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Medical Network News, June 18 With the normalization of centralized procurement, the competitive pressure of ordinary preparations has increased, and high-tech and high-barrier high-end preparations can be regarded as an innovative "shortcut"
.
Compared with ordinary generic drugs, high-end formulations have high R&D process and market entry barriers, and fewer competing products; compared with innovative drugs, high-end formulations have a shorter R&D cycle, which can effectively save R&D costs and reduce R&D risks
.
The "13th Five-Year Plan" proposes to focus on the development of new drug delivery systems such as liposomes, lipid microspheres, and nano preparations.
In China, many high-end preparations have become "explosive models" in sales.
Many companies rushed to run liposomes and microbes.
ball, orally disintegrating film, inhalants, micelles, nanoparticles, etc.
gold formulations end track, comprising SPG, Qilu, Franc, leaves, Henry like
.
.
Compared with ordinary generic drugs, high-end formulations have high R&D process and market entry barriers, and fewer competing products; compared with innovative drugs, high-end formulations have a shorter R&D cycle, which can effectively save R&D costs and reduce R&D risks
.
The "13th Five-Year Plan" proposes to focus on the development of new drug delivery systems such as liposomes, lipid microspheres, and nano preparations.
In China, many high-end preparations have become "explosive models" in sales.
Many companies rushed to run liposomes and microbes.
ball, orally disintegrating film, inhalants, micelles, nanoparticles, etc.
gold formulations end track, comprising SPG, Qilu, Franc, leaves, Henry like
.
Two liposome preparations exceed 2 billion, with CSPC and Luye leading the way
Liposome preparations approved in China
Source: Mi Nei.
com, China's public medical institutions terminal competition pattern
com, China's public medical institutions terminal competition pattern
Liposome preparations are micro-vesicles formed by encapsulating drugs in lipid bilayers.
They have the characteristics of strong targeting, high safety, good slow-release effect, and high biocompatibility.
They are considered to be One of the most promising injection dosage forms at present
.
They have the characteristics of strong targeting, high safety, good slow-release effect, and high biocompatibility.
They are considered to be One of the most promising injection dosage forms at present
.
At present, a variety of liposome preparations have been approved for marketing in China.
Doxorubicin Hydrochloride Liposome Injection and Paclitaxel Liposome for Injection will be used in urban public hospitals , county-level public hospitals, urban community centers and township health centers in China in 2020.
The terminal sales of the hospital (referred to as China's public medical institutions) have exceeded 2 billion yuan, of which paclitaxel liposomes for injection are Luye Pharma’s exclusive products (including exclusive formulations, the same below)
.
Doxorubicin Hydrochloride Liposome Injection and Paclitaxel Liposome for Injection will be used in urban public hospitals , county-level public hospitals, urban community centers and township health centers in China in 2020.
The terminal sales of the hospital (referred to as China's public medical institutions) have exceeded 2 billion yuan, of which paclitaxel liposomes for injection are Luye Pharma’s exclusive products (including exclusive formulations, the same below)
.
Domestic liposome preparations under development
Source: China Drug Clinical Trial Publicity Library of Meinenet
Domestic research and development of liposome preparations is relatively hot, including bupivacaine liposome injection, amphotericin B liposome for injection, mitoxantrone hydrochloride liposome injection, and irinotecan hydrochloride liposome Injection, alprostadil liposome for injection, docetaxel liposome for injection, doxorubicin hydrochloride liposome injection, etc.
Among them, irinotecan hydrochloride liposome injection is highly competitive, Hengrui, Six companies including CSPC and Luye competed for the first in the country
.
Among them, irinotecan hydrochloride liposome injection is highly competitive, Hengrui, Six companies including CSPC and Luye competed for the first in the country
.
In terms of the status of enterprise declarations, CSPC leads the way.
One product has been approved, two have been submitted for production, and four have been approved for clinical trials or are undergoing clinical trials; Luye Pharma also has one product approved and five products have been approved.
Approved for clinical trials or are in clinical development
.
One product has been approved, two have been submitted for production, and four have been approved for clinical trials or are undergoing clinical trials; Luye Pharma also has one product approved and five products have been approved.
Approved for clinical trials or are in clinical development
.
3 domestic microsphere preparations were approved, with Livzon and Luye leading the way
Some domestic approved microsphere preparations
Source: Mi Nei.
com, China's public medical institutions terminal competition pattern
com, China's public medical institutions terminal competition pattern
Microspheres are tiny spherical entities with a particle size of about 1-250 microns that are dispersed and embedded in a polymer matrix through microencapsulation technology
.
The microsphere preparation can not only prolong the action time of the drug, improve the drug effect, but also greatly reduce the number of times the patient is administered, and improve the convenience and compliance of the patient's medication
.
.
The microsphere preparation can not only prolong the action time of the drug, improve the drug effect, but also greatly reduce the number of times the patient is administered, and improve the convenience and compliance of the patient's medication
.
Among the domestically marketed microsphere preparations, the sales of leuprorelin acetate sustained-release microspheres for injection and leuprolide acetate microspheres for injection in China's public medical institutions in 2020 will each exceed 1 billion yuan
.
.
Domestic microsphere preparations under development
Source: China Drug Clinical Trial Publicity Library of Meinenet
The microsphere preparation market has a bright future, which has attracted many companies to deploy
.
