80 new drugs explode the 400 billion Chinese patent medicine market!

Medical Network News on March 4, before the Spring Festival, "Several Policy Measures on Accelerating the Development of Traditional Chinese Medicine Characteristics" was released to the public, aiming to promote the coordinated development of Chinese and Western medicine, which triggered a positive response in the industry: it mentioned that the development vitality of the Chinese medicine industry should be improved and optimized The review and approval management of traditional Chinese medicines and the improvement of classification and registration management of traditional Chinese medicines have provided a "strengthening shot" for Chinese medicine companies.
According to data from Meinenet, 2015 was a blowout period for the listing of new Chinese patent medicines, and there was a sharp decline in the following years.
In 2020, only three were approved (according to the approval document).
With the new policy, can my country's Chinese medicine industry become active? The curtain has just kicked off in 2021.
Two companies have already applied for the listing of new Chinese patent medicines.
What new drugs are expected to be approved this year?

 

80 new Chinese patent medicines are on the market: the number of gynecology is the largest, and the pediatrics has a big surprise

 

According to data from Mi Nei.
com, in 2019, the total market size of Chinese patent medicines in China's urban public hospitals , county-level public hospitals, urban community centers, and township health centers (Chinese public medical institutions) terminals and China's urban entity pharmacies terminals has approached 400 billion yuan.
In the first half of 2020, affected by the epidemic, the sales of proprietary Chinese medicines in public medical institutions in China fell by 18%, and the annual sales of proprietary Chinese medicines in physical pharmacies in Chinese cities are also expected to remain at around 100 billion yuan.
In recent years, the growth rate of the Chinese patent medicine market has slowed down, and there is an urgent need for new power to ignite new passions.

 

Table 1: New Chinese patent medicines approved for marketing from 2015 to 2020 (statistics based on approval documents)

Source: Minet.
com MID, MED2.
0 database

 

　　From 2015 to 2020, there are about 80 Chinese patent medicines that have been declared as new drugs and have been marketed (according to the approval document), showing a cliff-like trend in number: the number of approvals exceeded 70 in 2015, and then fell to every year from 2016 to 2019 Only 1-2, and 3 were approved in 2020 just past.
Recall that in 2015, it was called the "Medicine Administration Year" by the industry.
Among them, the reform of drug review was the most prominent.
The self-examination and verification of drug clinical trial data that shocked the industry was launched that year.
At the same time, the threshold for new drug approval was raised through the reform of the review and approval process.
, Reducing the approval of new drugs of low quality, ineffective improvement, oversupply, etc.
.
.
.
These reforms are conducive to the healthy development of domestic drug research and development in the long run.
After that, each drug company has adjusted the application method for new drugs that are applied for the market.
The quality of the materials is higher, and the new drugs approved since then can be said to be "expensive and less expensive.
"

 

　　In terms of major categories, the most approved new drugs for gynecological drugs involve four subcategories of women’s menopausal drugs, mammary gland hyperplasia drugs, gynecological inflammation drugs, and gynecological menstrual regulation drugs.
This benefited from the direct implementation of the country’s administration of women’s and children’s drugs in the past few years.
Online procurement policy.
Fangsheng Pharmaceutical has the largest number of approvals, involving two products, and the remaining 30 pharmaceutical companies have all been approved for one new drug.

 

　　Thanks to policy inclination, pediatric drugs have enjoyed the best growth momentum in recent years.
At the terminals of public medical institutions in China, the overall sales growth rate of this category from 2015 to 2019 exceeded 10% annually, and the physical pharmacies in Chinese cities also maintained a positive annual growth rate.
The situation.
In 2019, two new pediatric drugs were approved and heatedly discussed in the industry.
Fangsheng Pharmaceutical’s Xiaoer Jingxing Cough Granules are suitable for the treatment of mild bronchitis caused by cold and heat in children.
Tasly’s Shao Ma Zhijing Granules can treat tics.
Symptoms (Tourette syndrome) and TCM syndrome differentiation of chronic tic disorder belong to patients with hyperhepatic wind movement and internal disturbance of phlegm and fire.

