After Wei Kang heard this, he couldn't help but fell silent.
Gu Xian's actions were, in fact, absolutely wrong from a legal perspective, and a sentence of several years would not be an exaggeration.
But from the perspective of the patients and their families, not only is it innocent, it is simply the reincarnation of the savior.
He felt complicated at the moment and didn't know what to say.
After a while, he said: "Let's leave your contact information and I will contact you when the test results come out."
"If the sample is as good as you say, then I'm interested."
"But this is your hard work after all. I won't take it for free. I will give you a satisfactory price."
"I am as urgent as you are about the generic clobazam drug and will push it to market as soon as possible. Don't worry."
Gu Xian nodded, feeling relieved, he took a long breath, left his contact information and left.
Wei Kang looked at his back and had a vague feeling that maybe they would cooperate in the future.
In fact, he sympathized a little with Gu Xian, who was also a poor person.
There is also some admiration. After all, making homemade anti-cancer drugs for my mother is not something ordinary people can do.
Even if ordinary people have this idea, they don’t have the practical ability and technical level.
Just like himself, if it weren't for the system, he might not be as good as Gu Xian.
However, he still had some doubts about what Gu Xian said about improving the prescription process and crystal structure.
It is not easy to make generic drugs. Can we make improvements on this basis?
Is a folk pharmacist really that powerful?
You should know that although the technical requirements of generic drugs are not comparable to those of original drugs, there are still thresholds in the production process.
If it were really that easy, the reputation of domestic pharmaceutical companies' generic drugs wouldn't be so bad.
Drugs on the market can be divided into innovative drugs and generic drugs. Innovative drugs, also called original drugs, have the latest and best efficacy, but are often expensive. Generic drugs are low-priced imitations of innovative drugs that are similar in safety and efficacy after the patent expires.
The patent term for originator drugs is usually 20 years. In other words, companies that are not capable of R&D will have to wait 20 years even if they want to copycat.
For 20 long years, those who unfortunately got sick could only buy expensive original drugs. Although the country includes some expensive original drugs every year, the majority of original drugs that require 100% self-pay are always in the majority.
There are currently about 20,000 innovative drugs under research in the world, of which Eagle Country accounts for 50% and Europa accounts for 40%. The two have almost blocked the neck of the world. As for China, because it has only begun to exert its efforts in recent years, it is only 3%.
As for generic drugs that have been authorized during the patent protection period, they are also expensive, mainly because of the extremely high licensing fees.
Last year, domestic Fosun Pharma obtained a license for the original drug rzl-012 from an overseas company. In addition to receiving a licensing fee of up to US$74 million, the latter also received a certain percentage of sales commission in the future. There is no doubt that the huge cost will eventually be passed on to consumers.
And once you cross the threshold of patents, everything is not worry-free. Copycatting of drugs is actually not as easy as imagined.
All the knowledge points of chemistry are in the books, but domestic generic drug companies who read the books only scored 60 points on the test. It is generally believed that a drug can be called a generic drug if its efficacy reaches 80% of the original drug.
The main reason for the cheapness of generic drugs is that there are no patent fees. The drug molecules and efficacy are known. They can be copied according to the ingredient list without any technical difficulty. Moreover, as long as they are pharmaceutically equivalent to the reference preparation, even clinical trials can be saved. After that, basically only the production cost remains.
The reason why Tianzhu's generic drugs are so cheap is that they ignore patents roguely, leaving only production costs.
But this is not allowed in China. As a big country, China cannot ignore the patent period of original drugs. Therefore, if domestic pharmaceutical companies want to produce generic drugs, they must either wait for the patent to expire or become invalid, or purchase patent licenses.
In addition to finding the drug molecules, the difficulty of original research drugs is to verify the efficacy. Clinical trials are mainly to verify the efficacy. The requirements in this regard are very strict, resulting in a large amount of sunk costs and R&D investment.
How strict is it? For example, the active ingredient content of a certain patent medicine is 99.5%, and the other 0.5% is impurities. There are two main impurities in 0.1%, and the remaining 0.3% is ten small-dose impurities. Then the structure of all 12 impurities must be determined, separated and purified, and each of them must undergo complete clinical and pharmacological studies, including toxicology, to ensure that these 12 impurities do no harm to the human body before they can be qualified.
These can be omitted from generic drugs, thereby significantly reducing costs and making them affordable.
But this does not mean that generic drugs do not have any technical content.
Because in addition to the same drug molecules, generic drugs must be consistent with the original drug in terms of active ingredient content, drug purity, uniformity, disintegration time, dissolution rate, as well as absorption and metabolism in the body.
This means that in the process of turning drug molecules into drugs, the intermediate links must maintain a certain level of technology, so that the resulting drugs can maintain consistent efficacy.
Every aspect of this is important. The crystal structure can make the drug more pure, more stable, and better absorbed in the body. The preparation process can keep the blood drug concentration within the ideal range for a long enough time, or even The presence of some of these impurities will have an important impact on the efficacy of the drug, such as the occurrence of some side effects.
The most basic requirement for consistency evaluation is that the purity of generic drugs cannot be lower than that of the original drug, and the purity of the generic drug cannot exceed that of the original drug. If the purity and quality of generic drugs do not meet standards, they will not be able to pass the consistency evaluation and will not be eligible to participate in centralized procurement bidding.
If a pharmaceutical company can make drugs with higher purity and fewer impurities by improving the process, it will not only be easier to gain market recognition, but the price of the drug can be higher. It can even apply to the Food and Drug Administration to improve drug quality standards and eliminate competitors. To gain market advantage abroad.