At present, the microsphere preparations declared by domestic enterprises mainly include rotigotine sustained-release microspheres for injection, triptorelin acetate microspheres for injection, goserelin acetate sustained-release microspheres for injection, and triptore acetate acetate for injection parylene sustained release microspheres, injectable octreotide acetate microspheres, injectable Alarelin release microspheres and the like
.
.
At present, the microsphere preparations declared by domestic enterprises mainly include rotigotine sustained-release microspheres for injection, triptorelin acetate microspheres for injection, goserelin acetate sustained-release microspheres for injection, and triptore acetate acetate for injection parylene sustained release microspheres, injectable octreotide acetate microspheres, injectable Alarelin release microspheres and the like
.
The main applicant companies include Luye, Livzon, Changchun Jinsai, Qilu, Anhui Fengyuan Pharmaceutical, etc.
Among them, Livzon and Luye are the leaders.
Both companies have 1 product approved, and 5 have been approved for clinical trials or are in clinical trials.
.
Among them, Livzon and Luye are the leaders.
Both companies have 1 product approved, and 5 have been approved for clinical trials or are in clinical trials.
.
Domestic substitution of inhalants is underway, with Healthyuan and Chengdu Beite leading the way
Inhalants have obvious clinical advantages
.
Compared with oral agents, inhalants can directly reach the absorption or action site, with quick onset and avoid the liver first-pass effect; compared with intramuscular injection, intravenous drip, etc.
, inhalants have fast onset, good curative effect, and systemic maladies.
There are many advantages such as less reaction and easy administration
.
.
Compared with oral agents, inhalants can directly reach the absorption or action site, with quick onset and avoid the liver first-pass effect; compared with intramuscular injection, intravenous drip, etc.
, inhalants have fast onset, good curative effect, and systemic maladies.
There are many advantages such as less reaction and easy administration
.
In 2020, China's public medical institutions will terminal over 1 billion inhalants
Source: Mi Nei.
com, China's public medical institutions terminal competition pattern
com, China's public medical institutions terminal competition pattern
Compared with other high-end preparations, the domestic market for inhalants is relatively mature.
In recent years, as more and more domestic inhalants have been approved for marketing, the market share of imported inhalants has gradually been eroded
.
The sales of five inhalants in China's public medical institutions will exceed 1 billion yuan in 2020, and Hengrui will dominate the market for sevoflurane for inhalation
.
In recent years, as more and more domestic inhalants have been approved for marketing, the market share of imported inhalants has gradually been eroded
.
The sales of five inhalants in China's public medical institutions will exceed 1 billion yuan in 2020, and Hengrui will dominate the market for sevoflurane for inhalation
.
At present, more than 100 domestic inhalants ( counted by the name of the drug + the name of the declared company ) have been reported for production under the new registration classification.
From the perspective of the competition of varieties, ambroxol hydrochloride inhalation solution, compound ipratropium bromide inhalation solution, isopropyl The competition for tropium bromide inhalation solution, salbutamol sulfate solution for inhalation, and terbutaline sulfate inhalation solution for nebulization is fierce.
Among them, nearly 20 companies for ambroxol hydrochloride inhalation solution have been submitted for production under the new classification, and 2 companies have successfully obtained Batch production is regarded as over-rated
.
From the perspective of the competition of varieties, ambroxol hydrochloride inhalation solution, compound ipratropium bromide inhalation solution, isopropyl The competition for tropium bromide inhalation solution, salbutamol sulfate solution for inhalation, and terbutaline sulfate inhalation solution for nebulization is fierce.
Among them, nearly 20 companies for ambroxol hydrochloride inhalation solution have been submitted for production under the new classification, and 2 companies have successfully obtained Batch production is regarded as over-rated
.
From the companies reporting situation, health yuan, involving a few more varieties of four Trump SNS (Chengdu Brilliant subsidiaries), Chia Tai Pharmaceutical, Hebei Yikang of benevolence, Changfeng medicine, Henry and other enterprises, including health Yuan and Sichuan Prime have reported that 10 or more inhalants have been produced
.
.
3 oral membrane preparations were approved, Qilu and Hengrui led the way
Oral fast-dissolving film preparation refers to a film-like preparation made by processing medicines and suitable film-forming materials for oral or mucosal use.
It has convenient administration, accurate dosage, stable quality, convenient carrying, and is suitable for children, the elderly, and emergency use.
Advantages
.
At present, 3 types of oral dissolving membranes have been approved for marketing in China, namely Qilu's Olanzapine Oral Dissolving Membrane and Montelukast Sodium Oral Dissolving Membrane, and Hausen's Olanzapine Oral Dissolving Membrane.
None of the three products will be produced in 2020.
Sales
.
It has convenient administration, accurate dosage, stable quality, convenient carrying, and is suitable for children, the elderly, and emergency use.
Advantages
.
At present, 3 types of oral dissolving membranes have been approved for marketing in China, namely Qilu's Olanzapine Oral Dissolving Membrane and Montelukast Sodium Oral Dissolving Membrane, and Hausen's Olanzapine Oral Dissolving Membrane.
None of the three products will be produced in 2020.
Sales
.
