This kind of new medicine is about to explode!

1026，，12
。，，，201852（、），201914，20207，20218，
。，？？

 

14，

 

1：2018（）

：MED2.
0

 

201814，，5、4、3、1
。，2020、、（）（）9700，，
。

 

From the perspective of registration classification, there are 3 new drugs in category 2.
1 (structure improvement)
.
Levoornidazole is the levorotatory body of ornidazole.
Clinical studies have shown that the efficacy of levornidazole in anti-anaerobic infection is equivalent to ornidazole, the incidence of total adverse reactions is significantly reduced, and clinical application is safer
.
At the terminal of public medical institutions in China, ornidazole reached sales of more than 3 billion yuan in 2019, but the growth rate has been declining in recent years
.
At present, Levo Ornidazole Tablets and Levo Ornidazole Sodium Chloride Injection have been listed on the domestic market.
In 2018, the total sales of Levo Ornidazole Sodium Chloride Injection in China's public medical institutions exceeded 380 million yuan.
Levo Ornidazole Sodium Chloride Injection has entered the market.
In the 2020 National Medical Insurance Catalogue, the growth rate of 2021H1 will rebound, reaching 14%
.

 

Ozagrel is a thromboxane synthase inhibitor with anti-platelet aggregation and vasodilator effects
.
At present, related products on the domestic market involve ozagrel sodium and sodium chloride injection, ozagrel sodium glucose injection, ozagrel sodium injection, and ozagrel sodium for injection.
In 2013, the whole product was launched in Chinese public medical institutions.
Sales exceed 1 billion yuan
.
It is reported that the concentrated solution of ozagrel tromethamine for injection has good water solubility, strong long-term stability, and has clinical advantages
.

 

　　Figure 1: Sales of over 1 billion varieties (unit: 100 million yuan)

　　Source: Mi Nei Net Database

 

　　Class 2.
2 new drugs (formulation improvements) involve 10 products, of which new drugs developed around over 1 billion varieties of olanzapine, entecavir, montelukast, paclitaxel, and risperidone are particularly concerned
.

 

　　Oral dissolving membrane is a new drug delivery system, which has the advantages of small size, light weight, convenient taking, no first-pass effect, etc.
It is especially suitable for children , the elderly, and patients with dysphagia
.
Hausen’s olanzapine mouth-melting membrane was approved in 2020 and is the first in China.
Qilu was approved in 2021, and Qilu’s products are currently on sale in the retail market
.
Montelukast is used clinically for the prevention and long-term treatment of asthma in adults and children.
Qilu started the development of oral dissolving membrane in 2013.
Montelukast sodium oral dissolving membrane is the company's second approved listing.
Mouth-melting film, Qilu is currently the first domestically approved enterprise for this product
.

 

　　Entecavir is the first-line treatment for hepatitis B recommended by the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B" in China.
Chronic hepatitis B not only involves adult patients, but it will be more troublesome to deal with if children are sick
.
Entecavir granules from Hunan Warner Pharmaceutical Factory were included in the priority review on the grounds of "children's medicine" and children with hepatitis B have special medicines
.

 

　　Paclitaxel is the largest variety of anti-tumor drug plant alkaloids and other natural medicines.
The approved paclitaxel polymer micelle for injection is an innovative formulation of paclitaxel, which has strong in vivo stability and intratumoral drug The high sensitivity of release, clinical research results show that the objective response rate (ORR) of injection paclitaxel polymer micelles is significantly improved, and the progression-free survival (PFS) is significantly prolonged
.
It is worth noting that the polymer micelle of paclitaxel for injection is the core product of Shanghai Yizhong Pharmaceutical, which has successfully landed on the Sci-tech Innovation Board this year.
The breakthrough has also attracted investors' attention
.

 

　　Risperidone is a major antipsychotic drug.
Luye’s risperidone microspheres for injection (II) is a long-acting injection that is injected intramuscularly every two weeks.
The product can maintain clinically effective blood concentration during use.
The stability of the system improves the convenience of the clinical treatment process
.
Improved drug green groups mentioned, we must think of the company's exclusive products paclitaxel liposome for injection, in 2020, Chinese public medical institutions terminal antineoplastic agents Plant alkaloids and other natural medicines brand TOP20, an injection of paclitaxel fat green leaves Plasmid is at the top of the list.
With such good results, the industry is more confident in the market performance of risperidone microspheres (II) for injection
.