 

　　In the past 2020, the three tens of billions of markets for digestive system diseases, musculoskeletal system diseases, and respiratory diseases ushered in blockbuster new drugs: Beijing Wuhe Boao Pharmaceutical’s Mulberry total alkaloid tablets were hailed as the first in the past 10 years.
An approved new Chinese patent medicine for diabetes, Jiangsu Kangyuan Pharmaceutical's Jingu Pain Gel administration route has unique advantages.
Lianhua Qingke Tablets is another new product of Ling Pharmaceutical following the "Lianhua Qingwen" series.

 

　　Exclusive new drugs are favored by medical insurance, and sales of these products skyrocket year after year

 

　　Table 2: Medical insurance status of exclusive new drugs approved for marketing in 2015-2020

　　Source: Minet.
com China Medical Insurance Catalog Encyclopedia Database

 

　　Of the 80 new Chinese patent medicines approved for marketing in 2015-2020, 20 are exclusive, and most of these exclusive varieties have been included in the national medical insurance.
One of the hottest events in the pharmaceutical industry in 2020 is the medical insurance negotiations.
Tribulus Terrestris Saponins Capsules, Wuwei Kushen Enteric-coated Capsules, Shao Ma Zhijing Granules, Pediatric Jingxing Cough Granules, Muscle and Bone Pain Relief Gel, Lianhua Qingcough Tablets, Mulberry Branch Total alkaloid tablets successfully joined the ranks of medical insurance.
The new version of the medical insurance catalog will be implemented on March 1 this year, and the sales of the exclusive varieties of these new catalogs in the terminal of public medical institutions in China are expected to increase rapidly.

 

　　Table 3: The growth rate of some of the best-selling exclusive varieties in the terminal of public medical institutions in China

　　Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

 

　　Figure 1: Channel layout of Danlu Capsule

　　Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

 

　　Suzhong Pharmaceutical's Danlu Capsule was approved for marketing in 2015.
It is reported that this exclusive product has a unique mechanism of action, does not affect normal estrogen secretion, has a fast onset, effectively reduces the mass of breast hyperplasia, and is particularly effective for breast pain.
The product entered the national medical insurance catalog in 2017, and then began to rapidly increase its volume in public medical institutions in China.
In 2019, sales exceeded 20 million yuan.
In the first half of 2020, the overall environment was affected by the epidemic, and the product still maintained a growth of more than 20%.
From the perspective of channels, urban public hospitals and county-level public hospitals are the main battlefields of this product, and the proportion of urban public hospitals in the first half of 2020 has risen to 60%.

 

　　Figure 2: Channel layout of Guanxinning tablets

　　Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

 

　　According to data, the Guanxinning tablets of CP Qingchunbao Pharmaceutical under Shanghai Pharmaceutical Group were established in 2002, approved for listing in 2015, and entered the national medical insurance catalog in 2017.
They have overcome all obstacles and become a dazzling star in cardiovascular disease drugs.
In 2019, the sales of the new drug exceeded 30 million yuan, and the growth rate in the first half of 2020 also exceeded 100%.
From the perspective of channels, urban public hospitals and county-level public hospitals are the main battlefields for this exclusive product, but it cannot be ignored that the proportion of urban community centers and township health centers is also increasing year by year.

 

　　Figure 3: Channel structure of Shouhui laxative capsules

　　Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

 

　　Lunan Houpu Pharmaceutical's Shouhui Laxative Capsule is also a major product that the company has made for ten years.
It is aimed at treating functional constipation with deficiency of both Qi and Yin.
The product was approved for listing in 2015.
Without the "blessing" of medical insurance, the terminal sales growth rate in China's public medical institutions in 2019 was as high as 756.
90%, and the growth rate in the first half of 2020 also exceeded 100%.
From the perspective of channels, the proportion of county-level public hospitals has increased year by year, and urban community centers and township health centers have also begun to increase their distribution.
According to the official website of Lunan Pharmaceutical, the company has always insisted on conducting academic research on Shouhui Laxative Capsules, and has developed Shouhui Mate (probiotics) to achieve the best effect of the product through combination medication.

