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39 FDA、。、，，、，（MCL），（WM）。
、、，“”，“”，。，。
5，、、、，，。me too 、fast followme better/best、first in class，license inlicense out。“、”，“+”。
01
2019，。，。，，2009FDA。
，2017（ICH），，。FDA。
，2017201710。。。
，30，20，、I/IIAU003。20211，3100，2400。
，，20，40。，FDAFDA“”，“”、“”、“”。
，FDA。2016，FDA3，、。
FDA
2014，70，。20201935FDA，48；、43。
FDA2012，、。，。
20191，FDA，FDA。，。，7FDA。
FDA
：xevinapant，2011Debiopharma，318.
98
98
， FDA，FDA。，，、，。
（TGA），，FDA，TGA。，40%，。
，，，。
，，，“”。I、，，。
20148，，，。、，，，I，、II，II，、，。
，。，、、、，。
，/，，，，。
，20206NMPA，40%。202131，（64/）113006336。，60%～90%，，，。
02 “”
、、，，。，，“”，。
（license out）。，2017～2020license out39，2006～201610license out3。
TOP10，，license out，、、。
TOP10（）
TOP10，、。，1、，6.
5，15.
5，22。
5，15.
5，22。
，，，PD-1，，。2020，2021。
TOP10（）
The cooperation between local pharmaceutical companies and multinational giants not only demonstrates the comprehensive strength of local innovative drug companies, but also helps to accelerate the "going global" of domestic innovative drugs to serve more patients around the world.
From the perspective of cross-border transaction trends, it may become the norm for Chinese and foreign pharmaceutical companies to join forces to jointly develop domestic and international pharmaceutical markets.
From the perspective of cross-border transaction trends, it may become the norm for Chinese and foreign pharmaceutical companies to join forces to jointly develop domestic and international pharmaceutical markets.
03 Chinese new drugs go to sea, not only developed countries
The internationalization and globalization of Chinese pharmaceutical companies should be the general trend.
However, it needs to be clearly recognized that if you want to participate in the global competition in the development of innovative drugs, especially in mature markets such as the United States, Europe, and Japan, Chinese companies still have a comparative advantage in terms of operating income and R&D investment.
Big gap.
However, it needs to be clearly recognized that if you want to participate in the global competition in the development of innovative drugs, especially in mature markets such as the United States, Europe, and Japan, Chinese companies still have a comparative advantage in terms of operating income and R&D investment.
Big gap.
But from another point of view, most of the global top 10 pharmaceutical companies’ operating income comes from developed countries such as Europe, the United States, Japan, and South Korea, where the total population is less than 20%.
The income from emerging markets such as China still accounts for a relatively low proportion.
Because only economically developed countries can accommodate the relatively high price system of innovative drugs.
The income from emerging markets such as China still accounts for a relatively low proportion.
Because only economically developed countries can accommodate the relatively high price system of innovative drugs.
As China's pharmaceutical R&D strength continues to increase, many local pharmaceutical companies are actively deploying innovative drugs internationally.
In the future, there will be more domestic innovative drugs seeking to "go overseas.
" In addition to entering the mature markets of the United States and Europe, using the advantages of R&D costs to meet the needs of patients in underdeveloped countries is also a differentiated market opportunity that is worth exploring.
In the future, there will be more domestic innovative drugs seeking to "go overseas.
" In addition to entering the mature markets of the United States and Europe, using the advantages of R&D costs to meet the needs of patients in underdeveloped countries is also a differentiated market opportunity that is worth exploring.
How to benefit 80% of patients in the world outside of developed countries in Europe, America, Japan and South Korea with high quality? Zebutinib’s deployment strategy in more than 40 countries on five continents covers a wide range of developing countries including the UAE, Israel, Turkey, and Latin America and the Caribbean, the Middle East and North Africa.
This may also be an indication for industrial development.
A direction: Obtaining FDA approval is not the end of product development, but the starting point for its entry into other countries around the world, and its subsequent commercialization has a long way to go.
This may also be an indication for industrial development.
A direction: Obtaining FDA approval is not the end of product development, but the starting point for its entry into other countries around the world, and its subsequent commercialization has a long way to go.