Domestic oral membrane preparations under development
Source: China Drug Clinical Trial Publicity Library of Meinenet
The oral dissolving film preparations currently registered in China include memantine hydrochloride oral dissolving film, ondansetron oral dissolving film, tadalafil oral dissolving film, aripiprazole oral dissolving film, and donepezil hydrochloride oral dissolving film, etc.
tadalafil orally disintegrating film more intense competition; indications involved include erectile dysfunction, Alzheimer's disease, schizophrenia and so on
.
tadalafil orally disintegrating film more intense competition; indications involved include erectile dysfunction, Alzheimer's disease, schizophrenia and so on
.
The main application companies include Qilu, Hengrui, Lipin Pharmaceutical, Kelun Pharmaceutical, etc.
Qilu 2 products have been approved, 3 products have been submitted for production, and 3 products have been approved for clinical use; Hengrui has no products approved for the time being , But one product has been submitted for production, one product has completed the BE test, and two products have been approved for clinical use
.
Qilu 2 products have been approved, 3 products have been submitted for production, and 3 products have been approved for clinical use; Hengrui has no products approved for the time being , But one product has been submitted for production, one product has completed the BE test, and two products have been approved for clinical use
.
Micellar preparations are widely used in anti-tumor drugs, and the development of these two products is hot
Micellar preparations have the advantages of solubilizing poorly soluble drugs, improving bioavailability, targeting, EPR effect, etc.
, and are widely used in anti-tumor drugs
.
At present, no micellar preparations have been approved in China, but there are already many companies
.
, and are widely used in anti-tumor drugs
.
At present, no micellar preparations have been approved in China, but there are already many companies
.
Domestic micellar preparations under development
Source: China Drug Clinical Trial Publicity Library of Meinenet
At present, there are not many types of micellar preparations registered and declared in China.
There are many companies applying for paclitaxel polymer micelles for injection and docetaxel polymer micelles for injection.
Both paclitaxel and docetaxel belong to taxane antibiotics.
For oncology drugs, its early marketed preparations need to be solubilized with surfactants, and there are serious adverse reactions.
The development of new pharmaceutical preparations such as liposomes, micelles, albumin-binding, and nanoparticles can solve this problem
.
There are many companies applying for paclitaxel polymer micelles for injection and docetaxel polymer micelles for injection.
Both paclitaxel and docetaxel belong to taxane antibiotics.
For oncology drugs, its early marketed preparations need to be solubilized with surfactants, and there are serious adverse reactions.
The development of new pharmaceutical preparations such as liposomes, micelles, albumin-binding, and nanoparticles can solve this problem
.
The domestic nano preparation market is blank, and the research and development progress is relatively slow
Nanoparticles are solid drug-carrying colloidal particles with natural or synthetic polymer materials as carriers, with a general particle size of 10-1000nm
.
Nanoparticles have passive targeting to liver, spleen, bone marrow and other parts, can be used as a carrier of anticancer drugs, and can also improve the therapeutic effect of antibiotics and antiviral drugs
.
.
Nanoparticles have passive targeting to liver, spleen, bone marrow and other parts, can be used as a carrier of anticancer drugs, and can also improve the therapeutic effect of antibiotics and antiviral drugs
.
Domestic nano-formulations under development
Source: China Drug Clinical Trial Publicity Library of Meinenet
At present, there are not many types of nano preparations under research in China, mainly including fenofibrate tablets, docetaxel nanoparticles for injection, amphotericin B composite phospholipid nanoliposomes for injection, and irinotecan hydrochloride nanogel for injection beam, like paclitaxel injection nanoparticles
.
.
Source: Mi Nei Net Database
Medical Network News, June 18 With the normalization of centralized procurement, the competitive pressure of ordinary preparations has increased, and high-tech and high-barrier high-end preparations can be regarded as an innovative "shortcut"
.
Compared with ordinary generic drugs, high-end formulations have high R&D process and market entry barriers, and fewer competing products; compared with innovative drugs, high-end formulations have a shorter R&D cycle, which can effectively save R&D costs and reduce R&D risks
.
The "13th Five-Year Plan" proposes to focus on the development of new drug delivery systems such as liposomes, lipid microspheres, and nano preparations.
In China, many high-end preparations have become "explosive models" in sales.
Many companies rushed to run liposomes and microbes.
ball, orally disintegrating film, inhalants, micelles, nanoparticles, etc.
gold formulations end track, comprising SPG, Qilu, Franc, leaves, Henry like
.
.
Compared with ordinary generic drugs, high-end formulations have high R&D process and market entry barriers, and fewer competing products; compared with innovative drugs, high-end formulations have a shorter R&D cycle, which can effectively save R&D costs and reduce R&D risks
.
The "13th Five-Year Plan" proposes to focus on the development of new drug delivery systems such as liposomes, lipid microspheres, and nano preparations.
In China, many high-end preparations have become "explosive models" in sales.
Many companies rushed to run liposomes and microbes.
ball, orally disintegrating film, inhalants, micelles, nanoparticles, etc.
gold formulations end track, comprising SPG, Qilu, Franc, leaves, Henry like
.
Two liposome preparations exceed 2 billion, with CSPC and Luye leading the way
Liposome preparations approved in China
Source: Mi Nei.
com, China's public medical institutions terminal competition pattern
com, China's public medical institutions terminal competition pattern
Liposome preparations are micro-vesicles formed by encapsulating drugs in lipid bilayers.
They have the characteristics of strong targeting, high safety, good slow-release effect, and high biocompatibility.
They are considered to be One of the most promising injection dosage forms at present
.