 

　　The cefotaxime sodium tazobactam for injection of Nanjing Youke Pharmaceutical is a new class 2.
3 drug (new compound preparation).
The new drug combines cefotaxime with the β-lactamase inhibitor tazobactam to strongly inhibit The activity of β-lactamase prevents the hydrolysis of cefotaxime, restores the original antibacterial activity and antibacterial spectrum of the antibacterial drug, and solves the unilateral resistance problem of the third-generation cephalosporin
.
In 2019, the sales of terminal cefotaxime in public medical institutions in China were at the level of 2 billion yuan, and the sales of another compound preparation, cefotaxime and sulbactam, exceeded 1 billion yuan.
The market potential of this new drug is promising
.

 

　　20 new drugs are ready to be launched, Qilu aggressively attacked mouth-melting membranes, Shiyao used liposomes, and Livzon microspheres attracted attention

 

　　Table 2: Status of improved new drugs that have been declared for marketing and under review since 2018 (excluding new indications)

　　Source: Meinenet MED2.
0 Chinese Drug Evaluation Database

 

　　Since 2018, there are 20 new class 2 chemical drugs that have been declared for marketing and are under review (according to product + company statistics), two of which are new compound preparations (class 2.
3 new drugs), of which Adapalene Clindamycin Hydrochloride Compound Gel For the treatment of acne vulgaris, it is more effective than single prescription
.
Among the other improved new drugs under review, the marketing application of Levoornidazole Dispersible Tablets and Levoornidazole Capsules of Warner Pharmaceuticals has now entered the "under review" status, which is expected to further expand the domestic Levoornidazole product line camp.

.

 

　　Qilu continues to aggressively attack the field of oral dissolving membranes.
In addition to the marketed olanzapine oral dissolving membranes and montelukast sodium oral dissolving membranes (the first in China), the tadalafil oral dissolving membranes and aripiprazole oral dissolving membranes are currently under review.
Memantine hydrochloride membrane and memantine hydrochloride mouth-melting membrane are expected to be the first in China
.
In 2020, at the terminal of public medical institutions in China, aripiprazole is a species exceeding 1 billion, and the sales of tadalafil and memantine exceed 100 million yuan and 600 million yuan respectively
.

 

　　Hengrui and Livzon are also developing new formulations for large varieties
.
Before the collection of dexmedetomidine, Hengrui had always been a leader in this product and had a certain brand foundation
.
With the price reduction of dexmedetomidine, the market demand has further expanded.
In 2020, the sales of this product in public medical institutions in China will be close to 4 billion yuan.
At present, the main dosage form is injection, while nasal spray has convenient use and low dose.
, Avoid liver first-pass effect, the absorption rate can be compared with intravenous administration and other advantages, can also be used for local and systemic drugs, the potential after the market is worth looking forward to
.

 

　　Livzon has been deeply involved in the field of microspheres for many years, and currently has over 1 billion products of leuprorelin acetate microspheres for injection, and triptorelin acetate microspheres for injection are sprinting to the market
.
In 2020, the terminal sales of triptorelin in public medical institutions in China exceeded 1.
4 billion yuan.
Compared with ordinary injections, microsphere products only require intramuscular injection once a month, which can reduce patient pain and medication burden, and further improve medication tolerance and tolerance.
Accessibility
.

 

　　Due to its good stability, high encapsulation rate, low cost, and few toxic and side effects, liposomal drugs have increased in the international market in recent years.
However, there are currently only 3 liposome-related drugs (5 brands) in China.
Among them, the highest terminal sales in China's public medical institutions in 2020 is CSPC's doxorubicin hydrochloride liposome injection
.
CSPC has a number of products under development in the liposome field.
In terms of 2.
2 new drugs, mitoxantrone hydrochloride liposome injection is sprinted into the market, epirubicin hydrochloride liposome injection and alprostadil lipid for injection The body has been approved for clinical use.
In terms of generic drugs, amphotericin B liposomes for injection are being reported for production, and irinotecan liposome injections have been approved for clinical use
.