Medical Network News, March 9th Zebutinib is China's first domestically developed anti-cancer drug to be approved by the FDA as a breakthrough therapy and the first domestically developed anti-cancer drug approved in the United States.
After being approved successively in the United States and China, the drug has recently reported good news.
The UAE and Canada have approved the new drug application for Zebutinib for the treatment of relapsed and refractory mantle cell lymphoma (MCL).
And the treatment of Waldenstrom's macroglobulinemia (WM).
After being approved successively in the United States and China, the drug has recently reported good news.
The UAE and Canada have approved the new drug application for Zebutinib for the treatment of relapsed and refractory mantle cell lymphoma (MCL).
And the treatment of Waldenstrom's macroglobulinemia (WM).
After successively obtaining marketing authorizations from the United States, China, the United Arab Emirates and Canada, Zebutinib has been "going abroad" continuously, which also proves that the ideal of "letting Chinese new drugs go abroad" is not a foolish dream, but a practical goal.
Zebutinib's achievements are not only inseparable from BeiGene's own years of hard work, but also inseparable from the opportunities given by the times.
Zebutinib's achievements are not only inseparable from BeiGene's own years of hard work, but also inseparable from the opportunities given by the times.
Especially in the past five years or so, under the multiple benefits of policy encouragement, capital blessing, talent return, and technology promotion, the development of China's innovative medicine industry has reached a new height, and domestic pharmaceutical companies are developing iteratively at an unprecedented speed.
The innovative connotation of drug research and development has also advanced from me too and fast follow to me better/best and first in class.
Project cooperation with overseas companies also has a good situation where license in and license out complement each other.
As "based on China and facing the world" has become the development vision of more and more local innovative drug companies, "independent development + authorized cooperation" has also become an important strategy for the internationalization of innovative drugs.
The innovative connotation of drug research and development has also advanced from me too and fast follow to me better/best and first in class.
Project cooperation with overseas companies also has a good situation where license in and license out complement each other.
As "based on China and facing the world" has become the development vision of more and more local innovative drug companies, "independent development + authorized cooperation" has also become an important strategy for the internationalization of innovative drugs.
01The internationalization of China's innovative drugs is advancing steadily
Before 2019, no innovative drug independently developed by a Chinese company entered the international market.
Even for early clinical registration and trial research, few Chinese pharmaceutical companies choose to go to Europe and the United States for simultaneous development.
Public information shows that the earliest application for clinical research of a new drug in China and the United States is repagliptin phosphate.
Hengrui Medicine submitted a clinical research application to the FDA in 2009 and was approved.
Even for early clinical registration and trial research, few Chinese pharmaceutical companies choose to go to Europe and the United States for simultaneous development.
Public information shows that the earliest application for clinical research of a new drug in China and the United States is repagliptin phosphate.
Hengrui Medicine submitted a clinical research application to the FDA in 2009 and was approved.
Thanks to the acceleration of the reform of China's drug review and approval system, especially after China became a full member of the International Human Drug Registration Technology Coordination Council (ICH) in 2017 , local pharmaceutical companies have actively explored the international market.
Synchronous development becomes the focus.
More and more Chinese companies submit clinical research application materials to the FDA.
Synchronous development becomes the focus.
More and more Chinese companies submit clinical research application materials to the FDA.
According to incomplete statistics, the number of clinical approvals in the Sino-US Shuangbao after 2017 has increased by nearly 10 times compared with before 2017.
And in the past two or three years, several local pharmaceutical companies have begun to experiment with international multi-center clinical research.
The steady progress of the international registration of Chinese innovative drug products represented by Zebutinib is a typical example.
And in the past two or three years, several local pharmaceutical companies have begun to experiment with international multi-center clinical research.
The steady progress of the international registration of Chinese innovative drug products represented by Zebutinib is a typical example.
Public information shows that Zebutinib has carried out nearly 30 clinical trials around the world, including more than 20 global clinical trials.
One of the data used in the US application comes from an open, multi-center phase I/II Clinical trial AU003 study.