They have the characteristics of strong targeting, high safety, good slow-release effect, and high biocompatibility.
They are considered to be One of the most promising injection dosage forms at present
.
At present, a variety of liposome preparations have been approved for marketing in China.
Doxorubicin Hydrochloride Liposome Injection and Paclitaxel Liposome for Injection will be used in urban public hospitals , county-level public hospitals, urban community centers and township health centers in China in 2020.
The terminal sales of the hospital (referred to as China's public medical institutions) have exceeded 2 billion yuan, of which paclitaxel liposomes for injection are Luye Pharma’s exclusive products (including exclusive formulations, the same below)
.
Doxorubicin Hydrochloride Liposome Injection and Paclitaxel Liposome for Injection will be used in urban public hospitals , county-level public hospitals, urban community centers and township health centers in China in 2020.
The terminal sales of the hospital (referred to as China's public medical institutions) have exceeded 2 billion yuan, of which paclitaxel liposomes for injection are Luye Pharma’s exclusive products (including exclusive formulations, the same below)
.
Domestic liposome preparations under development
Source: China Drug Clinical Trial Publicity Library of Meinenet
Domestic research and development of liposome preparations is relatively hot, including bupivacaine liposome injection, amphotericin B liposome for injection, mitoxantrone hydrochloride liposome injection, and irinotecan hydrochloride liposome Injection, alprostadil liposome for injection, docetaxel liposome for injection, doxorubicin hydrochloride liposome injection, etc.
Among them, irinotecan hydrochloride liposome injection is highly competitive, Hengrui, Six companies including CSPC and Luye competed for the first in the country
.
Among them, irinotecan hydrochloride liposome injection is highly competitive, Hengrui, Six companies including CSPC and Luye competed for the first in the country
.
In terms of the status of enterprise declarations, CSPC leads the way.
One product has been approved, two have been submitted for production, and four have been approved for clinical trials or are undergoing clinical trials; Luye Pharma also has one product approved and five products have been approved.
Approved for clinical trials or are in clinical development
.
One product has been approved, two have been submitted for production, and four have been approved for clinical trials or are undergoing clinical trials; Luye Pharma also has one product approved and five products have been approved.
Approved for clinical trials or are in clinical development
.
3 domestic microsphere preparations were approved, with Livzon and Luye leading the way
Some domestic approved microsphere preparations
Source: Mi Nei.
com, China's public medical institutions terminal competition pattern
com, China's public medical institutions terminal competition pattern
Microspheres are tiny spherical entities with a particle size of about 1-250 microns that are dispersed and embedded in a polymer matrix through microencapsulation technology
.
The microsphere preparation can not only prolong the action time of the drug, improve the drug effect, but also greatly reduce the number of times the patient is administered, and improve the convenience and compliance of the patient's medication
.
.
The microsphere preparation can not only prolong the action time of the drug, improve the drug effect, but also greatly reduce the number of times the patient is administered, and improve the convenience and compliance of the patient's medication
.
Among the domestically marketed microsphere preparations, the sales of leuprorelin acetate sustained-release microspheres for injection and leuprolide acetate microspheres for injection in China's public medical institutions in 2020 will each exceed 1 billion yuan
.
.
Domestic microsphere preparations under development
Source: China Drug Clinical Trial Publicity Library of Meinenet
The microsphere preparation market has a bright future, which has attracted many companies to deploy
.
At present, the microsphere preparations declared by domestic enterprises mainly include rotigotine sustained-release microspheres for injection, triptorelin acetate microspheres for injection, goserelin acetate sustained-release microspheres for injection, and triptore acetate acetate for injection parylene sustained release microspheres, injectable octreotide acetate microspheres, injectable Alarelin release microspheres and the like
.
.
At present, the microsphere preparations declared by domestic enterprises mainly include rotigotine sustained-release microspheres for injection, triptorelin acetate microspheres for injection, goserelin acetate sustained-release microspheres for injection, and triptore acetate acetate for injection parylene sustained release microspheres, injectable octreotide acetate microspheres, injectable Alarelin release microspheres and the like
.
The main applicant companies include Luye, Livzon, Changchun Jinsai, Qilu, Anhui Fengyuan Pharmaceutical, etc.
Among them, Livzon and Luye are the leaders.
Both companies have 1 product approved, and 5 have been approved for clinical trials or are in clinical trials.
.
Among them, Livzon and Luye are the leaders.
Both companies have 1 product approved, and 5 have been approved for clinical trials or are in clinical trials.
.
Domestic substitution of inhalants is underway, with Healthyuan and Chengdu Beite leading the way
Inhalants have obvious clinical advantages
.
Compared with oral agents, inhalants can directly reach the absorption or action site, with quick onset and avoid the liver first-pass effect; compared with intramuscular injection, intravenous drip, etc.
, inhalants have fast onset, good curative effect, and systemic maladies.
There are many advantages such as less reaction and easy administration
.
.
Compared with oral agents, inhalants can directly reach the absorption or action site, with quick onset and avoid the liver first-pass effect; compared with intramuscular injection, intravenous drip, etc.
, inhalants have fast onset, good curative effect, and systemic maladies.
There are many advantages such as less reaction and easy administration
.
In 2020, China's public medical institutions will terminal over 1 billion inhalants
Source: Mi Nei.
com, China's public medical institutions terminal competition pattern
com, China's public medical institutions terminal competition pattern
Compared with other high-end preparations, the domestic market for inhalants is relatively mature.
