I can extract side effects.
Chapter 112
Chapter 112
After hearing this, Wei Kang couldn't help but fell silent.
These behaviors of Gu Xian, in fact, from a legal point of view, must be a big mistake, and it is not too much to sentence him for several years.
But from the perspective of patients and their families, not only is he innocent, but he is simply the savior reborn.
He was in a complicated mood for a moment, not knowing what to say.
After a while, he opened his mouth and said: "Well, leave a contact information, and I will contact you when the test results come out."
"If the sample is really as good as you say, then I'm very 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 about the generic clobazam, and I will promote it to the market as soon as possible. Don't worry."
Gu Xian nodded, feeling relieved, he let out a long breath, left his contact information and left.
Looking at his back, Wei Kang had a vague feeling that maybe they would cooperate again in the future.
In fact, he had some sympathy for Gu Xian, and he was also a poor man.
There is still some admiration, after all, it is not something ordinary people can do to make homemade anticancer drugs for the mother.
Even if ordinary people have this idea, they don't have the hands-on 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, but can we make improvements on this basis?
Is a folk pharmacist really so powerful?
You should know that although the technical requirements of generic drugs cannot be compared with those of original drugs, there are still thresholds in the production process.
If it were really that easy, the reputation of domestic pharmaceutical companies for generic drugs would not be so bad.
Drugs on the market can be divided into innovative drugs and generic drugs.Innovative drugs, also called original research drugs, have the latest and best curative effect, but the price is often high.Generic drugs are low-cost imitations that are similar in safety and efficacy after the patent of the innovative drug expires.
The patent term of the original drug is usually 20 years.In other words, companies without the ability to engage in research and development will have to wait 20 years even if they want to copycats.
In the long 20 years, the unfortunate people who got sick could only buy expensive original research medicines.Although the country introduces some expensive original research drugs every year, the majority of original research drugs require 100% self-funding on the whole.
At present, there are about 2 innovative drugs under research in the world, of which Eagle Country accounts for 50% and Europa accounts for 40%. The two are almost stuck in the necks of the world.As for Huaxia, since it has only started to make efforts in recent years, it is only 3%.
As for the generic drugs authorized during the patent protection period, the price is also high, mainly because the authorization fee is extremely high.
Last year, the domestic Fosun Pharma obtained the license authorization of the original drug RZL-012 from an overseas company. In addition to obtaining a licensing fee of up to US$7400 million, the latter will also take a certain percentage of sales commissions in the future.There is no doubt that the huge cost will eventually be passed on to consumers.
And crossing the threshold of patents does not mean everything is safe. The counterfeiting of drugs is actually not as easy as imagined.
All the knowledge points of chemistry are in the books, but the domestic generic drug companies who read the book only scored 60 points in the test, and it is generally believed that the efficacy of the drug reaches 80% of the original drug to be called a generic drug.
The cheapness of generic drugs is mainly due to the fact that there is no patent fee, and the drug molecule and efficacy are known. It can be copied as long as it follows the ingredient list without technical difficulty. Moreover, as long as it is pharmaceutically equivalent to the reference drug, even clinical trials can be saved. Basically, only the production cost remains.
The reason why Tianzhu's generic drugs are so cheap is that they ignorantly ignore patents, leaving only production costs.
But this is not allowed in China. As a big country, it is impossible for China to ignore the patent period of the original drug. Therefore, if domestic pharmaceutical companies want to produce generic drugs, they must wait for the patent to expire or become invalid, or purchase a patent license.
In addition to finding the drug molecule, the difficulty of the original drug is to verify the efficacy of the drug. Clinical trials are mainly to verify the efficacy of the drug. This aspect is 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% are ten small-dose impurities.Then the structure of all these 12 kinds of impurities must be determined, separated and purified, and each of them must be completely clinical and pharmacological, including toxicology, to confirm that these 12 kinds of impurities are not harmful to the human body before they can be qualified.
And generic drugs can save these, thereby greatly reducing costs and achieving low prices.
But this does not mean that generic drugs do not have any technical content.