In short, the technical content of the drug preparation process is very important, which determines whether the efficacy of a generic drug is 40%, 60%, or 80% of the original drug.
The gap in R&D level and manufacturing technology has caused the dilemma faced by ordinary people, that is, innovative drugs cannot be afforded and generic drugs are less effective.
Even if pharmaceutical companies like Sanqing are willing to invest money and manpower to produce generic drugs, this cannot be changed overnight.
Most patients would rather choose to buy high-priced imported drugs than cheap domestic generic drugs. This situation may still be common for a long time to come.
The clobazam generic drug currently being approved by Sanqing is to directly purchase foreign original drugs and make reference preparations to develop its own prescription process. Even this step will take several months.
If there is a ready-made prescription process, these few months can be completely omitted and clinical trials of consistent drug efficacy can be conducted directly, and the time to market can be greatly accelerated.
"Let's wait for the test results of the samples to come out and see if that kid is bragging."
Wei Kang waited suspiciously until the afternoon, almost finished all the matters at hand, and headed towards the laboratory where the samples were tested.
As soon as he went out, he ran into Wen Renlong. He shouted at the top of his lungs from a distance: "Boss, what's strange? What's strange? I heard that a counterfeit medicine dealer came to our place to sell prescriptions? Haha, I don't even know where this place is. ?”
Wei Kang was speechless for a moment. How could this person, a pharmacist with a master's degree in pharmacy, become a counterfeit medicine dealer? It's really spreading lies. Besides, they are not here to sell prescriptions, but to provide technical information.
He couldn't help but shake his head and strode into the laboratory.
As soon as I entered, I saw a dark group of people gathered together, and there was a constant buzz of discussion.
Wen Renlong came in on his heels and shouted, "What are you doing?"
The crowd immediately fell silent and dispersed, revealing the person at the end, who was none other than Li Zhong. He was holding a stack of test reports in his hand and was muttering excitedly.
"Wow, the measured values of impurity types and contents in the sample are much lower than those in the reference preparation. No new impurities were detected."
“The comparison of the dissolution curves in four dissolution media showed that the sample was extremely homogeneous, and the coefficient of variation of the dissolution results was less than 3%.”
"The drug has shown extremely high stability under high temperature, high humidity, and light tests, and after passing the forced degradation test and the influencing factor test."
"Hell, if it weren't for the different adjuvant content, I would have thought I was testing the original drug!"
"Ahem!" Wei Kang coughed and said, "Li Zhong, have you finished the test? What's the result?"
Li Zhong looked up, his eyes shining and said: "Mr. Wei, this sample is great. I have tested the ingredients. It is no different from the original drug. I still need some time to do the bioequivalence test before I can submit it." Final Results."
"What? Is it really that powerful?" Wen Renlong stepped forward and snatched the inspection report, looking at it carefully.
After reading it, he immediately exclaimed: "Yes, is this the counterfeit drug dealer's homemade medicine? The level of craftsmanship is something, no worse than the original drug developed by a foreign company. Moreover, the crystal structure is also different, both stable and It’s not too stable, it’s a great balance.”
"The impurity content is also very low. In this way, the side effects will be greatly reduced. Awesome!" He saw obviously much more than Li Zhong, and immediately praised the preparation process of this sample.
After saying that, he slapped his thigh and came over with a smile: "Boss, this is a rare senior researcher of crystal forms. Do you think you can recruit him and put him in my group?"
Before he finished speaking, a voice suddenly intervened and said: "No, such a powerful person must belong to our group."
At first glance, it was Chen Yiqing who strode in, reached out and grabbed the test report, and admired it while reading it.
After reading it, he handed it to Tang Que behind him, but looked at Wei Kang with intense eyes: "Mr. Wei, our team has multiple tasks and we need a powerful crystal form and preparation scientist. This person belongs to me. "
Come on, now all the lab leaders are here, and they all look very aggressive.
Wei Kang suddenly felt dizzy and looked at Tang Que: "What about you, are you here to rob someone too?"
Tang Que slowly looked through the test report, shook his head and said, "No, I came to see the excitement. The biology laboratory is not in use for the time being."
Wen Renlong suddenly became furious: "Do you look down on chemists or something?"
Wei Kang quickly said: "This depends on the person's own wishes. I'll ask him."
He looked at the motionless people in front of him and looked at him expectantly. He suddenly understood, so he took out his cell phone on the spot and called Gu Xian.
"Hello, Gu Xian, right? My name is Wei Kang. We are very interested in your preparation technology. By the way, are you willing to work in Sanqing? The conditions are easy to negotiate."
After a while, Gu Xian's disbelieving voice came from the phone.
"Mr. Wei, you...don't you care about my criminal record?"
Wei Kang chuckled and said: "I don't care. Are you willing to come? If not, we can buy your technical information..."
"Yes!" Gu Xian said firmly, "However, I hope to join the orphan drug generic program."
"Uh," Wei Kang quietly turned on the speakerphone: "Well, you want to make a generic version of an orphan drug, right? No problem."
As he spoke, he winked at Chen Yiqing and Wen Renlong. It was obvious that this counterfeit drug dealer only wanted to make generic drugs, so he had to respect their wishes.
A trace of disappointment flashed across Chen Yiqing's face, but he didn't say much and just nodded.
Wen Renlong patted him on the shoulder angrily: "Old Chen, why did you give up? I'm so greedy for such excellent wild seedlings. Now that you've entered Sanqing, why don't you try to find a way to get there? Well, I didn’t say that I would only make generic drugs for the rest of my life, you, hehe.”
The corners of Chen Yiqing's mouth twitched, but he thought deeply, and a smile suddenly appeared on his face.
