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Recently, a number of policies such as the "14th Five-Year Plan for National Drug Safety and Promotion of High-Quality Development" and "The 14th Five-Year Plan for the Development of Traditional Chinese Medicine" have been successively introduced, increasing the support for the traditional Chinese medicine industry from the top-level design.
Support efforts to encourage innovation in the traditional Chinese medicine industry
.
Under the policy dividend and drug demand, Chinese medicine companies have also accelerated the pace of product innovation to break the market's stereotype of "focusing on sales and ignoring research and development" of traditional Chinese medicine companies
.
With the successive disclosure of the 2021 annual reports of Chinese medicine listed companies, the financial statements of each company in 2021 are visually presented to investors
.
As of April 13, the data of 24 TCM listed companies that have disclosed their annual reports show that a large number of TCM listed companies continue to increase their investment in research and development, and begin to actively think about and find the goals and methods of TCM innovation
.
Increased investment, R&D innovation is proportional to output A reporter from the Pharmaceutical Economics News found that in the past three years, many listed traditional Chinese medicine companies have gradually increased the proportion of R&D investment in revenue, and the investment amount has increased significantly compared with the past
.
According to the annual report data, from 2019 to 2021, among the listed Chinese medicine companies with R&D investment of more than 100 million yuan, Kangyuan Pharmaceutical, Yiling Pharmaceutical, Tasly, China Resources Sanjiu and other companies have the highest R&D investment and proportion
.
Among them, Kangyuan Pharmaceutical has invested 465 million yuan, 395 million yuan and 501 million yuan in research and development in the past three years, and research and development investment accounted for more than 10% of its revenue
.
Table 1: Some listed Chinese medicine companies with R&D investment of over 100 million yuan (data source: annual report) CDE data shows that in 2021, CDE accepted a total of about 1,360 Chinese medicine applications, including 60 new drug applications, an increase of 32 applications compared with 2020.
An increase of 114.
29%
.
According to the official website of the State Food and Drug Administration, a total of 17 new Chinese medicines have been approved for marketing from 2019 to 2021
.
Among them, 12 new Chinese medicine drugs will be approved in 2021, the highest number of approvals in recent years
.
Specific to related companies, from 2019 to 2021, Yiling Pharmaceutical has a total of 3 new Chinese medicines approved for listing, and Tasly and Kangyuan Pharmaceutical have respectively 2 approved, ranking among the top companies in the number of approved drugs
.
It can be seen that the amount of R&D investment not only represents the core competitiveness of an enterprise, but also is proportional to technological innovation and output
.
Despite the high investment, the listing of new Chinese medicines has also brought considerable commercial profits to the company
.
Take Yiling Pharmaceutical's Lianhua Qingke Tablets as an example.
In May 2020, the drug obtained the approval for drug registration, and passed the medical insurance negotiation at the end of the year, and was included in the 2020 version of the National Medical Insurance Catalog for the first time
.
According to data from Minet.
com, in the first half of 2021, the sales of Lianhua Qingke Tablets in public medical institutions in China reached 2.
11 million yuan, and commercial returns are gradually emerging
.
Convergence of the track, "overtaking on the curve" in the field of differentiated treatment In the context of the gradual increase in the innovation strength of Chinese medicine companies, it is more important to correctly choose the "track" for new drug research and development
.
From the perspective of drug classification, the new traditional Chinese medicines that have been launched in the past five years mainly focus on the advantages and characteristics of traditional Chinese medicine treatment fields such as cardiovascular and cerebrovascular, respiratory, digestive, endocrine, women and children, and the research and development of new traditional Chinese medicines is relatively concentrated
.
At the same time, a reporter from the "Medical Economic News" found that most Chinese medicine companies tend to be homogenized in the field of drug research and development, and the innovation attribute is not obvious
.
For example, from the perspective of drug use, among the 60 new drug applications of traditional Chinese medicine accepted by CDE in 2021, digestive system, respiratory system, and cardiovascular and cerebrovascular diseases are still the top three drug fields of new drug applications for traditional Chinese medicine
.
According to Deng Yong, a researcher at the National Institute of Traditional Chinese Medicine Development and Strategy, Beijing University of Traditional Chinese Medicine, the core competitiveness of new traditional Chinese medicine research and development needs to be further improved, including the patented technical value and commercial value of prescriptions
.
In response to the situation of multiple varieties of new drugs under research in traditional Chinese medicine with the same disease, some companies have begun to adjust the track and pay more attention to differentiated innovation
.
In the 2021 annual report, Kangyuan Pharmaceutical mentioned that in terms of new drugs under research in traditional Chinese medicine, in 2022, it will accelerate the establishment and research and development of drugs for pediatrics, cardiovascular, geriatrics and metabolic diseases, expand new clinical fields, and adjust clinical promotion strategies.
The output of new drugs forms a continuous output capability
.