In recent years, as more and more domestic inhalants have been approved for marketing, the market share of imported inhalants has gradually been eroded
.
The sales of five inhalants in China's public medical institutions will exceed 1 billion yuan in 2020, and Hengrui will dominate the market for sevoflurane for inhalation
.
In recent years, as more and more domestic inhalants have been approved for marketing, the market share of imported inhalants has gradually been eroded
.
The sales of five inhalants in China's public medical institutions will exceed 1 billion yuan in 2020, and Hengrui will dominate the market for sevoflurane for inhalation
.
At present, more than 100 domestic inhalants ( counted by the name of the drug + the name of the declared company ) have been reported for production under the new registration classification.
From the perspective of the competition of varieties, ambroxol hydrochloride inhalation solution, compound ipratropium bromide inhalation solution, isopropyl The competition for tropium bromide inhalation solution, salbutamol sulfate solution for inhalation, and terbutaline sulfate inhalation solution for nebulization is fierce.
Among them, nearly 20 companies for ambroxol hydrochloride inhalation solution have been submitted for production under the new classification, and 2 companies have successfully obtained Batch production is regarded as over-rated
.
From the perspective of the competition of varieties, ambroxol hydrochloride inhalation solution, compound ipratropium bromide inhalation solution, isopropyl The competition for tropium bromide inhalation solution, salbutamol sulfate solution for inhalation, and terbutaline sulfate inhalation solution for nebulization is fierce.
Among them, nearly 20 companies for ambroxol hydrochloride inhalation solution have been submitted for production under the new classification, and 2 companies have successfully obtained Batch production is regarded as over-rated
.
From the companies reporting situation, health yuan, involving a few more varieties of four Trump SNS (Chengdu Brilliant subsidiaries), Chia Tai Pharmaceutical, Hebei Yikang of benevolence, Changfeng medicine, Henry and other enterprises, including health Yuan and Sichuan Prime have reported that 10 or more inhalants have been produced
.
.
3 oral membrane preparations were approved, Qilu and Hengrui led the way
Oral fast-dissolving film preparation refers to a film-like preparation made by processing medicines and suitable film-forming materials for oral or mucosal use.
It has convenient administration, accurate dosage, stable quality, convenient carrying, and is suitable for children, the elderly, and emergency use.
Advantages
.
At present, 3 types of oral dissolving membranes have been approved for marketing in China, namely Qilu's Olanzapine Oral Dissolving Membrane and Montelukast Sodium Oral Dissolving Membrane, and Hausen's Olanzapine Oral Dissolving Membrane.
None of the three products will be produced in 2020.
Sales
.
It has convenient administration, accurate dosage, stable quality, convenient carrying, and is suitable for children, the elderly, and emergency use.
Advantages
.
At present, 3 types of oral dissolving membranes have been approved for marketing in China, namely Qilu's Olanzapine Oral Dissolving Membrane and Montelukast Sodium Oral Dissolving Membrane, and Hausen's Olanzapine Oral Dissolving Membrane.
None of the three products will be produced in 2020.
Sales
.
Domestic oral membrane preparations under development
Source: China Drug Clinical Trial Publicity Library of Meinenet
The oral dissolving film preparations currently registered in China include memantine hydrochloride oral dissolving film, ondansetron oral dissolving film, tadalafil oral dissolving film, aripiprazole oral dissolving film, and donepezil hydrochloride oral dissolving film, etc.
tadalafil orally disintegrating film more intense competition; indications involved include erectile dysfunction, Alzheimer's disease, schizophrenia and so on
.
tadalafil orally disintegrating film more intense competition; indications involved include erectile dysfunction, Alzheimer's disease, schizophrenia and so on
.
The main application companies include Qilu, Hengrui, Lipin Pharmaceutical, Kelun Pharmaceutical, etc.
Qilu 2 products have been approved, 3 products have been submitted for production, and 3 products have been approved for clinical use; Hengrui has no products approved for the time being , But one product has been submitted for production, one product has completed the BE test, and two products have been approved for clinical use
.
Qilu 2 products have been approved, 3 products have been submitted for production, and 3 products have been approved for clinical use; Hengrui has no products approved for the time being , But one product has been submitted for production, one product has completed the BE test, and two products have been approved for clinical use
.
Micellar preparations are widely used in anti-tumor drugs, and the development of these two products is hot
Micellar preparations have the advantages of solubilizing poorly soluble drugs, improving bioavailability, targeting, EPR effect, etc.
, and are widely used in anti-tumor drugs
.
At present, no micellar preparations have been approved in China, but there are already many companies
.
, and are widely used in anti-tumor drugs
.
At present, no micellar preparations have been approved in China, but there are already many companies
.
Domestic micellar preparations under development
Source: China Drug Clinical Trial Publicity Library of Meinenet
At present, there are not many types of micellar preparations registered and declared in China.
There are many companies applying for paclitaxel polymer micelles for injection and docetaxel polymer micelles for injection.
Both paclitaxel and docetaxel belong to taxane antibiotics.
For oncology drugs, its early marketed preparations need to be solubilized with surfactants, and there are serious adverse reactions.
The development of new pharmaceutical preparations such as liposomes, micelles, albumin-binding, and nanoparticles can solve this problem
.
There are many companies applying for paclitaxel polymer micelles for injection and docetaxel polymer micelles for injection.
