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In addition to increasing indications, most of the "reforms" are based on pharmaceutical research, that is, using various mature or iterative new pharmaceutical technologies and even medical device technologies to further improve compounds that have been clinically verified.
The core element is to conduct in-depth research on the products that have been marketed, and to explore the elements that can be improved in clinical or pharmacy.
For example, if the drug is poorly absorbed, it can be changed to a prodrug to increase the dissolution of the drug in the body; to improve the first pass effect, consider bypassing the oral route and develop intravenous or inhaled preparations; develop new dosage forms suitable for children or neurological fields.
With the rapid development of technology, some medical device drug loading and digital technology have also been applied to drug improvement.
The core element is to conduct in-depth research on the products that have been marketed, and to explore the elements that can be improved in clinical or pharmacy.
For example, if the drug is poorly absorbed, it can be changed to a prodrug to increase the dissolution of the drug in the body; to improve the first pass effect, consider bypassing the oral route and develop intravenous or inhaled preparations; develop new dosage forms suitable for children or neurological fields.
With the rapid development of technology, some medical device drug loading and digital technology have also been applied to drug improvement.
For improved new drugs, especially when the regulatory authorities approve such new drugs, they pay more attention to the "good" characteristics.
In other words, compared with the original product, the clinical effect can be "good" through the "reform" of pharmacy.
In fact, it can also be seen in previous successful products that this "good" result can to a certain extent consolidate the clinical position of the product or expand new therapeutic areas and extend the product life cycle.
In other words, compared with the original product, the clinical effect can be "good" through the "reform" of pharmacy.
In fact, it can also be seen in previous successful products that this "good" result can to a certain extent consolidate the clinical position of the product or expand new therapeutic areas and extend the product life cycle.
The way to improve aripiprazole
From the perspective of international experience, the improvement of aripiprazole is worth learning from local pharmaceutical companies who hope to improve the quality of their products .
Aripiprazole is the first product of Japan's Otsuka Pharmaceutical.
Otsuka Pharmaceutical has continued its patent through various means until 2015.
During this period, the various characteristics and formulations of the product have been continuously enriched and improved, with peak sales approaching US$4 billion.
Facing the patent cliff and a series of challengers, Otsuka Pharmaceutical has developed ultra-long-acting preparations for more than one month, so that the company still has a sales share of more than $1 billion after the expiration of the drug patent.
At the same time, the company has also developed me bet er's next-generation product, epipiprazole.
Although the above-mentioned newly developed varieties did not reach the peak sales of aripiprazole, it also helped companies avoid a cliff-like decline in performance after the patent expired, which is a successful improvement case.
Otsuka Pharmaceutical has continued its patent through various means until 2015.
During this period, the various characteristics and formulations of the product have been continuously enriched and improved, with peak sales approaching US$4 billion.
Facing the patent cliff and a series of challengers, Otsuka Pharmaceutical has developed ultra-long-acting preparations for more than one month, so that the company still has a sales share of more than $1 billion after the expiration of the drug patent.
At the same time, the company has also developed me bet er's next-generation product, epipiprazole.
Although the above-mentioned newly developed varieties did not reach the peak sales of aripiprazole, it also helped companies avoid a cliff-like decline in performance after the patent expired, which is a successful improvement case.
In addition to directly imitating the original products, Otsuka Pharmaceutical's competitor, Alker Mes, Ireland, has also achieved positive results through improved methods.
Alker Mes seized the opportunity to develop a long-acting suspension injection of lauroyl aripiprazole micro-crystals, which was launched in 2015.
Later, in 2018, micron-sized lauroyl aripiprazole particles were launched.
Both can reach a dosing cycle of 6 weeks to 2 months, and are still gaining market share.
Alker Mes seized the opportunity to develop a long-acting suspension injection of lauroyl aripiprazole micro-crystals, which was launched in 2015.
Later, in 2018, micron-sized lauroyl aripiprazole particles were launched.
Both can reach a dosing cycle of 6 weeks to 2 months, and are still gaining market share.
