After being fired, I became the light of medicine

Chapter 8 Did you really develop this?

"This data is really beautiful..."

That afternoon, after Ren Xiaomin carefully read some of the information about "Qingshan Avaqubopa" brought by Zhang Yang, he truly realized that Zhang Yang was not acting rashly, but had really made adequate preparations and had achieved certain results.

He became completely serious and started a heated discussion with Zhang Yang.

About two hours later, the two ended their discussion and soon a complete work plan was produced.

The pharmaceutical, pharmacological and toxicological data of "Qingshan Avatrombopag" are already very complete. The next step is to pass the ethical review before starting phase I and phase II clinical trials.

Ren Xiaomin is more familiar with this matter and he is responsible for applying for clinical trials.

What Zhang Yang needs to do is to produce the "Qingshan Avatrombopag" tablets as soon as possible to be used in phase I and phase II clinical trials!
This was a familiar process for Zhang Yang. He had carefully studied the synthesis route of "Qingshan Avaqubopa" and it was not difficult.

However, the biggest problem at the moment was the lack of a production site. After some discussion, the two finally decided to rent a chemical laboratory for small-scale preparations.

A week later, the first batch of "Qingshan Avatrombopag" preparation with stable quality was successfully produced.

Before the two could be happy, five days later, the Ethics Review Committee also brought good news.

"Avatrombopag" has passed the ethical review and will carry out phase I and II clinical trials in Chengdu Third People's Hospital, Seventh People's Hospital and Second Military Region Hospital.

……

Rongcheng Third People's Hospital is also one of the three hospitals conducting clinical trials of Qingshan Avatrombopag.

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 document.

"Good morning, Director Feng. This is the list of the new batch of clinical drug trials just sent by the pharmacology institute. This time our center has three new drug clinical trial tasks. Please take a look."

"Ah."

Feng Gang nodded and took the document handed to him.

As the deputy director of the hospital's clinical trial center, his main job is to understand, arrange, and orderly complete the clinical trial applications submitted by major pharmaceutical companies and scientific research institutions.

Seeing him start flipping through the pages, the assistant beside him continued:

"Director, there are three new drugs that will be tested in clinical trials this time. The first one is Tirelizumab from Roche in Switzerland, which is mainly used for small cell lung cancer."

"The second one is a new drug from the domestic company Hengrui Pharmaceuticals, which is mainly used to treat Henoch-Schonlein purpura."

"However, I suggest you take a look at the third drug first. This is also a domestic pharmaceutical company, and I am sure you have never heard of it."

"Oh?"

Feng Gang was immediately interested and quickly turned to the last document.

"Qingshan Pharmaceutical? I've never heard of it."

He calmed down and started reading, but after reading only a few pages he started shaking his head.

"'Qingshan Avatrombopag tablets'?"

"What do you want to do? Do you want to make a Chinese version of 'Avatrombopag'?"

"What a joke!"

The assistant couldn't help but laugh.

"That's why I thought it was strange and asked you to take a look at this new medicine first."

"We haven't even figured out how to make generic versions of Eltrombopag in China yet, and there are companies that want to develop Avatrombopag..."

"Moreover, I have checked it out. The treatment effect designed in the clinical plan they submitted is almost exactly the same as that of the overseas 'Avatrombopag'..."

"They don't even want to pass clinical trials, do they?"

Feng Gang lost all interest and threw the document back on the table.

In fact, when every new drug undergoes clinical trials, the pharmaceutical company will first submit a "clinical trial design plan."

Simply put, 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 is ultimately intended to achieve, etc. This is not something that can be written casually. After the clinical trial is completed, the design plan needs to be compared with the clinical results to see whether the actual clinical effect has achieved the original design goal.

This is also one of the key factors in whether a new drug can pass clinical trials.

Now the therapeutic effect of "Qingshan Avatrombopag" is designed to be exactly the same as that of the foreign "Avatrombopag", which obviously does not want to pass clinical trials.

Seeing this, the assistant then asked:

"Director, do you think we can still arrange the clinical trial as usual?"

"Arrange it, why not arrange it!"

Feng Gang snorted:
"Since they are willing to do this, just arrange it normally."

"I want to see whether they have too much money to burn or whether they are really capable of developing such a good drug."

"Ok."

It has to be said that although Feng Gang was not optimistic about Qingshan Avatrombopag at all, the clinical trial center was very efficient.

In addition, the blood diseases and cancers treated by Qingshan Avatrombopag are innovative drugs that are key national support, and phase I and phase II clinical trials can be carried out simultaneously, which also saves a lot of time in recruiting patients.

Soon, the recruitment of the first batch of fifteen patients was completed, and the combined Phase I and Phase II clinical trial of "Qingshan Avatrombopag" officially began.

A week later,

At 7 p.m. on Tuesday, the -day clinical data results of the first batch of subjects of "Qingshan Avatrombopag" were released.

At 2: p.m., the lights in the small conference room No. of the Clinical Trial Center suddenly came on, and an emergency meeting was held.

Feng Gang, who had just received the clinical data, sat right above, and on both sides were the other two core personnel responsible for the clinical trial of "Qingshan Avatrombopag" - Lao Yu and Xiao Gao.

"Old Yu, are you sure the blood test results are OK?"

"Director, I have checked it three times, and there is no problem! I also asked the laboratory to retest the blood sample, and the data results are 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 drugs provided by Qingshan Pharmaceutical, right?"

"Director...there is no problem with the medicine they provide! I have carefully checked several times. The molecular structure of their medicine is completely different from the foreign 'Avatrombopag'. I can be 100% sure that what they provide is definitely not the foreign 'Avatrombopag tablets'!"

"That's weird!"

Feng Gang stood up immediately and threw the data in his hand onto the table, his face full of disbelief.

"Since there is no error in the data and the drug is not counterfeit, can their 7-day treatment effect really reach the level of 'Avatrombopag' abroad?!"

“7日血小板计数提升到50×109· L-1以上，7日应答率达到65.5%，所有试验组患者肝肾功能低于正常值，这不就是‘阿伐曲泊帕’吗？”

"Tell me, have they really developed a drug similar to 'Avatrombopag'?!"

Lao Yu and Xiao Gao looked at each other, and neither of them could answer.

As frontline 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!
In fact, it is not inferior to the top foreign drugs!
At this moment, they were no less shocked than Feng Gang!
The conference room suddenly fell into a brief silence, but fortunately, after a while, the atmosphere eased a little.

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, have arrived. They want to see the latest clinical data results."

"Do you think you can let them come over?"

When he heard Zhang Yang's name, a light flashed in Feng Gang's eyes.

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)