Both paclitaxel and docetaxel belong to taxane antibiotics.
For oncology drugs, its early marketed preparations need to be solubilized with surfactants, and there are serious adverse reactions.
The development of new pharmaceutical preparations such as liposomes, micelles, albumin-binding, and nanoparticles can solve this problem
.
The domestic nano preparation market is blank, and the research and development progress is relatively slow
Nanoparticles are solid drug-carrying colloidal particles with natural or synthetic polymer materials as carriers, with a general particle size of 10-1000nm
.
Nanoparticles have passive targeting to liver, spleen, bone marrow and other parts, can be used as a carrier of anticancer drugs, and can also improve the therapeutic effect of antibiotics and antiviral drugs
.
.
Nanoparticles have passive targeting to liver, spleen, bone marrow and other parts, can be used as a carrier of anticancer drugs, and can also improve the therapeutic effect of antibiotics and antiviral drugs
.
Domestic nano-formulations under development
Source: China Drug Clinical Trial Publicity Library of Meinenet
At present, there are not many types of nano preparations under research in China, mainly including fenofibrate tablets, docetaxel nanoparticles for injection, amphotericin B composite phospholipid nanoliposomes for injection, and irinotecan hydrochloride nanogel for injection beam, like paclitaxel injection nanoparticles
.
.
Source: Mi Nei Net Database
Medical Network News, June 18 With the normalization of centralized procurement, the competitive pressure of ordinary preparations has increased, and high-tech and high-barrier high-end preparations can be regarded as an innovative "shortcut"
.
Compared with ordinary generic drugs, high-end formulations have high R&D process and market entry barriers, and fewer competing products; compared with innovative drugs, high-end formulations have a shorter R&D cycle, which can effectively save R&D costs and reduce R&D risks
.
The "13th Five-Year Plan" proposes to focus on the development of new drug delivery systems such as liposomes, lipid microspheres, and nano preparations.
In China, many high-end preparations have become "explosive models" in sales.
Many companies rushed to run liposomes and microbes.
ball, orally disintegrating film, inhalants, micelles, nanoparticles, etc.
gold formulations end track, comprising SPG, Qilu, Franc, leaves, Henry like
.
.
Compared with ordinary generic drugs, high-end formulations have high R&D process and market entry barriers, and fewer competing products; compared with innovative drugs, high-end formulations have a shorter R&D cycle, which can effectively save R&D costs and reduce R&D risks
.
The "13th Five-Year Plan" proposes to focus on the development of new drug delivery systems such as liposomes, lipid microspheres, and nano preparations.
In China, many high-end preparations have become "explosive models" in sales.
Many companies rushed to run liposomes and microbes.
ball, orally disintegrating film, inhalants, micelles, nanoparticles, etc.
gold formulations end track, comprising SPG, Qilu, Franc, leaves, Henry like
.
Two liposome preparations exceed 2 billion, with CSPC and Luye leading the way
Two liposome preparations exceed 2 billion, with CSPC and Luye leading the way Liposome preparations approved in China
Source: Mi Nei.
com, China's public medical institutions terminal competition pattern
com, China's public medical institutions terminal competition pattern
Liposome preparations are micro-vesicles formed by encapsulating drugs in lipid bilayers.
They have the characteristics of strong targeting, high safety, good slow-release effect, and high biocompatibility.
They are considered to be One of the most promising injection dosage forms at present
.
They have the characteristics of strong targeting, high safety, good slow-release effect, and high biocompatibility.
They are considered to be One of the most promising injection dosage forms at present
.
At present, a variety of liposome preparations have been approved for marketing in China.
Doxorubicin Hydrochloride Liposome Injection and Paclitaxel Liposome for Injection will be used in urban public hospitals , county-level public hospitals, urban community centers and township health centers in China in 2020.
The terminal sales of the hospital (referred to as China's public medical institutions) have exceeded 2 billion yuan, of which paclitaxel liposomes for injection are Luye Pharma’s exclusive products (including exclusive formulations, the same below)
.
Hospital hospital hospitalDoxorubicin Hydrochloride Liposome Injection and Paclitaxel Liposome for Injection will be used in urban public hospitals , county-level public hospitals, urban community centers and township health centers in China in 2020.
The terminal sales of the hospital (referred to as China's public medical institutions) have exceeded 2 billion yuan, of which paclitaxel liposomes for injection are Luye Pharma’s exclusive products (including exclusive formulations, the same below)
.
Domestic liposome preparations under development
Source: China Drug Clinical Trial Publicity Library of Meinenet
Domestic research and development of liposome preparations is relatively hot, including bupivacaine liposome injection, amphotericin B liposome for injection, mitoxantrone hydrochloride liposome injection, and irinotecan hydrochloride liposome Injection, alprostadil liposome for injection, docetaxel liposome for injection, doxorubicin hydrochloride liposome injection, etc.
Among them, irinotecan hydrochloride liposome injection is highly competitive, Hengrui, Six companies including CSPC and Luye competed for the first in the country
.
Among them, irinotecan hydrochloride liposome injection is highly competitive, Hengrui, Six companies including CSPC and Luye competed for the first in the country
.
In terms of the status of enterprise declarations, CSPC leads the way.
One product has been approved, two have been submitted for production, and four have been approved for clinical trials or are undergoing clinical trials; Luye Pharma also has one product approved and five products have been approved.