The story of aripiprazole's improvement continues.
In 2017, Otsuka Pharmaceutical launched the world's first digital aripiprazole tablet.
After the patient takes it, the chip in the tablet will react with gastric acid, send out a signal and transmit it to the mobile phone to realize digital tracking.
This project opened up a new era of the integration of smart sensor technology and pharmaceutical preparation technology.
In 2017, Otsuka Pharmaceutical launched the world's first digital aripiprazole tablet.
After the patient takes it, the chip in the tablet will react with gastric acid, send out a signal and transmit it to the mobile phone to realize digital tracking.
This project opened up a new era of the integration of smart sensor technology and pharmaceutical preparation technology.
There are also many successful experiences of this kind in China, such as the improvement case of amlodipine.
Judging from the sales of calcium antagonists in the past ten years, the improved product levalamlodipine has risen rapidly after its launch, surpassing the old-brand drugs felodipine and nimodipine in a short period of time, and even surpassed after the collection effect.
Amlodipine.
However, the success of this improved new drug is based on the advantages of amlodipine.
On a superimposed basis, levoamlodipine saved the market position of amlodipine after intensified imitation (see figure).
Judging from the sales of calcium antagonists in the past ten years, the improved product levalamlodipine has risen rapidly after its launch, surpassing the old-brand drugs felodipine and nimodipine in a short period of time, and even surpassed after the collection effect.
Amlodipine.
However, the success of this improved new drug is based on the advantages of amlodipine.
On a superimposed basis, levoamlodipine saved the market position of amlodipine after intensified imitation (see figure).
Improved innovation has obvious advantages
For original research pharmaceutical companies that are in a leading position in a certain field, improved innovation can also form a certain period of market exclusivity, and companies can avoid the risk of original research patent cliffs through improvements.
For challengers, improved innovations can help companies avoid becoming victims in the "fight against imitations", and seek to borrow from the improvement of original research products.
For challengers, improved innovations can help companies avoid becoming victims in the "fight against imitations", and seek to borrow from the improvement of original research products.
Compared with the development of innovative drugs, improved new drugs have the characteristics of low investment and low risk.
At the same time, thanks to the successful experience of the original research drug market, the improved new drugs have higher clinical acceptance and faster profit returns.
The author believes that improved innovation will become the golden track for the next round of transition from Chinese pharmaceutical companies to innovative pharmaceutical companies.
At the same time, thanks to the successful experience of the original research drug market, the improved new drugs have higher clinical acceptance and faster profit returns.
The author believes that improved innovation will become the golden track for the next round of transition from Chinese pharmaceutical companies to innovative pharmaceutical companies.
Medical Network News, May 31.
With the continuous escalation of national medical insurance control fees, centralized procurement has been normalized and accelerated, and pharmaceutical companies with generic drugs as the core have to face the test of life and death.
If the company does not have the ability to integrate the industrial chain and cannot form manufacturing resources or technological advantages, in the current homogenized competition pattern based on the comprehensive promotion of the quality and efficacy of generic drugs, price wars will become the main response to centralized procurement.
the way.
With the continuous escalation of national medical insurance control fees, centralized procurement has been normalized and accelerated, and pharmaceutical companies with generic drugs as the core have to face the test of life and death.
If the company does not have the ability to integrate the industrial chain and cannot form manufacturing resources or technological advantages, in the current homogenized competition pattern based on the comprehensive promotion of the quality and efficacy of generic drugs, price wars will become the main response to centralized procurement.
the way.
In order to cope with the Chinese->Innovation is of course the eternal way for pharmaceutical companies to survive and develop.
However, disruptive innovation has a large investment, long cycle, and high risk, and not all companies have the ability and resources to carry out.
Improved innovation based on existing products and market iterations is a wise choice for some companies to break through the siege and gain a new life.
However, disruptive innovation has a large investment, long cycle, and high risk, and not all companies have the ability and resources to carry out.
Improved innovation based on existing products and market iterations is a wise choice for some companies to break through the siege and gain a new life.