As of January 2021, there are more than 3100 patients enrolled in Zebutinib, of which more than 2,400 patients are from overseas.
One of the data used in the US application comes from an open, multi-center phase I/II Clinical trial AU003 study.
As of January 2021, there are more than 3100 patients enrolled in Zebutinib, of which more than 2,400 patients are from overseas.
At the same time, in addition to the four countries that have been approved, Zebutinib has also submitted more than 20 related listing applications worldwide, covering more than 40 countries and regions on five continents.
With good clinical data performance, Zebutinib has repeatedly obtained the FDA’s “orphan drug” qualification, as well as qualifications such as “fast track”, “breakthrough therapy”, and “priority review” before FDA approval.
With good clinical data performance, Zebutinib has repeatedly obtained the FDA’s “orphan drug” qualification, as well as qualifications such as “fast track”, “breakthrough therapy”, and “priority review” before FDA approval.
In addition to the continuous surge in the number of dual reports in China and the United States, Chinese pharmaceutical companies have also increased their efforts to seek orphan drug certification from the FDA in recent years.
As early as 2016, Zebutinib obtained three orphan drug qualifications granted by the FDA for the treatment of mantle cell lymphoma, Waldenstrom's macroglobulinemia and chronic lymphocytic leukemia.
As early as 2016, Zebutinib obtained three orphan drug qualifications granted by the FDA for the treatment of mantle cell lymphoma, Waldenstrom's macroglobulinemia and chronic lymphocytic leukemia.
Number of Chinese pharmaceutical companies awarded FDA orphan drug designation
Since 2014, Chinese pharmaceutical companies have obtained more than 70 orphan drug qualifications, and their number has shown a spurt of growth.
In particular, in 2020, a total of 19 Chinese companies have obtained 35 FDA orphan drug qualifications.
Ascent Pharmaceuticals has obtained 8 orphan drug qualifications with 4 drug capsules as the biggest winner; BeiGene and Junshi Biologics have 4 and 3 respectively.
This is the second place.
In particular, in 2020, a total of 19 Chinese companies have obtained 35 FDA orphan drug qualifications.
Ascent Pharmaceuticals has obtained 8 orphan drug qualifications with 4 drug capsules as the biggest winner; BeiGene and Junshi Biologics have 4 and 3 respectively.
This is the second place.
The breakthrough therapy certification channel was established by the FDA in 2012 to speed up the development and registration process of drugs that are used to treat serious diseases and show good efficacy in the early clinical development stage.
Obtaining a breakthrough therapy designation generally means that the drug has a high level of innovation, and it is very likely to bring major changes to the clinical treatment practice of a certain disease in the future.
Obtaining a breakthrough therapy designation generally means that the drug has a high level of innovation, and it is very likely to bring major changes to the clinical treatment practice of a certain disease in the future.
In January 2019, the FDA granted Zebutinib a breakthrough therapy designation.
This is the first time the FDA has granted this designation to a new Chinese drug.
The award of this certification marks an important step for Chinese new drugs in the process of going global.
So far, seven Chinese innovative drugs have obtained the FDA's breakthrough therapy qualification.
This is the first time the FDA has granted this designation to a new Chinese drug.
The award of this certification marks an important step for Chinese new drugs in the process of going global.
So far, seven Chinese innovative drugs have obtained the FDA's breakthrough therapy qualification.
China's innovative drug approved by the FDA as a breakthrough therapy
Note: xevinapant was first developed by Yasheng Pharmaceutical's predecessor, Yasheng, and was transferred to Debiopharma in 2011.
Merck, Germany, introduced the global rights and interests of the drug at 898 million euros on March 1.
Merck, Germany, introduced the global rights and interests of the drug at 898 million euros on March 1.
For a long time, FDA approval has been regarded as a global passport, and many international pharmaceutical companies have pursued FDA approval as the highest honor and guarantee of product quality.
China's innovative drugs want to go out, want to enter the international market, go overseas to carry out clinical trials, and obtain approval from overseas regulatory agencies, which is a key step.
China's innovative drugs want to go out, want to enter the international market, go overseas to carry out clinical trials, and obtain approval from overseas regulatory agencies, which is a key step.