And strengthen the research on the cultivation of key medical insurance or basic drugs that have been listed in traditional Chinese medicine.
Among them, the research and development investment of Jinzhen Oral Liquid Project, Maxing Zhixiao Granules Project, and Zixin Biqiu Granules project amounted to 12.
0716 million yuan, 10.
2309 million yuan and 6.
3973 million yuan respectively.
10,000 yuan, and the total R&D investment accounted for 0.
79% of the operating income
.
In addition, traditional Chinese medicine companies such as Buchang Pharmaceutical, Yiling Pharmaceutical, and Kangyuan Pharmaceutical have also opened up business lines such as innovative chemical drugs, biological drugs, and vaccines
.
As of the first half of 2021, Yiling Pharmaceutical has 4 first-class innovative drug varieties entering the clinical stage, and several first-class innovative drugs are in the preclinical research stage
.
Among them, Aniprofen Injection, a non-steroidal analgesic and anti-inflammatory drug used for postoperative pain patients, has entered Phase III clinical trials
.
In 2021, CR Sanjiu will have 71 research projects, mainly focusing on oncology, orthopedics, skin, respiratory, anti-infection and other fields, combining imitation and innovation to carry out product layout
.
Table 2: Research and development of new chemical drugs in Yiling Pharmaceutical (Data source: corporate annual report) Internal and external training, diversified layout, breaking through the "gene background" limitation of traditional Chinese medicine However, for most enterprises, even if the awareness of new traditional Chinese medicine research and development innovation Once awakened, we must keep abreast of changes in policy and industry environment, so that we can "take advantage of the wind and leverage"
.
However, it is not easy to adjust the strategic layout in time
.
A research and development staff of a domestic listed Chinese medicine company said frankly, "The 'gene background' of Chinese medicine is too strong, and it is very limited to do biological drug research and development in-house
.
If Chinese medicine companies want to break the bottleneck of performance growth and maintain a long-term stable development trend, it is urgently needed.
Enhance innovation awareness and make products more diversified
.
" With the advancement of a series of domestic medical reform policies, the pharmaceutical industry has accelerated its transformation and upgrading, and traditional Chinese medicine companies have transformed into innovative drugs and high-end generic drugs, which is also a major challenge to their research and development capabilities.
.
Some people in the industry also pointed out that from the perspective of the successful transformation of Chinese medicine companies in China, the company's persistence in R&D and innovation is inseparable
.
In recent years, some powerful traditional Chinese medicine companies have actively carried out international cooperation and development while accelerating the progress of innovation and research and development, and constantly deployed domestic and overseas markets, thereby enhancing their competitiveness and influence
.
Support efforts to encourage innovation in the traditional Chinese medicine industry
.
Under the policy dividend and drug demand, Chinese medicine companies have also accelerated the pace of product innovation to break the market's stereotype of "focusing on sales and ignoring research and development" of traditional Chinese medicine companies
.
With the successive disclosure of the 2021 annual reports of Chinese medicine listed companies, the financial statements of each company in 2021 are visually presented to investors
.
As of April 13, the data of 24 TCM listed companies that have disclosed their annual reports show that a large number of TCM listed companies continue to increase their investment in research and development, and begin to actively think about and find the goals and methods of TCM innovation
.
Increased investment, R&D innovation is proportional to output A reporter from the Pharmaceutical Economics News found that in the past three years, many listed traditional Chinese medicine companies have gradually increased the proportion of R&D investment in revenue, and the investment amount has increased significantly compared with the past
.
According to the annual report data, from 2019 to 2021, among the listed Chinese medicine companies with R&D investment of more than 100 million yuan, Kangyuan Pharmaceutical, Yiling Pharmaceutical, Tasly, China Resources Sanjiu and other companies have the highest R&D investment and proportion
.
Among them, Kangyuan Pharmaceutical has invested 465 million yuan, 395 million yuan and 501 million yuan in research and development in the past three years, and research and development investment accounted for more than 10% of its revenue
.
Table 1: Some listed Chinese medicine companies with R&D investment of over 100 million yuan (data source: annual report) CDE data shows that in 2021, CDE accepted a total of about 1,360 Chinese medicine applications, including 60 new drug applications, an increase of 32 applications compared with 2020.
An increase of 114.
29%
.
According to the official website of the State Food and Drug Administration, a total of 17 new Chinese medicines have been approved for marketing from 2019 to 2021
.
Among them, 12 new Chinese medicine drugs will be approved in 2021, the highest number of approvals in recent years
.
Specific to related companies, from 2019 to 2021, Yiling Pharmaceutical has a total of 3 new Chinese medicines approved for listing, and Tasly and Kangyuan Pharmaceutical have respectively 2 approved, ranking among the top companies in the number of approved drugs
.
It can be seen that the amount of R&D investment not only represents the core competitiveness of an enterprise, but also is proportional to technological innovation and output
.