"Reform" and "good" are the soul of improved new drugs
"Reform" and "good" are the soul of improved new drugs Improved innovation is an important link in the transition of some domestic pharmaceutical companies to subversive innovation in the future.
Although the development cycle and capital investment of improved innovation are much larger than those of generic drugs, the greater success rate and easier market promotion have prompted some pharmaceutical companies to make improved innovation the key to development in the next 10 years.
Of course, the company must first consider the basis of the project and the development strategy.
Although the development cycle and capital investment of improved innovation are much larger than those of generic drugs, the greater success rate and easier market promotion have prompted some pharmaceutical companies to make improved innovation the key to development in the next 10 years.
Of course, the company must first consider the basis of the project and the development strategy.
The industry generally believes that my country’s improved innovation is consistent with the management scope of 505b(2) in the United States, and the various classifications of 505(b)2 correspond to the 2 new drugs of general chemical drugs in my country.
However, in the actual application, companies need to truly understand the main points of improved new drugs-"reform" and "good" are the soul of improved new drugs.
However, in the actual application, companies need to truly understand the main points of improved new drugs-"reform" and "good" are the soul of improved new drugs.
In addition to increasing indications, most of the "reforms" are based on pharmaceutical research, that is, using various mature or iterative new pharmaceutical technologies and even medical device technologies to further improve compounds that have been clinically verified.
The core element is to conduct in-depth research on the products that have been marketed, and to explore the elements that can be improved in clinical or pharmacy.
For example, if the drug is poorly absorbed, it can be changed to a prodrug to increase the dissolution of the drug in the body; to improve the first pass effect, consider bypassing the oral route and develop intravenous or inhaled preparations; develop new dosage forms suitable for children or neurological fields.
With the rapid development of technology, some medical device drug loading and digital technology have also been applied to drug improvement.
Medical equipment medical equipment medical equipment children children childrenThe core element is to conduct in-depth research on the products that have been marketed, and to explore the elements that can be improved in clinical or pharmacy.
For example, if the drug is poorly absorbed, it can be changed to a prodrug to increase the dissolution of the drug in the body; to improve the first pass effect, consider bypassing the oral route and develop intravenous or inhaled preparations; develop new dosage forms suitable for children or neurological fields.
With the rapid development of technology, some medical device drug loading and digital technology have also been applied to drug improvement.
For improved new drugs, especially when the regulatory authorities approve such new drugs, they pay more attention to the "good" characteristics.
In other words, compared with the original product, the clinical effect can be "good" through the "reform" of pharmacy.
In fact, it can also be seen in previous successful products that this "good" result can to a certain extent consolidate the clinical position of the product or expand new therapeutic areas and extend the product life cycle.
In other words, compared with the original product, the clinical effect can be "good" through the "reform" of pharmacy.
In fact, it can also be seen in previous successful products that this "good" result can to a certain extent consolidate the clinical position of the product or expand new therapeutic areas and extend the product life cycle.
The way to improve aripiprazole
The way to improve aripiprazole From the perspective of international experience, the improvement of aripiprazole is worth learning from local pharmaceutical companies who hope to improve the quality of their products .
Product Quality Product Quality Product Quality Enterprise Enterprise Enterprise Aripiprazole is the first product of Japan's Otsuka Pharmaceutical.
Otsuka Pharmaceutical has continued its patent through various means until 2015.
During this period, the various characteristics and formulations of the product have been continuously enriched and improved, with peak sales approaching US$4 billion.
Facing the patent cliff and a series of challengers, Otsuka Pharmaceutical has developed ultra-long-acting preparations for more than one month, so that the company still has a sales share of more than $1 billion after the expiration of the drug patent.
At the same time, the company has also developed me bet er's next-generation product, epipiprazole.
Although the above-mentioned newly developed varieties did not reach the peak sales of aripiprazole, it also helped companies avoid a cliff-like decline in performance after the patent expired, which is a successful improvement case.
Medicine, medicine, medicineOtsuka Pharmaceutical has continued its patent through various means until 2015.