 

　　Figure 4: Channel pattern of Jinhua Qinggan Granules

　　Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

 

　　Jinhua Qinggan Granules is the result of a major scientific and technological research project carried out by the Beijing Municipal People’s Government during the prevention and treatment of H1N1 influenza in 2009.
It is suitable for influenza.
It is recommended to be included in the list of "three drugs and three prescriptions" during the epidemic prevention and control period in 2020.
in.
The new drug was approved for listing in 2016.
In 2019, the terminal sales of public medical institutions in China have exceeded 180 million yuan, and the growth rate in the first half of 2020 will be around 16%.
From the perspective of channels, urban public hospitals accounted for the largest proportion, and the proportion of urban community centers also rose to over 34% in the first half of 2020.

 

　　Seven Class 1 new drugs are coming, Tasly, Kangyuan, Fangsheng.
.
.

 

　　According to CDE data, within the first two months of 2021, Tasly and Hubei Youersheng Pharmaceuticals successively applied for the listing of two new class 1 Chinese patent medicines, plus 5 new class 1 drugs declared for marketing in 2020, and 7 new drugs will be listed on the market.
The road to the market of pound Chinese patent medicine has attracted much attention.

 

　　Table 4: Status of new proprietary Chinese medicines declared and under review since 2018

　　Source: China Drug Clinical Trial Publicity Library of Meinenet

 

　　Kun Yining Granules was originally a new Chinese medicine independently developed by Zhejiang Institute of Chinese Materia Medica for the treatment of female menopausal syndrome.
In 2015, the institute signed a technology transfer contract with Tasly, with a total contract price of 30 million yuan.
Tasly has successfully won the new drug approval for pediatric medicine Shao Ma Zhijing Granules in 2019.
Can it make another success in the field of gynecological medicine?

 

　　It is reported that the prescription of Jingule tablets is a clinically effective prescription collected by Fangsheng Pharmaceutical.
The prescription is aimed at the cause of osteoarthritis local pain and unfavorable activities.
It has the effects of promoting blood circulation and relaxing muscles, relieving pain, and strengthening the kidney and bones.
It is suitable for osteoarthritis with stasis of tendons and veins, symptoms such as joint pain, swelling, poor activity, numbness of the limbs, sore waist and knees.
In 2015, the company's approved new Chinese patent medicines include Jingangteng Dispersible Tablets and Jingangteng Chewable Tablets.
In 2019, it was approved for Xiaoer Jingxing Cough Granules.
Fangsheng Pharmaceutical's strength in the research and development of new Chinese patent medicines cannot be underestimated.

 

　　When it comes to Kangyuan Pharmaceutical’s leading product for respiratory diseases, Reduning Injection deserves its name.
This product is a new Chinese patent medicine approved for marketing by the company in 2005 and has grown into the company’s largest variety.
It also helped the company establish its market position in the field of drugs for respiratory diseases.
Can Yinqiao Qingre Tablets, which are also used for respiratory diseases, become a new driving force for the company's performance? We will wait and see.

 

　　Conclusion

 

　　On February 23, the "Regulations for the Publication of Technical Evaluation Reports of the Center for Drug Evaluation (Trial)" was released to the public, announcing that starting from June 1, 2021, the technical evaluation reports of pharmaceuticals will be gradually published .
The industry believes that the new regulations will make the application of new drugs Be more transparent.
After the introduction of the new regulations, pharmaceutical companies will undoubtedly treat application materials cautiously, so that peers and the public can refer to and supervise them.
In recent years, new policies have been introduced at the national level to regulate all aspects of the drug market.
This will also help Chinese patent medicine companies to avoid detours in the development, application, and listing of new drugs, and make more high-quality new drugs become market explosions.

 

　　Source: Mynet database, company announcements, official website, etc.

 

　　Note: The statistics are as of February 26, if there are any omissions, please correct me!

