Chapter 676 Research and development? Bullshit research and development!
In these three months, the new liver drug department has repeatedly created miracles.
The day after CRM197 was selected as the target, Xu Qiu provided 230 compounds that were effective on the target.
Three weeks later, the research team screened out 17 compounds with significant effects.
The next day, Xu Qiu selected No. 7 as the lead compound.
In the following month, the R\u0026D department designed and synthesized a large number of new compounds around the lead compound No. 7.
According to the conventional drug development process, the structure-activity relationship of the synthesized compound data and the chemical structure should be analyzed at this time...
But this list was sent to Xu Qiu again.
Three days later, thousands of new compounds were re-screened, and only 61 remained on the list.
The three academicians and researchers such as Han Chang were shocked.
Just ruled out?
Other pharmaceutical companies need several years of screening steps, but Xu Qiu did it in three days?
Everyone doubted and analyzed the structure-activity relationship of the 61 compounds, and then gradually optimized and modified the structure.
Soon, after three rounds of selection, we finally got the best compound that meets the basic biological activity!
Looking at the compound No. 7 isolated in the sterile warehouse, everyone couldn't help but get excited...
The candidate drug has been selected!
The formal research and development phase is about to begin!
It is also called preclinical research.
At present, they have only proved that the compound No. 7 can target the CRM197 target and play a role in targeted therapy, but there is still a long way to go from a compound to a mature drug.
The goal of the first stage is toxicology research.
Whether the drug has efficacy is secondary, at least it should not cause unexpected harm to patients!
Of course, wanting to conduct toxicology research is also a very tedious and complicated process.
First of all, it is necessary to report to the Food and Drug Administration and submit an application for "experimental new drugs". The second step is to develop the synthesis process of raw materials.
Today's compound No. 7 comes out of the laboratory. Careful preparation and mass production are two concepts.
The first step is to continuously improve and perfect the mass production process, and then use the first batch of raw materials produced for toxicology research.
"Report to Dr. Xu!"
"Toxicology must be given a green channel by the higher authorities!"
Everyone in the R\u0026D department was extremely anxious.
Toxicology research must be completed in the shortest possible time. This is also a rare step in drug development that can ignore costs. Only if the pharmaceutical route can achieve toxicological batch synthesis can this compound have the possibility of becoming a drug.
Otherwise, all previous efforts will be in vain.
It is equivalent to everyone waiting for toxicology research. The longer it is delayed, the higher the time cost will be. Therefore, it is possible to ignore economic costs and develop at all costs...
...
Baiyun Pharmaceutical Factory, Xu Qiu's office.
Three academicians and chief researchers such as Han Chang knocked on the door and entered, and reported the latest progress at the same time.
Han Chang said: "Doctor Xu, according to the general process, it may take several months or even a year to approve the application for experimental new drugs..."
Several academicians also looked helpless.
Even if they are leading the R\u0026D project, it will take at least a week to pass the review of the Food and Drug Administration.
This is still based on the premise that they are academicians and have jumped the queue for the application form.
I just don't know when Xu Qiu's application will be approved.
"I didn't expect that we would be stuck by this kind of thing after working non-stop on research and development..."
"There is nothing we can do about it. Drugs are related to people's livelihood and health. Without a comprehensive investigation, how can it have the opportunity to flow into the clinic? This system was also formulated after many lessons."
"That being said, according to the previous efficiency, whether our new liver drug can be completed within the deadline is still uncertain..."
The new liver drug department is too large.
Now everyone has to wait for the approval of new drugs for experiments, and can only sit there, but various experimental equipment, compounds, etc. cannot stop. If they do nothing every day, the loss can reach tens of millions... If they delay for a few days, one hundred million will be gone!
Five billion seems to be a lot, but for drug research and development with a cost of tens of billions, it is quite tight. Every penny must be used on the cutting edge...
Now it's just a waste, and the money lost is really painful!
"Well, I have reported it."
After Xu Qiu finished speaking, he looked at the time and said, "It should be about time."
"When?" Several academicians were stunned for a moment and didn't understand what he meant.
Ding-ling-ling!
Xu Qiu's phone suddenly rang.
He picked it up naturally, and after hanging up, he looked at everyone and said, "The Food and Drug Administration has passed the review and is preparing for toxicology research immediately."
"What?!"
"Done?"
"Doctor Xu, you..."
Han Chang and others were so shocked that they were speechless... Is this the speed of the scientific research project guaranteed by the two ministers?
"Doctor Xu, we will immediately take people to carry out the research and development of the raw material synthesis process..." Han Chang said impatiently.
There are four stages in this link.
The first stage is naturally the laboratory research stage, where researchers accurately prepare drugs to meet the requirements of experiments, etc. Compound No. 7 is now in this stage.
The second is the small-scale trial production stage. The purpose is to comprehensively and systematically reform and improve the original synthesis routes and methods in the laboratory, and to propose a synthesis process route that is basically suitable for small-scale production.
If you want to conduct toxicological research, you must at least reach the small-scale trial production stage.
At this time, in addition to research on toxicology, efficacy, etc., what needs to be done is to find out whether industrial-grade raw materials and solvents interfere with the reaction, and whether they have any impact on the yield and quality of the drug.
Once the small-scale trial production process is perfected, it will basically enter the pilot production stage.
The last stage is the industrial production stage, and only then can we truly enter market-oriented mass production.
Of course, the distance between the latter two is too far now. What the new liver drug needs to do is to explore a process route for small-scale trial production and first meet the needs of toxicological research.
However, before Han Chang and several academicians left the office, Xu Qiu pulled out a piece of information from the bottom of the drawer.
"This is..." Han Chang's eyelids twitched and his breathing became rapid.
Xu Qiu said calmly: "Synthetic route in the small-scale trial production stage."
The three academicians were all stunned, looking at Xu Qiu with eyes full of confusion and shock.
With all this research and development, Xu Qiu even fed the new liver medicine into their mouths!
…
Soon, the toxicological study results of Compound No. 7 will be released!
Like sorafenib and lenvatinib, Compound No. 7 has not been studied on fertility, but repeated dose toxicity studies in experimental animals such as rats, monkeys, and dogs have shown that Compound No. 7 has the potential to affect fertility. Influence.