The Australian Drug Administration (TGA) adopts a filing system for pre-clinical requirements.
As long as the data on animal experiments is good, even if some of the data is not complete enough to meet the FDA's requirements, pharmaceutical companies can go to TGA to declare and start the project first.
In addition, Australia has more than 40% of the research and development expenses refunded, which can reduce the research and development burden of pharmaceutical companies.
As long as the data on animal experiments is good, even if some of the data is not complete enough to meet the FDA's requirements, pharmaceutical companies can go to TGA to declare and start the project first.
In addition, Australia has more than 40% of the research and development expenses refunded, which can reduce the research and development burden of pharmaceutical companies.
For some tumor immunotherapies, it is difficult for animal experiment data to play a better predictive and reference significance.
If the earlier it can enter human trials, the more positive it will be for the subsequent development of the product.
If the earlier it can enter human trials, the more positive it will be for the subsequent development of the product.
In order to shorten the time to market and reduce development costs, many Chinese innovative pharmaceutical companies have chosen Australia for their "first show" during their overseas clinical trials.
They will present the Phase I clinical trial data obtained in Australia to regulatory agencies in Japan, the United States and even China to achieve rolling development and improve efficiency.
They will present the Phase I clinical trial data obtained in Australia to regulatory agencies in Japan, the United States and even China to achieve rolling development and improve efficiency.
In August 2014, Zebutinib launched the first human clinical trial in Australia, and used this data to conduct a Sino-US double report, speeding up the pace of confirming trials in China and the United States.
Yan Xiaojun, senior vice president of BeiGene and head of global pharmaceutical affairs, once introduced that in the early stage of the clinical trial of Zebutinib, the BeiGene team proposed innovative strategies and supported China and the United States through Phase I clinical data in Australia.
Phase II clinical trials and key clinical trials, and later passed China’s key phase II clinical trial data, which further supported the marketing applications and approvals in the United States, China, and subsequent countries.
Yan Xiaojun, senior vice president of BeiGene and head of global pharmaceutical affairs, once introduced that in the early stage of the clinical trial of Zebutinib, the BeiGene team proposed innovative strategies and supported China and the United States through Phase I clinical data in Australia.
Phase II clinical trials and key clinical trials, and later passed China’s key phase II clinical trial data, which further supported the marketing applications and approvals in the United States, China, and subsequent countries.
Going overseas to carry out clinical trials of new drugs is also becoming a trend among Chinese innovative pharmaceutical companies.
In addition to BeiGene, there are many pharmaceutical companies such as Junshi Bio, Corning Jereh, CStone Pharmaceuticals, Fuhong Hanlius, etc.
, eager to try, and have successively launched clinical trials overseas.
In addition to BeiGene, there are many pharmaceutical companies such as Junshi Bio, Corning Jereh, CStone Pharmaceuticals, Fuhong Hanlius, etc.
, eager to try, and have successively launched clinical trials overseas.
In general, the international multi-center clinical research carried out by borrowing the policy dividends of different countries/regions can not only use low cost to open the door to foreign markets, but also reduce the marginal cost of products as its market area and coverage of indications continue to expand.
, So as to serve patients at a more affordable price.
, So as to serve patients at a more affordable price.
In China, Zebutinib was approved by the NMPA in June 2020 and was included in the national medical insurance at a price cut of more than 40% six months later.
With the official implementation of the new version of the National Medical Insurance Catalogue on March 1, 2021, the domestic market price of Zebutinib has dropped from RMB 11,300 per box (64 tablets/box) to the medical insurance price of RMB 6,336.
If combined with the reimbursement ratios in different regions, the monthly out-of-pocket expenses of patients will be further reduced by about 60% to 90% on this basis, which greatly reduces the burden of treatment for patients and allows domestic patients to benefit from medical insurance prices that are close to the people.
Innovative treatment plan based on international quality.
With the official implementation of the new version of the National Medical Insurance Catalogue on March 1, 2021, the domestic market price of Zebutinib has dropped from RMB 11,300 per box (64 tablets/box) to the medical insurance price of RMB 6,336.