Approved for clinical trials or are in clinical development
.
One product has been approved, two have been submitted for production, and four have been approved for clinical trials or are undergoing clinical trials; Luye Pharma also has one product approved and five products have been approved.
Approved for clinical trials or are in clinical development
.
3 domestic microsphere preparations were approved, with Livzon and Luye leading the way
3 domestic microsphere preparations were approved, with Livzon and Luye leading the way Some domestic approved microsphere preparations
Source: Mi Nei.
com, China's public medical institutions terminal competition pattern
com, China's public medical institutions terminal competition pattern
Microspheres are tiny spherical entities with a particle size of about 1-250 microns that are dispersed and embedded in a polymer matrix through microencapsulation technology
.
The microsphere preparation can not only prolong the action time of the drug, improve the drug effect, but also greatly reduce the number of times the patient is administered, and improve the convenience and compliance of the patient's medication
.
.
The microsphere preparation can not only prolong the action time of the drug, improve the drug effect, but also greatly reduce the number of times the patient is administered, and improve the convenience and compliance of the patient's medication
.
Among the domestically marketed microsphere preparations, the sales of leuprorelin acetate sustained-release microspheres for injection and leuprolide acetate microspheres for injection in China's public medical institutions in 2020 will each exceed 1 billion yuan
.
.
Domestic microsphere preparations under development
Source: China Drug Clinical Trial Publicity Library of Meinenet
The microsphere preparation market has a bright future, which has attracted many companies to deploy
.
At present, the microsphere preparations declared by domestic enterprises mainly include rotigotine sustained-release microspheres for injection, triptorelin acetate microspheres for injection, goserelin acetate sustained-release microspheres for injection, and triptore acetate acetate for injection parylene sustained release microspheres, injectable octreotide acetate microspheres, injectable Alarelin release microspheres and the like
.
.
At present, the microsphere preparations declared by domestic enterprises mainly include rotigotine sustained-release microspheres for injection, triptorelin acetate microspheres for injection, goserelin acetate sustained-release microspheres for injection, and triptore acetate acetate for injection parylene sustained release microspheres, injectable octreotide acetate microspheres, injectable Alarelin release microspheres and the like
.
The main applicant companies include Luye, Livzon, Changchun Jinsai, Qilu, Anhui Fengyuan Pharmaceutical, etc.
Among them, Livzon and Luye are the leaders.
Both companies have 1 product approved, and 5 have been approved for clinical trials or are in clinical trials.
.
Among them, Livzon and Luye are the leaders.
Both companies have 1 product approved, and 5 have been approved for clinical trials or are in clinical trials.
.
Domestic substitution of inhalants is underway, with Healthyuan and Chengdu Beite leading the way
Domestic substitution of inhalants is underway, with Healthyuan and Chengdu Beite leading the way Inhalants have obvious clinical advantages
.
Compared with oral agents, inhalants can directly reach the absorption or action site, with quick onset and avoid the liver first-pass effect; compared with intramuscular injection, intravenous drip, etc.
, inhalants have fast onset, good curative effect, and systemic maladies.
There are many advantages such as less reaction and easy administration
.
Adverse reactions adverse reactions adverse reactions.
Compared with oral agents, inhalants can directly reach the absorption or action site, with quick onset and avoid the liver first-pass effect; compared with intramuscular injection, intravenous drip, etc.
, inhalants have fast onset, good curative effect, and systemic maladies.
There are many advantages such as less reaction and easy administration
.
In 2020, China's public medical institutions will terminal over 1 billion inhalants
Source: Mi Nei.
com, China's public medical institutions terminal competition pattern
com, China's public medical institutions terminal competition pattern
Compared with other high-end preparations, the domestic market for inhalants is relatively mature.
In recent years, as more and more domestic inhalants have been approved for marketing, the market share of imported inhalants has gradually been eroded
.
The sales of five inhalants in China's public medical institutions will exceed 1 billion yuan in 2020, and Hengrui will dominate the market for sevoflurane for inhalation
.
In recent years, as more and more domestic inhalants have been approved for marketing, the market share of imported inhalants has gradually been eroded
.
The sales of five inhalants in China's public medical institutions will exceed 1 billion yuan in 2020, and Hengrui will dominate the market for sevoflurane for inhalation
.
At present, more than 100 domestic inhalants ( counted by the name of the drug + the name of the declared company ) have been reported for production under the new registration classification.
From the perspective of the competition of varieties, ambroxol hydrochloride inhalation solution, compound ipratropium bromide inhalation solution, isopropyl The competition for tropium bromide inhalation solution, salbutamol sulfate solution for inhalation, and terbutaline sulfate inhalation solution for nebulization is fierce.
Among them, nearly 20 companies for ambroxol hydrochloride inhalation solution have been submitted for production under the new classification, and 2 companies have successfully obtained Batch production is regarded as over-rated
.
Drugs Drugs Drugs enterprise business enterpriseFrom the perspective of the competition of varieties, ambroxol hydrochloride inhalation solution, compound ipratropium bromide inhalation solution, isopropyl The competition for tropium bromide inhalation solution, salbutamol sulfate solution for inhalation, and terbutaline sulfate inhalation solution for nebulization is fierce.
Among them, nearly 20 companies for ambroxol hydrochloride inhalation solution have been submitted for production under the new classification, and 2 companies have successfully obtained Batch production is regarded as over-rated
.