Because in addition to the same drug molecule, the generic drug must be consistent with the original drug in terms of active ingredient content, drug purity, uniformity, disintegration time, dissolution rate, absorption in the body, and metabolism.
This means that in the process of turning drug molecules into drugs, the intermediate links must maintain a considerable level of technology, so that the drugs that come out can maintain the same efficacy.
Each of these links is very important. The crystal structure can make the drug more pure, more stable in structure, and better absorbed in the body. The preparation process can keep the blood drug concentration in the ideal range for a long enough time, 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 the generic drug 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 the standards, they will not pass the consistency evaluation and will not be eligible to participate in the centralized bidding.
If a pharmaceutical company can improve the process to make the drug more pure and less impurity, not only will it be easier to gain market recognition, the price of the drug can be sold at a higher price, and it can even apply to the Food and Drug Administration to improve the quality standard of the drug and exclude competitors. to gain market advantage.
In short, the technical content of pharmaceutical preparations is very important, which determines whether the efficacy of a generic drug is 40%, 60%, or 80% of that of the original drug.
The gap in research and development level and manufacturing process has caused the dilemma faced by ordinary people, that is, innovative drugs cannot be afforded, and generic drugs are ineffective.
Even if a pharmaceutical company like Sanqing is willing to invest money and manpower in the production of generic drugs, that cannot be changed overnight.
Most patients would rather choose to buy high-priced imported drugs than cheap domestic generic drugs, and this situation may still prevail for a long time in the future.
The generic clobazam drug currently approved by Sanqing is to directly purchase foreign original research 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, it is possible to omit these months and directly conduct clinical trials with consistent drug effects, then the time to market can be greatly accelerated.
"Just wait for the test results of the sample to come out and see if that kid is bragging."
Wei Kang waited suspiciously until the afternoon, almost dealt with the matters at hand, and then headed towards the laboratory for sample testing.
As soon as he went out, he ran into Wen Renlong head-on, and he shouted from a distance: "Boss, it's a strange thing, a strange thing, I heard that there is a counterfeit drug dealer here to sell prescriptions? Hehe, I don't even know what kind of place this is." ?”
Wei Kang was speechless for a while, this man is a pharmacist with a master's degree in pharmacy, how did he become a counterfeit drug dealer?It's really spreading rumors, besides, they are not here to sell prescriptions, but to provide technical information.
He shook his head involuntarily, and strode into the laboratory.
As soon as I entered, I saw a dark group of people gathered together, buzzing and discussing endlessly.
Wen Renlong came in on his heels, and when he saw this, he immediately roared: "What are you doing?"
The crowd fell silent immediately, and dispersed, revealing the innermost person, it was Li Zhong, who was holding a stack of test reports in his hand, and was muttering excitedly.
"Wow, the measured value of the type and content of impurities in the sample is much lower than that of the reference preparation. No new impurities were detected."
"The comparison of the dissolution curves in the four dissolution media shows that the sample uniformity is extremely high, and the coefficient of variation of the dissolution results is lower than 3%."
"Drugs are tested under high temperature, high humidity, and light, and after the comparison of the forced degradation test and the impact factor test, the stability is extremely high."
"Damn it, if it wasn't for the different content of the excipients, I would have thought I was testing the original drug!"
"Cough!" Wei Kang coughed and said, "Li Zhong, have you finished the test? How's the result?"
Li Zhong looked up, his eyes lit up and said: "Mr. Wei, this sample is so good, I just did a component test, and it is no different from the original drug. I still need a little time to do a bioequivalence test before I can submit it. Final result."
"What? Really so powerful?" Wen Renlong stepped forward and snatched the inspection report with his hands, and looked at it carefully.
After reading it, he immediately exclaimed: "Yes, is this the self-made medicine of the counterfeit drug dealer? There is something about the level of craftsmanship, which is no worse than the original drug developed by a foreign company. Moreover, the crystal structure is different, stable and stable. It’s not overly stable, and it’s wonderfully balanced.”
"The impurity content is also very low. In this way, the side effects will be greatly reduced. Awesome!" He saw more things than Li Zhong, and immediately praised the preparation process of this sample.