 

　　R&D success rate is high, returns are rising rapidly, improved new drugs show advantages in adversity

 

　　With the continuous advancement of medical reform, under the situation of normalization and standardization of national procurement and provincial centralized procurement, the generic drug market is under increasing pressure.
Although innovative drugs have high returns, they have long R&D cycles and large initial investment, which are not suitable for all domestic pharmaceutical companies.
Participate blindly
.
Improved new drugs are improvements to drugs already on the market, emphasizing "superiority".
They have the advantages of relatively high success rate, low risk, long life cycle, and quick return.
It has become the mainstream of global new drug research and development.
Judging from the declaration of domestic pharmaceutical companies, this mainstream trend is also accelerating, and the outbreak period is about to come
.

 

　　Since 2018, among the 2 new chemical drugs that have been declared for marketing, except for category 2.
4 (new indication), category 2.
2 (modulation form improvement) accounts for the largest proportion.
A careful analysis reveals that over 1 billion varieties of modified formulations are the most popular
.
On the one hand, because these large varieties have been on the market for many years, the clinical safety and effectiveness have been recognized, and the market foundation is strong.
The new dosage form will have more advantages in similar products, and it will be easier to quickly obtain the approval of doctors and patients after the market; secondly, In the general atmosphere of centralized procurement, some large-variety generic drug manufacturers have completed one or more rounds of shuffling, freeing up more space for new drugs (including improved new drugs) for cultivation.
Moreover, improved new drugs cannot be cultivated.
Need to "fight at low prices" with generic drugs, and enterprises have greater enthusiasm and freedom
.

 

　　Earlier, most of the domestic improved new drugs were "changes for change.
" Therefore, a batch of products that changed ordinary tablets into capsules, dispersible tablets, and sustained-release tablets were reported for production.
To provide better treatments, changes to granules and oral solutions are gradually increasing, but these technical improvements with low barriers are more likely to be imitated and replaced in the future
.

 

　　In recent years, with the improvement of the R&D capabilities of domestic pharmaceutical companies, some high-barrier technologies, such as liposomes, microspheres, oral membranes, micelles, transdermal patches, etc.
, have become the focus of research and development of improved new drugs.
After a short period of cultivation, the batch of products on the market have shown a trend of skyrocketing year after year in the terminal market.
Some improved new drugs are still under medical protection and quickly occupy a high ground in the market
.

 

　　Nervous system, systemic anti-infection and anti-tumor are currently popular research and development positions for improved formulations
.
The three recommendations are summarized from the approved and under review product information for reference only .
Patients with neurological diseases may accumulate some negative emotions due to the need to take medication for a long time.
If they cannot continue to take the medication according to the amount and need, the condition may be difficult to control.
In addition, the incidence of children with certain diseases is increasing year by year, and stable medication is also increased.
Therefore, it is recommended that improvements in this field can be carried out from the perspectives of long-term effectiveness and ease of use to meet the clinical needs of patients
.
Systemic anti-infective drugs can start from the structural change.
For example, the current antibiotic resistance problem continues to intensify, which has severely weakened the therapeutic effect of the drug.
If only the dosage form is modified, the best effect may not be achieved
.
In terms of anti-tumor drugs, we can start with some new drug delivery systems, such as liposomes, microspheres, micelles, etc.
, with their "assistance", it can improve the stability of patients in vivo and the high sensitivity of drug release in tumors Degree, let the medicine exert the best effect
.

 

　　Source: Mi Nei.
com database, CDE official website, etc.

 

　　Note: The statistics are as of November 2nd, if there are any omissions, please correct me!

　　On October 26, another domestically produced new drug was approved for listing.
Shanghai Yizhong Biotechnology's Paclitaxel polymer micelle for injection is the 12th new chemical drug approved this year
.
In recent years, domestic pharmaceutical companies have gained a lot in the research and development of improved new drugs.
From the perspective of production reports, in 2018, there were 5 chemical drugs in category 2 new drugs (excluding new indications and raw materials) that were declared for marketing.
In 2019, there were 14 There will be 7 in 2020 and 8 from 2021 to the present, and from the perspective of approval, it is also showing a rapid upward trend
.
In the context of medical reform, where is the potential of these new domestic drugs? What are the breakthroughs in future R&D trends?