From the companies reporting situation, health yuan, involving a few more varieties of four Trump SNS (Chengdu Brilliant subsidiaries), Chia Tai Pharmaceutical, Hebei Yikang of benevolence, Changfeng medicine, Henry and other enterprises, including health Yuan and Sichuan Prime have reported that 10 or more inhalants have been produced
.
Healthy, healthy, healthy.
3 oral membrane preparations were approved, Qilu and Hengrui led the way
3 oral membrane preparations were approved, Qilu and Hengrui led the way Oral fast-dissolving film preparation refers to a film-like preparation made by processing medicines and suitable film-forming materials for oral or mucosal use.
It has convenient administration, accurate dosage, stable quality, convenient carrying, and is suitable for children, the elderly, and emergency use.
Advantages
.
At present, 3 types of oral dissolving membranes have been approved for marketing in China, namely Qilu's Olanzapine Oral Dissolving Membrane and Montelukast Sodium Oral Dissolving Membrane, and Hausen's Olanzapine Oral Dissolving Membrane.
None of the three products will be produced in 2020.
Sales
.
It has convenient administration, accurate dosage, stable quality, convenient carrying, and is suitable for children, the elderly, and emergency use.
Advantages
.
At present, 3 types of oral dissolving membranes have been approved for marketing in China, namely Qilu's Olanzapine Oral Dissolving Membrane and Montelukast Sodium Oral Dissolving Membrane, and Hausen's Olanzapine Oral Dissolving Membrane.
None of the three products will be produced in 2020.
Sales
.
Domestic oral membrane preparations under development
Source: China Drug Clinical Trial Publicity Library of Meinenet
The oral dissolving film preparations currently registered in China include memantine hydrochloride oral dissolving film, ondansetron oral dissolving film, tadalafil oral dissolving film, aripiprazole oral dissolving film, and donepezil hydrochloride oral dissolving film, etc.
tadalafil orally disintegrating film more intense competition; indications involved include erectile dysfunction, Alzheimer's disease, schizophrenia and so on
.
tadalafil orally disintegrating film more intense competition; indications involved include erectile dysfunction, Alzheimer's disease, schizophrenia and so on
.
The main application companies include Qilu, Hengrui, Lipin Pharmaceutical, Kelun Pharmaceutical, etc.
Qilu 2 products have been approved, 3 products have been submitted for production, and 3 products have been approved for clinical use; Hengrui has no products approved for the time being , But one product has been submitted for production, one product has completed the BE test, and two products have been approved for clinical use
.
Qilu 2 products have been approved, 3 products have been submitted for production, and 3 products have been approved for clinical use; Hengrui has no products approved for the time being , But one product has been submitted for production, one product has completed the BE test, and two products have been approved for clinical use
.
Micellar preparations are widely used in anti-tumor drugs, and the development of these two products is hot
Micellar preparations are widely used in anti-tumor drugs, and the development of these two products is hot Micellar preparations have the advantages of solubilizing poorly soluble drugs, improving bioavailability, targeting, EPR effect, etc.
, and are widely used in anti-tumor drugs
.
At present, no micellar preparations have been approved in China, but there are already many companies
.
, and are widely used in anti-tumor drugs
.
At present, no micellar preparations have been approved in China, but there are already many companies
.
Domestic micellar preparations under development
Source: China Drug Clinical Trial Publicity Library of Meinenet
At present, there are not many types of micellar preparations registered and declared in China.
There are many companies applying for paclitaxel polymer micelles for injection and docetaxel polymer micelles for injection.
Both paclitaxel and docetaxel belong to taxane antibiotics.
For oncology drugs, its early marketed preparations need to be solubilized with surfactants, and there are serious adverse reactions.
The development of new pharmaceutical preparations such as liposomes, micelles, albumin-binding, and nanoparticles can solve this problem
.
There are many companies applying for paclitaxel polymer micelles for injection and docetaxel polymer micelles for injection.
Both paclitaxel and docetaxel belong to taxane antibiotics.
For oncology drugs, its early marketed preparations need to be solubilized with surfactants, and there are serious adverse reactions.
The development of new pharmaceutical preparations such as liposomes, micelles, albumin-binding, and nanoparticles can solve this problem
.
The domestic nano preparation market is blank, and the research and development progress is relatively slow
The domestic nano preparation market is blank, and the research and development progress is relatively slow Nanoparticles are solid drug-carrying colloidal particles with natural or synthetic polymer materials as carriers, with a general particle size of 10-1000nm
.
Nanoparticles have passive targeting to liver, spleen, bone marrow and other parts, can be used as a carrier of anticancer drugs, and can also improve the therapeutic effect of antibiotics and antiviral drugs
.
.
Nanoparticles have passive targeting to liver, spleen, bone marrow and other parts, can be used as a carrier of anticancer drugs, and can also improve the therapeutic effect of antibiotics and antiviral drugs
.
Domestic nano-formulations under development
Source: China Drug Clinical Trial Publicity Library of Meinenet
At present, there are not many types of nano preparations under research in China, mainly including fenofibrate tablets, docetaxel nanoparticles for injection, amphotericin B composite phospholipid nanoliposomes for injection, and irinotecan hydrochloride nanogel for injection beam, like paclitaxel injection nanoparticles
.
.
Source: Mi Nei Net Database