After finishing speaking, he slapped his thigh, approached with a smile and said, "Boss, this is a rare senior crystal researcher. Can you recruit him and put him in my group?"
Before he finished speaking, a voice suddenly came in and said, "No, such a powerful person should belong to our team anyway."
Upon seeing it, it was Chen Yiqing who strode in, stretched out his hand to grab the test report, and sighed in admiration while reading it.
After reading it, he handed it to Tang Que behind him, but looked at Wei Kang with fiery eyes: "Mr. Wei, our team has a lot of tasks, and we need a powerful crystal form and preparation scientist, and this person belongs to me. "
Come on, now all the lab leaders are here, and they all look aggressive.
Wei Kang's head suddenly became dizzy, and he looked at Tang Que: "What about you, are you also here to rob people?"
Tang Que slowly flipped through the test report, shook his head and said, "No, I'm here to see the excitement. The biology laboratory is not needed for the time being."
Wen Renlong suddenly became angry: "Are you looking 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 few people in front of him who were motionless and looked at him expectantly, and suddenly realized, so he took out his mobile phone on the spot and called Gu Xian.
"Hi, is Gu Xian right? I'm Wei Kang, that's it. 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 unbelievable 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 Project."
"Uh," Wei Kang quietly turned on the speakerphone: "Well, you want to make generic drugs for orphan drugs, 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, and he had to respect their wishes.
A trace of disappointment flashed across Chen Yiqing's face, but he didn't say much, just nodded.
Wen Renlong patted him on the shoulder resentfully: "Old Chen, why did you give up? I'm jealous of such an excellent wild seedling. Now that you've entered Sanqing, why don't you think of trying to abduct it?" Well, they didn’t say that they would only make generic drugs for the rest of their lives, you, hehe.”
The corner of Chen Yiqing's mouth twitched for a while, but he thought so deeply in his heart, and a smile suddenly appeared on his face.
Thanks to book friend 20200824164443128 for the 400 reward.
(End of this chapter)
After hearing this, Wei Kang couldn't help but fell silent.
These behaviors of Gu Xian, in fact, from a legal point of view, must be a big mistake, and it is not too much to sentence him for several years.
But from the perspective of patients and their families, not only is he innocent, but he is simply the savior reborn.
He was in a complicated mood for a moment, not knowing what to say.
After a while, he opened his mouth and said: "Well, leave a contact information, and I will contact you when the test results come out."
"If the sample is really as good as you say, then I'm very 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 about the generic clobazam, and I will promote it to the market as soon as possible. Don't worry."
Gu Xian nodded, feeling relieved, he let out a long breath, left his contact information and left.
Looking at his back, Wei Kang had a vague feeling that maybe they would cooperate again in the future.
In fact, he had some sympathy for Gu Xian, and he was also a poor man.
There is still some admiration, after all, it is not something ordinary people can do to make homemade anticancer drugs for the mother.
Even if ordinary people have this idea, they don't have the hands-on 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, but can we make improvements on this basis?
Is a folk pharmacist really so powerful?
You should know that although the technical requirements of generic drugs cannot be compared with those of original drugs, there are still thresholds in the production process.
If it were really that easy, the reputation of domestic pharmaceutical companies for generic drugs would not be so bad.
Drugs on the market can be divided into innovative drugs and generic drugs.Innovative drugs, also called original research drugs, have the latest and best curative effect, but the price is often high.Generic drugs are low-cost imitations that are similar in safety and efficacy after the patent of the innovative drug expires.
The patent term of the original drug is usually 20 years.In other words, companies without the ability to engage in research and development will have to wait 20 years even if they want to copycats.
In the long 20 years, the unfortunate people who got sick could only buy expensive original research medicines.Although the country introduces some expensive original research drugs every year, the majority of original research drugs require 100% self-funding on the whole.
At present, there are about 2 innovative drugs under research in the world, of which Eagle Country accounts for 50% and Europa accounts for 40%. The two are almost stuck in the necks of the world.As for Huaxia, since it has only started to make efforts in recent years, it is only 3%.