 

　　14 new and improved drugs have flooded into the 100 billion market, and large varieties and new dosage forms have become popular

 

　　Table 1: Improved new chemical drugs (excluding new indications) approved for marketing since 2018

　　Source: Meinenet MED2.
0 Chinese Drug Evaluation Database

 

　　Since 2018, 14 new modified chemical drugs have been approved for marketing.
From the perspective of treatment, 5 neurologic drugs, 4 systemic anti-infective drugs, 3 anti-tumor and immunomodulators, blood and hematopoietic drugs System medicine and 1 respiratory system medicine each
.
According to data from Menet.
com, the market size of terminal chemical drugs (including biological drugs) in China’s urban public hospitals , county-level public hospitals, urban community centers, and township health centers (Chinese public medical institutions) will reach more than 970 billion yuan in 2020 .
After the new drug goes on the market, it will accelerate the reshuffle of the market structure
.

 

　　From the perspective of registration classification, there are 3 new drugs in category 2.
1 (structure improvement)
.
Levoornidazole is the levorotatory body of ornidazole.
Clinical studies have shown that the efficacy of levornidazole in anti-anaerobic infection is equivalent to ornidazole, the incidence of total adverse reactions is significantly reduced, and clinical application is safer
.
At the terminal of public medical institutions in China, ornidazole reached sales of more than 3 billion yuan in 2019, but the growth rate has been declining in recent years
.
At present, Levo Ornidazole Tablets and Levo Ornidazole Sodium Chloride Injection have been listed on the domestic market.
In 2018, the total sales of Levo Ornidazole Sodium Chloride Injection in China's public medical institutions exceeded 380 million yuan.
Levo Ornidazole Sodium Chloride Injection has entered the market.
In the 2020 National Medical Insurance Catalogue, the growth rate of 2021H1 will rebound, reaching 14%
.

 

　　Ozagrel is a thromboxane synthase inhibitor with anti-platelet aggregation and vasodilator effects
.
At present, related products on the domestic market involve ozagrel sodium and sodium chloride injection, ozagrel sodium glucose injection, ozagrel sodium injection, and ozagrel sodium for injection.
In 2013, the whole product was launched in Chinese public medical institutions.
Sales exceed 1 billion yuan
.
It is reported that the concentrated solution of ozagrel tromethamine for injection has good water solubility, strong long-term stability, and has clinical advantages
.

 

　　Figure 1: Sales of over 1 billion varieties (unit: 100 million yuan)

　　Source: Mi Nei Net Database

 

　　Class 2.
2 new drugs (formulation improvements) involve 10 products, of which new drugs developed around over 1 billion varieties of olanzapine, entecavir, montelukast, paclitaxel, and risperidone are particularly concerned
.

 

　　Oral dissolving membrane is a new drug delivery system, which has the advantages of small size, light weight, convenient taking, no first-pass effect, etc.
It is especially suitable for children , the elderly, and patients with dysphagia
.
Hausen’s olanzapine mouth-melting membrane was approved in 2020 and is the first in China.
Qilu was approved in 2021, and Qilu’s products are currently on sale in the retail market
.
Montelukast is used clinically for the prevention and long-term treatment of asthma in adults and children.
Qilu started the development of oral dissolving membrane in 2013.
Montelukast sodium oral dissolving membrane is the company's second approved listing.
Mouth-melting film, Qilu is currently the first domestically approved enterprise for this product
.

 

　　Entecavir is the first-line treatment for hepatitis B recommended by the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B" in China.
Chronic hepatitis B not only involves adult patients, but it will be more troublesome to deal with if children are sick
.
Entecavir granules from Hunan Warner Pharmaceutical Factory were included in the priority review on the grounds of "children's medicine" and children with hepatitis B have special medicines
.

 

　　Paclitaxel is the largest variety of anti-tumor drug plant alkaloids and other natural medicines.
The approved paclitaxel polymer micelle for injection is an innovative formulation of paclitaxel, which has strong in vivo stability and intratumoral drug The high sensitivity of release, clinical research results show that the objective response rate (ORR) of injection paclitaxel polymer micelles is significantly improved, and the progression-free survival (PFS) is significantly prolonged
.
It is worth noting that the polymer micelle of paclitaxel for injection is the core product of Shanghai Yizhong Pharmaceutical, which has successfully landed on the Sci-tech Innovation Board this year.
The breakthrough has also attracted investors' attention
.