Despite the high investment, the listing of new Chinese medicines has also brought considerable commercial profits to the company
.
Take Yiling Pharmaceutical's Lianhua Qingke Tablets as an example.
In May 2020, the drug obtained the approval for drug registration, and passed the medical insurance negotiation at the end of the year, and was included in the 2020 version of the National Medical Insurance Catalog for the first time
.
According to data from Minet.
com, in the first half of 2021, the sales of Lianhua Qingke Tablets in public medical institutions in China reached 2.
11 million yuan, and commercial returns are gradually emerging
.
Convergence of the track, "overtaking on the curve" in the field of differentiated treatment In the context of the gradual increase in the innovation strength of Chinese medicine companies, it is more important to correctly choose the "track" for new drug research and development
.
From the perspective of drug classification, the new traditional Chinese medicines that have been launched in the past five years mainly focus on the advantages and characteristics of traditional Chinese medicine treatment fields such as cardiovascular and cerebrovascular, respiratory, digestive, endocrine, women and children, and the research and development of new traditional Chinese medicines is relatively concentrated
.
At the same time, a reporter from the "Medical Economic News" found that most Chinese medicine companies tend to be homogenized in the field of drug research and development, and the innovation attribute is not obvious
.
For example, from the perspective of drug use, among the 60 new drug applications of traditional Chinese medicine accepted by CDE in 2021, digestive system, respiratory system, and cardiovascular and cerebrovascular diseases are still the top three drug fields of new drug applications for traditional Chinese medicine
.
According to Deng Yong, a researcher at the National Institute of Traditional Chinese Medicine Development and Strategy, Beijing University of Traditional Chinese Medicine, the core competitiveness of new traditional Chinese medicine research and development needs to be further improved, including the patented technical value and commercial value of prescriptions
.
In response to the situation of multiple varieties of new drugs under research in traditional Chinese medicine with the same disease, some companies have begun to adjust the track and pay more attention to differentiated innovation
.
In the 2021 annual report, Kangyuan Pharmaceutical mentioned that in terms of new drugs under research in traditional Chinese medicine, in 2022, it will accelerate the establishment and research and development of drugs for pediatrics, cardiovascular, geriatrics and metabolic diseases, expand new clinical fields, and adjust clinical promotion strategies.
The output of new drugs forms a continuous output capability
.
And strengthen the research on the cultivation of key medical insurance or basic drugs that have been listed in traditional Chinese medicine.
Among them, the research and development investment of Jinzhen Oral Liquid Project, Maxing Zhixiao Granules Project, and Zixin Biqiu Granules project amounted to 12.
0716 million yuan, 10.
2309 million yuan and 6.
3973 million yuan respectively.
10,000 yuan, and the total R&D investment accounted for 0.
79% of the operating income
.
In addition, traditional Chinese medicine companies such as Buchang Pharmaceutical, Yiling Pharmaceutical, and Kangyuan Pharmaceutical have also opened up business lines such as innovative chemical drugs, biological drugs, and vaccines
.
As of the first half of 2021, Yiling Pharmaceutical has 4 first-class innovative drug varieties entering the clinical stage, and several first-class innovative drugs are in the preclinical research stage
.
Among them, Aniprofen Injection, a non-steroidal analgesic and anti-inflammatory drug used for postoperative pain patients, has entered Phase III clinical trials
.
In 2021, CR Sanjiu will have 71 research projects, mainly focusing on oncology, orthopedics, skin, respiratory, anti-infection and other fields, combining imitation and innovation to carry out product layout
.
Table 2: Research and development of new chemical drugs in Yiling Pharmaceutical (Data source: corporate annual report) Internal and external training, diversified layout, breaking through the "gene background" limitation of traditional Chinese medicine However, for most enterprises, even if the awareness of new traditional Chinese medicine research and development innovation Once awakened, we must keep abreast of changes in policy and industry environment, so that we can "take advantage of the wind and leverage"
.
However, it is not easy to adjust the strategic layout in time
.
A research and development staff of a domestic listed Chinese medicine company said frankly, "The 'gene background' of Chinese medicine is too strong, and it is very limited to do biological drug research and development in-house
.
If Chinese medicine companies want to break the bottleneck of performance growth and maintain a long-term stable development trend, it is urgently needed.
Enhance innovation awareness and make products more diversified
.
" With the advancement of a series of domestic medical reform policies, the pharmaceutical industry has accelerated its transformation and upgrading, and traditional Chinese medicine companies have transformed into innovative drugs and high-end generic drugs, which is also a major challenge to their research and development capabilities.
.
Some people in the industry also pointed out that from the perspective of the successful transformation of Chinese medicine companies in China, the company's persistence in R&D and innovation is inseparable
.
In recent years, some powerful traditional Chinese medicine companies have actively carried out international cooperation and development while accelerating the progress of innovation and research and development, and constantly deployed domestic and overseas markets, thereby enhancing their competitiveness and influence
.