　　Medical Network News on March 4, before the Spring Festival, "Several Policy Measures on Accelerating the Development of Traditional Chinese Medicine Characteristics" was released to the public, aiming to promote the coordinated development of Chinese and Western medicine, which triggered a positive response in the industry: it mentioned that the development vitality of the Chinese medicine industry should be improved and optimized The review and approval management of traditional Chinese medicines and the improvement of classification and registration management of traditional Chinese medicines have provided a "strengthening shot" for Chinese medicine companies.
According to data from Meinenet, 2015 was a blowout period for the listing of new Chinese patent medicines, and there was a sharp decline in the following years.
In 2020, only three were approved (according to the approval document).
With the new policy, can my country's Chinese medicine industry become active? The curtain has just kicked off in 2021.
Two companies have already applied for the listing of new Chinese patent medicines.
What new drugs are expected to be approved this year?

 

　　80 new Chinese patent medicines are on the market: the number of gynecology is the largest, and the pediatrics has a big surprise

 

　　According to data from Mi Nei.
com, in 2019, the total market size of Chinese patent medicines in China's urban public hospitals , county-level public hospitals, urban community centers, and township health centers (Chinese public medical institutions) terminals and China's urban entity pharmacies terminals has approached 400 billion yuan.
In the first half of 2020, affected by the epidemic, the sales of proprietary Chinese medicines in public medical institutions in China fell by 18%, and the annual sales of proprietary Chinese medicines in physical pharmacies in Chinese cities are also expected to remain at around 100 billion yuan.
In recent years, the growth rate of the Chinese patent medicine market has slowed down, and there is an urgent need for new power to ignite new passions.

 

　　Table 1: New Chinese patent medicines approved for marketing from 2015 to 2020 (statistics based on approval documents)

　　Source: Minet.
com MID, MED2.
0 database

 

　　From 2015 to 2020, there are about 80 Chinese patent medicines that have been declared as new drugs and have been marketed (according to the approval document), showing a cliff-like trend in number: the number of approvals exceeded 70 in 2015, and then fell to every year from 2016 to 2019 Only 1-2, and 3 were approved in 2020 just past.
Recall that in 2015, it was called the "Medicine Administration Year" by the industry.
Among them, the reform of drug review was the most prominent.
The self-examination and verification of drug clinical trial data that shocked the industry was launched that year.
At the same time, the threshold for new drug approval was raised through the reform of the review and approval process.
, Reducing the approval of new drugs of low quality, ineffective improvement, oversupply, etc.
.
.
.
These reforms are conducive to the healthy development of domestic drug research and development in the long run.
After that, each drug company has adjusted the application method for new drugs that are applied for the market.
The quality of the materials is higher, and the new drugs approved since then can be said to be "expensive and less expensive.
"

 

　　In terms of major categories, the most approved new drugs for gynecological drugs involve four subcategories of women’s menopausal drugs, mammary gland hyperplasia drugs, gynecological inflammation drugs, and gynecological menstrual regulation drugs.
This benefited from the direct implementation of the country’s administration of women’s and children’s drugs in the past few years.
Online procurement policy.
Fangsheng Pharmaceutical has the largest number of approvals, involving two products, and the remaining 30 pharmaceutical companies have all been approved for one new drug.

 

　　Thanks to policy inclination, pediatric drugs have enjoyed the best growth momentum in recent years.
At the terminals of public medical institutions in China, the overall sales growth rate of this category from 2015 to 2019 exceeded 10% annually, and the physical pharmacies in Chinese cities also maintained a positive annual growth rate.
The situation.
In 2019, two new pediatric drugs were approved and heatedly discussed in the industry.
Fangsheng Pharmaceutical’s Xiaoer Jingxing Cough Granules are suitable for the treatment of mild bronchitis caused by cold and heat in children.
Tasly’s Shao Ma Zhijing Granules can treat tics.
Symptoms (Tourette syndrome) and TCM syndrome differentiation of chronic tic disorder belong to patients with hyperhepatic wind movement and internal disturbance of phlegm and fire.