 

　　Risperidone is a major antipsychotic drug.
Luye’s risperidone microspheres for injection (II) is a long-acting injection that is injected intramuscularly every two weeks.
The product can maintain clinically effective blood concentration during use.
The stability of the system improves the convenience of the clinical treatment process
.
Improved drug green groups mentioned, we must think of the company's exclusive products paclitaxel liposome for injection, in 2020, Chinese public medical institutions terminal antineoplastic agents Plant alkaloids and other natural medicines brand TOP20, an injection of paclitaxel fat green leaves Plasmid is at the top of the list.
With such good results, the industry is more confident in the market performance of risperidone microspheres (II) for injection
.

 

　　The cefotaxime sodium tazobactam for injection of Nanjing Youke Pharmaceutical is a new class 2.
3 drug (new compound preparation).
The new drug combines cefotaxime with the β-lactamase inhibitor tazobactam to strongly inhibit The activity of β-lactamase prevents the hydrolysis of cefotaxime, restores the original antibacterial activity and antibacterial spectrum of the antibacterial drug, and solves the unilateral resistance problem of the third-generation cephalosporin
.
In 2019, the sales of terminal cefotaxime in public medical institutions in China were at the level of 2 billion yuan, and the sales of another compound preparation, cefotaxime and sulbactam, exceeded 1 billion yuan.
The market potential of this new drug is promising
.

 

　　20 new drugs are ready to be launched, Qilu aggressively attacked mouth-melting membranes, Shiyao used liposomes, and Livzon microspheres attracted attention

 

　　Table 2: Status of improved new drugs that have been declared for marketing and under review since 2018 (excluding new indications)

　　Source: Meinenet MED2.
0 Chinese Drug Evaluation Database

 

　　Since 2018, there are 20 new class 2 chemical drugs that have been declared for marketing and are under review (according to product + company statistics), two of which are new compound preparations (class 2.
3 new drugs), of which Adapalene Clindamycin Hydrochloride Compound Gel For the treatment of acne vulgaris, it is more effective than single prescription
.
Among the other improved new drugs under review, the marketing application of Levoornidazole Dispersible Tablets and Levoornidazole Capsules of Warner Pharmaceuticals has now entered the "under review" status, which is expected to further expand the domestic Levoornidazole product line camp.

.

 

　　Qilu continues to aggressively attack the field of oral dissolving membranes.
In addition to the marketed olanzapine oral dissolving membranes and montelukast sodium oral dissolving membranes (the first in China), the tadalafil oral dissolving membranes and aripiprazole oral dissolving membranes are currently under review.
Memantine hydrochloride membrane and memantine hydrochloride mouth-melting membrane are expected to be the first in China
.
In 2020, at the terminal of public medical institutions in China, aripiprazole is a species exceeding 1 billion, and the sales of tadalafil and memantine exceed 100 million yuan and 600 million yuan respectively
.

 

　　Hengrui and Livzon are also developing new formulations for large varieties
.
Before the collection of dexmedetomidine, Hengrui had always been a leader in this product and had a certain brand foundation
.
With the price reduction of dexmedetomidine, the market demand has further expanded.
In 2020, the sales of this product in public medical institutions in China will be close to 4 billion yuan.
At present, the main dosage form is injection, while nasal spray has convenient use and low dose.
, Avoid liver first-pass effect, the absorption rate can be compared with intravenous administration and other advantages, can also be used for local and systemic drugs, the potential after the market is worth looking forward to
.

 

　　Livzon has been deeply involved in the field of microspheres for many years, and currently has over 1 billion products of leuprorelin acetate microspheres for injection, and triptorelin acetate microspheres for injection are sprinting to the market
.
In 2020, the terminal sales of triptorelin in public medical institutions in China exceeded 1.
4 billion yuan.
Compared with ordinary injections, microsphere products only require intramuscular injection once a month, which can reduce patient pain and medication burden, and further improve medication tolerance and tolerance.
Accessibility
.