During this period, the various characteristics and formulations of the product have been continuously enriched and improved, with peak sales approaching US$4 billion.
Facing the patent cliff and a series of challengers, Otsuka Pharmaceutical has developed ultra-long-acting preparations for more than one month, so that the company still has a sales share of more than $1 billion after the expiration of the drug patent.
At the same time, the company has also developed me bet er's next-generation product, epipiprazole.
Although the above-mentioned newly developed varieties did not reach the peak sales of aripiprazole, it also helped companies avoid a cliff-like decline in performance after the patent expired, which is a successful improvement case.
In addition to directly imitating the original products, Otsuka Pharmaceutical's competitor, Alker Mes, Ireland, has also achieved positive results through improved methods.
Alker Mes seized the opportunity to develop a long-acting suspension injection of lauroyl aripiprazole micro-crystals, which was launched in 2015.
Later, in 2018, micron-sized lauroyl aripiprazole particles were launched.
Both can reach a dosing cycle of 6 weeks to 2 months, and are still gaining market share.
Alker Mes seized the opportunity to develop a long-acting suspension injection of lauroyl aripiprazole micro-crystals, which was launched in 2015.
Later, in 2018, micron-sized lauroyl aripiprazole particles were launched.
Both can reach a dosing cycle of 6 weeks to 2 months, and are still gaining market share.
The story of aripiprazole's improvement continues.
In 2017, Otsuka Pharmaceutical launched the world's first digital aripiprazole tablet.
After the patient takes it, the chip in the tablet will react with gastric acid, send out a signal and transmit it to the mobile phone to realize digital tracking.
This project opened up a new era of the integration of smart sensor technology and pharmaceutical preparation technology.
In 2017, Otsuka Pharmaceutical launched the world's first digital aripiprazole tablet.
After the patient takes it, the chip in the tablet will react with gastric acid, send out a signal and transmit it to the mobile phone to realize digital tracking.
This project opened up a new era of the integration of smart sensor technology and pharmaceutical preparation technology.
There are also many successful experiences of this kind in China, such as the improvement case of amlodipine.
Judging from the sales of calcium antagonists in the past ten years, the improved product levalamlodipine has risen rapidly after its launch, surpassing the old-brand drugs felodipine and nimodipine in a short period of time, and even surpassed after the collection effect.
Amlodipine.
However, the success of this improved new drug is based on the advantages of amlodipine.
On a superimposed basis, levoamlodipine saved the market position of amlodipine after intensified imitation (see figure).
Judging from the sales of calcium antagonists in the past ten years, the improved product levalamlodipine has risen rapidly after its launch, surpassing the old-brand drugs felodipine and nimodipine in a short period of time, and even surpassed after the collection effect.
Amlodipine.
However, the success of this improved new drug is based on the advantages of amlodipine.
On a superimposed basis, levoamlodipine saved the market position of amlodipine after intensified imitation (see figure).
Improved innovation has obvious advantages
Improved innovation has obvious advantages For original research pharmaceutical companies that are in a leading position in a certain field, improved innovation can also form a certain period of market exclusivity, and companies can avoid the risk of original research patent cliffs through improvements.
For challengers, improved innovations can help companies avoid becoming victims in the "fight against imitations", and seek to borrow from the improvement of original research products.
For challengers, improved innovations can help companies avoid becoming victims in the "fight against imitations", and seek to borrow from the improvement of original research products.
Compared with the development of innovative drugs, improved new drugs have the characteristics of low investment and low risk.
At the same time, thanks to the successful experience of the original research drug market, the improved new drugs have higher clinical acceptance and faster profit returns.
The author believes that improved innovation will become the golden track for the next round of transition from Chinese pharmaceutical companies to innovative pharmaceutical companies.
At the same time, thanks to the successful experience of the original research drug market, the improved new drugs have higher clinical acceptance and faster profit returns.
The author believes that improved innovation will become the golden track for the next round of transition from Chinese pharmaceutical companies to innovative pharmaceutical companies.