As for the generic drugs authorized during the patent protection period, the price is also high, mainly because the authorization fee is extremely high.
Last year, the domestic Fosun Pharma obtained the license authorization of the original drug RZL-012 from an overseas company. In addition to obtaining a licensing fee of up to US$7400 million, the latter will also take a certain percentage of sales commissions in the future.There is no doubt that the huge cost will eventually be passed on to consumers.
And crossing the threshold of patents does not mean everything is safe. The counterfeiting of drugs is actually not as easy as imagined.
All the knowledge points of chemistry are in the books, but the domestic generic drug companies who read the book only scored 60 points in the test, and it is generally believed that the efficacy of the drug reaches 80% of the original drug to be called a generic drug.
The cheapness of generic drugs is mainly due to the fact that there is no patent fee, and the drug molecule and efficacy are known. It can be copied as long as it follows the ingredient list without technical difficulty. Moreover, as long as it is pharmaceutically equivalent to the reference drug, even clinical trials can be saved. Basically, only the production cost remains.
The reason why Tianzhu's generic drugs are so cheap is that they ignorantly ignore patents, leaving only production costs.
But this is not allowed in China. As a big country, it is impossible for China to ignore the patent period of the original drug. Therefore, if domestic pharmaceutical companies want to produce generic drugs, they must wait for the patent to expire or become invalid, or purchase a patent license.
In addition to finding the drug molecule, the difficulty of the original drug is to verify the efficacy of the drug. Clinical trials are mainly to verify the efficacy of the drug. This aspect is 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% are ten small-dose impurities.Then the structure of all these 12 kinds of impurities must be determined, separated and purified, and each of them must be completely clinical and pharmacological, including toxicology, to confirm that these 12 kinds of impurities are not harmful to the human body before they can be qualified.
And generic drugs can save these, thereby greatly reducing costs and achieving low prices.
But this does not mean that generic drugs do not have any technical content.
Because in addition to the same drug molecule, the generic drug must be consistent with the original drug in terms of active ingredient content, drug purity, uniformity, disintegration time, dissolution rate, absorption in the body, and metabolism.
This means that in the process of turning drug molecules into drugs, the intermediate links must maintain a considerable level of technology, so that the drugs that come out can maintain the same efficacy.
Each of these links is very important. The crystal structure can make the drug more pure, more stable in structure, and better absorbed in the body. The preparation process can keep the blood drug concentration in the ideal range for a long enough time, 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 the generic drug 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 the standards, they will not pass the consistency evaluation and will not be eligible to participate in the centralized bidding.
If a pharmaceutical company can improve the process to make the drug more pure and less impurity, not only will it be easier to gain market recognition, the price of the drug can be sold at a higher price, and it can even apply to the Food and Drug Administration to improve the quality standard of the drug and exclude competitors. to gain market advantage.
In short, the technical content of pharmaceutical preparations is very important, which determines whether the efficacy of a generic drug is 40%, 60%, or 80% of that of the original drug.
The gap in research and development level and manufacturing process has caused the dilemma faced by ordinary people, that is, innovative drugs cannot be afforded, and generic drugs are ineffective.
Even if a pharmaceutical company like Sanqing is willing to invest money and manpower in the production of generic drugs, that cannot be changed overnight.
Most patients would rather choose to buy high-priced imported drugs than cheap domestic generic drugs, and this situation may still prevail for a long time in the future.
The generic clobazam drug currently approved by Sanqing is to directly purchase foreign original research 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, it is possible to omit these months and directly conduct clinical trials with consistent drug effects, then the time to market can be greatly accelerated.
"Just wait for the test results of the sample to come out and see if that kid is bragging."
Wei Kang waited suspiciously until the afternoon, almost dealt with the matters at hand, and then headed towards the laboratory for sample testing.
As soon as he went out, he ran into Wen Renlong head-on, and he shouted from a distance: "Boss, it's a strange thing, a strange thing, I heard that there is a counterfeit drug dealer here to sell prescriptions? Hehe, I don't even know what kind of place this is." ?”
