked. In the clinical plan they submitted, the designed treatment effect is almost exactly the same as that of the foreign 'Avatrombopag'..."
"They didn't even think about it. Passed the clinical trial?”
Feng Gang lost interest at all and threw the document directly back on the table.
In fact, when every new drug is undergoing clinical trials, the pharmaceutical company will first submit a "clinical trial design plan."
To put it simply, this plan needs to explain which diseases this new drug can be used for, which patients it can be used for, whether it is used for adjuvant treatment or first-line treatment, what kind of therapeutic effect it will ultimately achieve, etc. This is not something you can just slap on the head and write randomly. After the clinical trial is completed, the design plan needs to be compared with the clinical results to see whether the actual clinical effect meets the original design goals.
And this is also one of the key factors that determine whether a new drug can pass clinical trials.
The therapeutic effect of "Qingshan Avatropopag" is now designed to be exactly the same as that of foreign "Avatropopag", which obviously does not want to pass clinical trials.
Seeing this, the assistant then asked:
"Director, do you think we can still arrange clinical trials as normal?"
"Arrangement, why not arrange it!"
Feng Gang snorted:
"Since they are willing to do this, just arrange it normally."
"I want to take a look. Are they running out of money, or are they really capable of developing such a good medicine?"
"Okay."
It has to be said that although Feng Gang is not optimistic about "Avatrombopag" at all, the clinical trial center is very efficient.
In addition, the hematological diseases treated by "Qingshan Avatrombopag" are innovative drugs supported by the state as well as cancer. The first and second clinical phases can be carried out at the same time, which also saves a lot of money in recruiting patients. less time.
Soon, the first batch of fifteen patients was recruited, and the combined phase I and phase II clinical trials of "Avatrombopag Qingshan" officially began.
One week later,
Tuesday, at 2 p.m., the 7-day clinical data results of the first batch of subjects of "Avatrombopag" were released.
At 2:05 in the afternoon, the lights in the small conference room No. 2 of the clinical trial center suddenly turned on, and an impromptu meeting was held urgently.
Feng Gang, who had just received the clinical data, was sitting directly above him, flanked by two other core personnel responsible for the clinical trial of "Qingshan Avatrombopag" - Lao Yu and Xiao Gao.
"Lao Yu, are you sure the blood test results are OK?"
"Director, I have checked it three times and there is no problem! And I also asked people from the laboratory department to re-test the blood The specimen was tested twice, and the data results were all correct."
Feng Gang's expression changed, he took a deep breath and looked at Xiao Gao on the other side:
"Xiao Gao, that means there is something wrong with the medicines provided by Qingshan Pharmaceutical, right?"
"Director... there is nothing wrong with the medicines they provide! I have carefully checked several times, and their medicines are the same as foreign ones." Valtrombopag's molecular structure is completely different, I can be 100% sure that what they provide is definitely not the foreign 'avatrombopag tablets'!"
"That's strange!"
Feng Gang stood up immediately and said: He threw the data in his hand on the table with disbelief on his face.
“Since the data is not wrong and the medicine is not fake, then their 7-day treatment effect can really reach the level of foreign ‘Avatrombopag’?!”
"The platelet count increased to above 50×109·L-1 on the 7th day, the response rate on the 7th day reached 65.5%, and the liver and kidney functions of all patients in the trial group were lower than normal values. Isn't this 'Avatrombopag'?"< br>
“Tell me, have they really developed the same drug as ‘Avatrombopag’?!”
Lao Yu and Xiao Gao looked at each other, neither of them could answer.
As front-line members who have worked in the clinical center for more than ten years, they have never seen any innovative drug achieve such excellent therapeutic effects!
Even, it is not inferior to top foreign drugs at all!
At this moment, they were no less shocked than Feng Gang!
The conference room suddenly fell into a brief silence. Fortunately, after a while, the atmosphere calmed down slightly.
At this moment, the door of the conference room was suddenly pushed open.
"Director Feng, Zhang Yang and Ren Xiaomin, the heads of Qingshan Pharmaceutical, are here. They want to check the latest clinical data results."
"Do you want them to come over?"
Hearing Zhang Yang's name, Feng Gang's eyes flashed with light.
After a moment, he took a deep breath and nodded.
Soon, Zhang Yang and Ren Xiaomin came to the conference room. As soon as they sat down, Director Feng Gang, who was always serious, suddenly looked at Zhang Yang.
"Hello, Mr. Zhang, is this really developed by you?"
(End of this chapter)