 

　　In the past 2020, the three tens of billions of markets for digestive system diseases, musculoskeletal system diseases, and respiratory diseases ushered in blockbuster new drugs: Beijing Wuhe Boao Pharmaceutical’s Mulberry total alkaloid tablets were hailed as the first in the past 10 years.
An approved new Chinese patent medicine for diabetes, Jiangsu Kangyuan Pharmaceutical's Jingu Pain Gel administration route has unique advantages.
Lianhua Qingke Tablets is another new product of Ling Pharmaceutical following the "Lianhua Qingwen" series.

 

　　Exclusive new drugs are favored by medical insurance, and sales of these products skyrocket year after year

 

　　Table 2: Medical insurance status of exclusive new drugs approved for marketing in 2015-2020

　　Source: Minet.
com China Medical Insurance Catalog Encyclopedia Database

 

　　Of the 80 new Chinese patent medicines approved for marketing in 2015-2020, 20 are exclusive, and most of these exclusive varieties have been included in the national medical insurance.
One of the hottest events in the pharmaceutical industry in 2020 is the medical insurance negotiations.
Tribulus Terrestris Saponins Capsules, Wuwei Kushen Enteric-coated Capsules, Shao Ma Zhijing Granules, Pediatric Jingxing Cough Granules, Muscle and Bone Pain Relief Gel, Lianhua Qingcough Tablets, Mulberry Branch Total alkaloid tablets successfully joined the ranks of medical insurance.
The new version of the medical insurance catalog will be implemented on March 1 this year, and the sales of the exclusive varieties of these new catalogs in the terminal of public medical institutions in China are expected to increase rapidly.

 

　　Table 3: The growth rate of some of the best-selling exclusive varieties in the terminal of public medical institutions in China

　　Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

 

　　Figure 1: Channel layout of Danlu Capsule

　　Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

 

　　Suzhong Pharmaceutical's Danlu Capsule was approved for marketing in 2015.
It is reported that this exclusive product has a unique mechanism of action, does not affect normal estrogen secretion, has a fast onset, effectively reduces the mass of breast hyperplasia, and is particularly effective for breast pain.
The product entered the national medical insurance catalog in 2017, and then began to rapidly increase its volume in public medical institutions in China.
In 2019, sales exceeded 20 million yuan.
In the first half of 2020, the overall environment was affected by the epidemic, and the product still maintained a growth of more than 20%.
From the perspective of channels, urban public hospitals and county-level public hospitals are the main battlefields of this product, and the proportion of urban public hospitals in the first half of 2020 has risen to 60%.

 

　　Figure 2: Channel layout of Guanxinning tablets

　　Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

 

　　According to data, the Guanxinning tablets of CP Qingchunbao Pharmaceutical under Shanghai Pharmaceutical Group were established in 2002, approved for listing in 2015, and entered the national medical insurance catalog in 2017.
They have overcome all obstacles and become a dazzling star in cardiovascular disease drugs.
In 2019, the sales of the new drug exceeded 30 million yuan, and the growth rate in the first half of 2020 also exceeded 100%.
From the perspective of channels, urban public hospitals and county-level public hospitals are the main battlefields for this exclusive product, but it cannot be ignored that the proportion of urban community centers and township health centers is also increasing year by year.

 

　　Figure 3: Channel structure of Shouhui laxative capsules

　　Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

 

　　Lunan Houpu Pharmaceutical's Shouhui Laxative Capsule is also a major product that the company has made for ten years.
It is aimed at treating functional constipation with deficiency of both Qi and Yin.
The product was approved for listing in 2015.
Without the "blessing" of medical insurance, the terminal sales growth rate in China's public medical institutions in 2019 was as high as 756.
90%, and the growth rate in the first half of 2020 also exceeded 100%.
From the perspective of channels, the proportion of county-level public hospitals has increased year by year, and urban community centers and township health centers have also begun to increase their distribution.
According to the official website of Lunan Pharmaceutical, the company has always insisted on conducting academic research on Shouhui Laxative Capsules, and has developed Shouhui Mate (probiotics) to achieve the best effect of the product through combination medication.