If combined with the reimbursement ratios in different regions, the monthly out-of-pocket expenses of patients will be further reduced by about 60% to 90% on this basis, which greatly reduces the burden of treatment for patients and allows domestic patients to benefit from medical insurance prices that are close to the people.
Innovative treatment plan based on international quality.
02Another Path for Innovative Drugs to "Go Global"
Driven by multiple factors such as the policy environment, industrial capital, and technological progress, domestically produced innovative drugs have entered the golden period of development and become a long-term track with a strong moat.
With the ability to innovate and improve local pharmaceutical companies, as well as foreign enterprises gradually recognized for the innovative strength of local pharmaceutical companies, by authorizing cooperation "going out", the pharmaceutical sector has gradually become the common way.
With the ability to innovate and improve local pharmaceutical companies, as well as foreign enterprises gradually recognized for the innovative strength of local pharmaceutical companies, by authorizing cooperation "going out", the pharmaceutical sector has gradually become the common way.
The increasing number of transactions involving domestic biopharmaceutical companies' licensing (license out) projects to overseas companies can also be regarded as one of the landmark events of the substantial increase in the strength of China's pharmaceutical industry.
According to incomplete statistics from Medical Rubik's Cube, there have been 39 cases of external license outs of Chinese biopharmaceutical companies from 2017 to 2020, which is three times the number of license out transactions in the 10 years from 2006 to 2016.
According to incomplete statistics from Medical Rubik's Cube, there have been 39 cases of external license outs of Chinese biopharmaceutical companies from 2017 to 2020, which is three times the number of license out transactions in the 10 years from 2006 to 2016.
Judging from the first payment of TOP10 innovative drug transactions, except for the biosimilar drug of Trastuzumab from Fuhong Henlius, the remaining license out projects are mainly innovative monoclonal antibody projects and cell therapies, and Johnson & Johnson is among the transferees.
, Novartis, Eli Lilly and other multinational giants.
, Novartis, Eli Lilly and other multinational giants.
TOP10 foreign project licenses for Chinese pharmaceutical companies (based on down payment)
From the perspective of the TOP10 innovative drug transactions in terms of total transaction volume, the transactions between BeiGene, Tianjing Biological and multinational pharmaceutical companies are constantly setting new records.
In the first place, BeiGene and the global pharmaceutical giant Novartis reached a cooperation and licensing agreement in January this year for the development, production and commercialization of ralizumab in multiple countries.
The advance payment is US$650 million and the milestone payment For 1.
55 billion U.
S.
dollars, the total transaction value exceeds 2.
2 billion U.
S.
dollars.
In the first place, BeiGene and the global pharmaceutical giant Novartis reached a cooperation and licensing agreement in January this year for the development, production and commercialization of ralizumab in multiple countries.
The advance payment is US$650 million and the milestone payment For 1.
55 billion U.
S.
dollars, the total transaction value exceeds 2.
2 billion U.
S.
dollars.
Dr.
Wu Xiaobin, President of BeiGene, once introduced in an interview that the cooperation between BeiGene and Novartis not only represents the recognition of the quality of domestic innovative drugs by international pharmaceutical giants, but also the globalization of PD-1 and the long-term exploration in combination therapy.
, Has brought a broader possibility.
According to BeiGene's 2020 financial report, tislelizumab plans to submit its first new drug listing application in overseas markets in 2021.
Wu Xiaobin, President of BeiGene, once introduced in an interview that the cooperation between BeiGene and Novartis not only represents the recognition of the quality of domestic innovative drugs by international pharmaceutical giants, but also the globalization of PD-1 and the long-term exploration in combination therapy.
, Has brought a broader possibility.
According to BeiGene's 2020 financial report, tislelizumab plans to submit its first new drug listing application in overseas markets in 2021.
TOP10 foreign project licenses of Chinese pharmaceutical companies (according to the total amount of transactions)
The cooperation between local pharmaceutical companies and multinational giants not only demonstrates the comprehensive strength of local innovative drug companies, but also helps to accelerate the "going global" of domestic innovative drugs to serve more patients around the world.