 

　　Due to its good stability, high encapsulation rate, low cost, and few toxic and side effects, liposomal drugs have increased in the international market in recent years.
However, there are currently only 3 liposome-related drugs (5 brands) in China.
Among them, the highest terminal sales in China's public medical institutions in 2020 is CSPC's doxorubicin hydrochloride liposome injection
.
CSPC has a number of products under development in the liposome field.
In terms of 2.
2 new drugs, mitoxantrone hydrochloride liposome injection is sprinted into the market, epirubicin hydrochloride liposome injection and alprostadil lipid for injection The body has been approved for clinical use.
In terms of generic drugs, amphotericin B liposomes for injection are being reported for production, and irinotecan liposome injections have been approved for clinical use
.

 

　　R&D success rate is high, returns are rising rapidly, improved new drugs show advantages in adversity

 

　　With the continuous advancement of medical reform, under the situation of normalization and standardization of national procurement and provincial centralized procurement, the generic drug market is under increasing pressure.
Although innovative drugs have high returns, they have long R&D cycles and large initial investment, which are not suitable for all domestic pharmaceutical companies.
Participate blindly
.
Improved new drugs are improvements to drugs already on the market, emphasizing "superiority".
They have the advantages of relatively high success rate, low risk, long life cycle, and quick return.
It has become the mainstream of global new drug research and development.
Judging from the declaration of domestic pharmaceutical companies, this mainstream trend is also accelerating, and the outbreak period is about to come
.

 

　　Since 2018, among the 2 new chemical drugs that have been declared for marketing, except for category 2.
4 (new indication), category 2.
2 (modulation form improvement) accounts for the largest proportion.
A careful analysis reveals that over 1 billion varieties of modified formulations are the most popular
.
On the one hand, because these large varieties have been on the market for many years, the clinical safety and effectiveness have been recognized, and the market foundation is strong.
The new dosage form will have more advantages in similar products, and it will be easier to quickly obtain the approval of doctors and patients after the market; secondly, In the general atmosphere of centralized procurement, some large-variety generic drug manufacturers have completed one or more rounds of shuffling, freeing up more space for new drugs (including improved new drugs) for cultivation.
Moreover, improved new drugs cannot be cultivated.
Need to "fight at low prices" with generic drugs, and enterprises have greater enthusiasm and freedom
.

 

　　Earlier, most of the domestic improved new drugs were "changes for change.
" Therefore, a batch of products that changed ordinary tablets into capsules, dispersible tablets, and sustained-release tablets were reported for production.
To provide better treatments, changes to granules and oral solutions are gradually increasing, but these technical improvements with low barriers are more likely to be imitated and replaced in the future
.

 

　　In recent years, with the improvement of the R&D capabilities of domestic pharmaceutical companies, some high-barrier technologies, such as liposomes, microspheres, oral membranes, micelles, transdermal patches, etc.
, have become the focus of research and development of improved new drugs.
After a short period of cultivation, the batch of products on the market have shown a trend of skyrocketing year after year in the terminal market.
Some improved new drugs are still under medical protection and quickly occupy a high ground in the market
.

 

　　Nervous system, systemic anti-infection and anti-tumor are currently popular research and development positions for improved formulations
.
The three recommendations are summarized from the approved and under review product information for reference only .
Patients with neurological diseases may accumulate some negative emotions due to the need to take medication for a long time.
If they cannot continue to take the medication according to the amount and need, the condition may be difficult to control.
In addition, the incidence of children with certain diseases is increasing year by year, and stable medication is also increased.
Therefore, it is recommended that improvements in this field can be carried out from the perspectives of long-term effectiveness and ease of use to meet the clinical needs of patients
.
Systemic anti-infective drugs can start from the structural change.
For example, the current antibiotic resistance problem continues to intensify, which has severely weakened the therapeutic effect of the drug.
If only the dosage form is modified, the best effect may not be achieved
.
In terms of anti-tumor drugs, we can start with some new drug delivery systems, such as liposomes, microspheres, micelles, etc.
, with their "assistance", it can improve the stability of patients in vivo and the high sensitivity of drug release in tumors Degree, let the medicine exert the best effect
.

 

　　Source: Mi Nei.
com database, CDE official website, etc.

 

　　Note: The statistics are as of November 2nd, if there are any omissions, please correct me!