 

　　Figure 4: Channel pattern of Jinhua Qinggan Granules

　　Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

 

　　Jinhua Qinggan Granules is the result of a major scientific and technological research project carried out by the Beijing Municipal People’s Government during the prevention and treatment of H1N1 influenza in 2009.
It is suitable for influenza.
It is recommended to be included in the list of "three drugs and three prescriptions" during the epidemic prevention and control period in 2020.
in.
The new drug was approved for listing in 2016.
In 2019, the terminal sales of public medical institutions in China have exceeded 180 million yuan, and the growth rate in the first half of 2020 will be around 16%.
From the perspective of channels, urban public hospitals accounted for the largest proportion, and the proportion of urban community centers also rose to over 34% in the first half of 2020.

 

　　Seven Class 1 new drugs are coming, Tasly, Kangyuan, Fangsheng.
.
.

 

　　According to CDE data, within the first two months of 2021, Tasly and Hubei Youersheng Pharmaceuticals successively applied for the listing of two new class 1 Chinese patent medicines, plus 5 new class 1 drugs declared for marketing in 2020, and 7 new drugs will be listed on the market.
The road to the market of pound Chinese patent medicine has attracted much attention.

 

　　Table 4: Status of new proprietary Chinese medicines declared and under review since 2018

　　Source: China Drug Clinical Trial Publicity Library of Meinenet

 

　　Kun Yining Granules was originally a new Chinese medicine independently developed by Zhejiang Institute of Chinese Materia Medica for the treatment of female menopausal syndrome.
In 2015, the institute signed a technology transfer contract with Tasly, with a total contract price of 30 million yuan.
Tasly has successfully won the new drug approval for pediatric medicine Shao Ma Zhijing Granules in 2019.
Can it make another success in the field of gynecological medicine?

 

　　It is reported that the prescription of Jingule tablets is a clinically effective prescription collected by Fangsheng Pharmaceutical.
The prescription is aimed at the cause of osteoarthritis local pain and unfavorable activities.
It has the effects of promoting blood circulation and relaxing muscles, relieving pain, and strengthening the kidney and bones.
It is suitable for osteoarthritis with stasis of tendons and veins, symptoms such as joint pain, swelling, poor activity, numbness of the limbs, sore waist and knees.
In 2015, the company's approved new Chinese patent medicines include Jingangteng Dispersible Tablets and Jingangteng Chewable Tablets.
In 2019, it was approved for Xiaoer Jingxing Cough Granules.
Fangsheng Pharmaceutical's strength in the research and development of new Chinese patent medicines cannot be underestimated.

 

　　When it comes to Kangyuan Pharmaceutical’s leading product for respiratory diseases, Reduning Injection deserves its name.
This product is a new Chinese patent medicine approved for marketing by the company in 2005 and has grown into the company’s largest variety.
It also helped the company establish its market position in the field of drugs for respiratory diseases.
Can Yinqiao Qingre Tablets, which are also used for respiratory diseases, become a new driving force for the company's performance? We will wait and see.

 

　　Conclusion

 

　　On February 23, the "Regulations for the Publication of Technical Evaluation Reports of the Center for Drug Evaluation (Trial)" was released to the public, announcing that starting from June 1, 2021, the technical evaluation reports of pharmaceuticals will be gradually published .
The industry believes that the new regulations will make the application of new drugs Be more transparent.
After the introduction of the new regulations, pharmaceutical companies will undoubtedly treat application materials cautiously, so that peers and the public can refer to and supervise them.
In recent years, new policies have been introduced at the national level to regulate all aspects of the drug market.
This will also help Chinese patent medicine companies to avoid detours in the development, application, and listing of new drugs, and make more high-quality new drugs become market explosions.

 

　　Source: Mynet database, company announcements, official website, etc.

 

　　Note: The statistics are as of February 26, if there are any omissions, please correct me!