Wei Kang was speechless for a while, this man is a pharmacist with a master's degree in pharmacy, how did he become a counterfeit drug dealer?It's really spreading rumors, besides, they are not here to sell prescriptions, but to provide technical information.
He shook his head involuntarily, and strode into the laboratory.
As soon as I entered, I saw a dark group of people gathered together, buzzing and discussing endlessly.
Wen Renlong came in on his heels, and when he saw this, he immediately roared: "What are you doing?"
The crowd fell silent immediately, and dispersed, revealing the innermost person, it was Li Zhong, who was holding a stack of test reports in his hand, and was muttering excitedly.
"Wow, the measured value of the type and content of impurities in the sample is much lower than that of the reference preparation. No new impurities were detected."
"The comparison of the dissolution curves in the four dissolution media shows that the sample uniformity is extremely high, and the coefficient of variation of the dissolution results is lower than 3%."
"Drugs are tested under high temperature, high humidity, and light, and after the comparison of the forced degradation test and the impact factor test, the stability is extremely high."
"Damn it, if it wasn't for the different content of the excipients, I would have thought I was testing the original drug!"
"Cough!" Wei Kang coughed and said, "Li Zhong, have you finished the test? How's the result?"
Li Zhong looked up, his eyes lit up and said: "Mr. Wei, this sample is so good, I just did a component test, and it is no different from the original drug. I still need a little time to do a bioequivalence test before I can submit it. Final result."
"What? Really so powerful?" Wen Renlong stepped forward and snatched the inspection report with his hands, and looked at it carefully.
After reading it, he immediately exclaimed: "Yes, is this the self-made medicine of the counterfeit drug dealer? There is something about the level of craftsmanship, which is no worse than the original drug developed by a foreign company. Moreover, the crystal structure is different, stable and stable. It’s not overly stable, and it’s wonderfully balanced.”
"The impurity content is also very low. In this way, the side effects will be greatly reduced. Awesome!" He saw more things than Li Zhong, and immediately praised the preparation process of this sample.
After finishing speaking, he slapped his thigh, approached with a smile and said, "Boss, this is a rare senior crystal researcher. Can you recruit him and put him in my group?"
Before he finished speaking, a voice suddenly came in and said, "No, such a powerful person should belong to our team anyway."
Upon seeing it, it was Chen Yiqing who strode in, stretched out his hand to grab the test report, and sighed in admiration while reading it.
After reading it, he handed it to Tang Que behind him, but looked at Wei Kang with fiery eyes: "Mr. Wei, our team has a lot of tasks, and we need a powerful crystal form and preparation scientist, and this person belongs to me. "
Come on, now all the lab leaders are here, and they all look aggressive.
Wei Kang's head suddenly became dizzy, and he looked at Tang Que: "What about you, are you also here to rob people?"
Tang Que slowly flipped through the test report, shook his head and said, "No, I'm here to see the excitement. The biology laboratory is not needed for the time being."
Wen Renlong suddenly became angry: "Are you looking 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 few people in front of him who were motionless and looked at him expectantly, and suddenly realized, so he took out his mobile phone on the spot and called Gu Xian.
"Hi, is Gu Xian right? I'm Wei Kang, that's it. 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 unbelievable 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 Project."
"Uh," Wei Kang quietly turned on the speakerphone: "Well, you want to make generic drugs for orphan drugs, 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, and he had to respect their wishes.
A trace of disappointment flashed across Chen Yiqing's face, but he didn't say much, just nodded.
Wen Renlong patted him on the shoulder resentfully: "Old Chen, why did you give up? I'm jealous of such an excellent wild seedling. Now that you've entered Sanqing, why don't you think of trying to abduct it?" Well, they didn’t say that they would only make generic drugs for the rest of their lives, you, hehe.”
The corner of Chen Yiqing's mouth twitched for a while, but he thought so deeply in his heart, and a smile suddenly appeared on his face.
Thanks to book friend 20200824164443128 for the 400 reward.
(End of this chapter)
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