From the perspective of cross-border transaction trends, it may become the norm for Chinese and foreign pharmaceutical companies to join forces to jointly develop domestic and international pharmaceutical markets.
From the perspective of cross-border transaction trends, it may become the norm for Chinese and foreign pharmaceutical companies to join forces to jointly develop domestic and international pharmaceutical markets.
03 Chinese new drugs go to sea, not only developed countries
The internationalization and globalization of Chinese pharmaceutical companies should be the general trend.
However, it needs to be clearly recognized that if you want to participate in the global competition in the development of innovative drugs, especially in mature markets such as the United States, Europe, and Japan, Chinese companies still have a comparative advantage in terms of operating income and R&D investment.
Big gap.
However, it needs to be clearly recognized that if you want to participate in the global competition in the development of innovative drugs, especially in mature markets such as the United States, Europe, and Japan, Chinese companies still have a comparative advantage in terms of operating income and R&D investment.
Big gap.
But from another point of view, most of the global top 10 pharmaceutical companies’ operating income comes from developed countries such as Europe, the United States, Japan, and South Korea, where the total population is less than 20%.
The income from emerging markets such as China still accounts for a relatively low proportion.
Because only economically developed countries can accommodate the relatively high price system of innovative drugs.
The income from emerging markets such as China still accounts for a relatively low proportion.
Because only economically developed countries can accommodate the relatively high price system of innovative drugs.
As China's pharmaceutical R&D strength continues to increase, many local pharmaceutical companies are actively deploying innovative drugs internationally.
In the future, there will be more domestic innovative drugs seeking to "go overseas.
" In addition to entering the mature markets of the United States and Europe, using the advantages of R&D costs to meet the needs of patients in underdeveloped countries is also a differentiated market opportunity that is worth exploring.
In the future, there will be more domestic innovative drugs seeking to "go overseas.
" In addition to entering the mature markets of the United States and Europe, using the advantages of R&D costs to meet the needs of patients in underdeveloped countries is also a differentiated market opportunity that is worth exploring.
How to benefit 80% of patients in the world outside of developed countries in Europe, America, Japan and South Korea with high quality? Zebutinib’s deployment strategy in more than 40 countries on five continents covers a wide range of developing countries including the UAE, Israel, Turkey, and Latin America and the Caribbean, the Middle East and North Africa.
This may also be an indication for industrial development.
A direction: Obtaining FDA approval is not the end of product development, but the starting point for its entry into other countries around the world, and its subsequent commercialization has a long way to go.
This may also be an indication for industrial development.
A direction: Obtaining FDA approval is not the end of product development, but the starting point for its entry into other countries around the world, and its subsequent commercialization has a long way to go.
Medical Network News, March 9th Zebutinib is China's first domestically developed anti-cancer drug to be approved by the FDA as a breakthrough therapy and the first domestically developed anti-cancer drug approved in the United States.
After being approved successively in the United States and China, the drug has recently reported good news.
The UAE and Canada have approved the new drug application for Zebutinib for the treatment of relapsed and refractory mantle cell lymphoma (MCL).
And the treatment of Waldenstrom's macroglobulinemia (WM).
After being approved successively in the United States and China, the drug has recently reported good news.
The UAE and Canada have approved the new drug application for Zebutinib for the treatment of relapsed and refractory mantle cell lymphoma (MCL).
And the treatment of Waldenstrom's macroglobulinemia (WM).
After successively obtaining marketing authorizations from the United States, China, the United Arab Emirates and Canada, Zebutinib has been "going abroad" continuously, which also proves that the ideal of "letting Chinese new drugs go abroad" is not a foolish dream, but a practical goal.
Zebutinib's achievements are not only inseparable from BeiGene's own years of hard work, but also inseparable from the opportunities given by the times.
Zebutinib's achievements are not only inseparable from BeiGene's own years of hard work, but also inseparable from the opportunities given by the times.
Especially in the past five years or so, under the multiple benefits of policy encouragement, capital blessing, talent return, and technology promotion, the development of China's innovative medicine industry has reached a new height, and domestic pharmaceutical companies are developing iteratively at an unprecedented speed.
The innovative connotation of drug research and development has also advanced from me too and fast follow to me better/best and first in class.
Project cooperation with overseas companies also has a good situation where license in and license out complement each other.
As "based on China and facing the world" has become the development vision of more and more local innovative drug companies, "independent development + authorized cooperation" has also become an important strategy for the internationalization of innovative drugs.
Talent Talent TalentThe innovative connotation of drug research and development has also advanced from me too and fast follow to me better/best and first in class.
Project cooperation with overseas companies also has a good situation where license in and license out complement each other.
As "based on China and facing the world" has become the development vision of more and more local innovative drug companies, "independent development + authorized cooperation" has also become an important strategy for the internationalization of innovative drugs.
01The internationalization of China's innovative drugs is advancing steadily
01The internationalization of China's innovative drugs is advancing steadily Before 2019, no innovative drug independently developed by a Chinese company entered the international market.
Even for early clinical registration and trial research, few Chinese pharmaceutical companies choose to go to Europe and the United States for simultaneous development.
Public information shows that the earliest application for clinical research of a new drug in China and the United States is repagliptin phosphate.
Hengrui Medicine submitted a clinical research application to the FDA in 2009 and was approved.
Even for early clinical registration and trial research, few Chinese pharmaceutical companies choose to go to Europe and the United States for simultaneous development.
Public information shows that the earliest application for clinical research of a new drug in China and the United States is repagliptin phosphate.
Hengrui Medicine submitted a clinical research application to the FDA in 2009 and was approved.
Thanks to the acceleration of the reform of China's drug review and approval system, especially after China became a full member of the International Human Drug Registration Technology Coordination Council (ICH) in 2017 , local pharmaceutical companies have actively explored the international market.
Synchronous development becomes the focus.
More and more Chinese companies submit clinical research application materials to the FDA.
Drugs Drugs Drugs Drug Registration Drug Registration Drug RegistrationSynchronous development becomes the focus.
More and more Chinese companies submit clinical research application materials to the FDA.
According to incomplete statistics, the number of clinical approvals in the Sino-US Shuangbao after 2017 has increased by nearly 10 times compared with before 2017.
And in the past two or three years, several local pharmaceutical companies have begun to experiment with international multi-center clinical research.
The steady progress of the international registration of Chinese innovative drug products represented by Zebutinib is a typical example.
And in the past two or three years, several local pharmaceutical companies have begun to experiment with international multi-center clinical research.
The steady progress of the international registration of Chinese innovative drug products represented by Zebutinib is a typical example.
Public information shows that Zebutinib has carried out nearly 30 clinical trials around the world, including more than 20 global clinical trials.
One of the data used in the US application comes from an open, multi-center phase I/II Clinical trial AU003 study.
As of January 2021, there are more than 3100 patients enrolled in Zebutinib, of which more than 2,400 patients are from overseas.
One of the data used in the US application comes from an open, multi-center phase I/II Clinical trial AU003 study.
As of January 2021, there are more than 3100 patients enrolled in Zebutinib, of which more than 2,400 patients are from overseas.
At the same time, in addition to the four countries that have been approved, Zebutinib has also submitted more than 20 related listing applications worldwide, covering more than 40 countries and regions on five continents.
With good clinical data performance, Zebutinib has repeatedly obtained the FDA’s “orphan drug” qualification, as well as qualifications such as “fast track”, “breakthrough therapy”, and “priority review” before FDA approval.
With good clinical data performance, Zebutinib has repeatedly obtained the FDA’s “orphan drug” qualification, as well as qualifications such as “fast track”, “breakthrough therapy”, and “priority review” before FDA approval.
In addition to the continuous surge in the number of dual reports in China and the United States, Chinese pharmaceutical companies have also increased their efforts to seek orphan drug certification from the FDA in recent years.
As early as 2016, Zebutinib obtained three orphan drug qualifications granted by the FDA for the treatment of mantle cell lymphoma, Waldenstrom's macroglobulinemia and chronic lymphocytic leukemia.
As early as 2016, Zebutinib obtained three orphan drug qualifications granted by the FDA for the treatment of mantle cell lymphoma, Waldenstrom's macroglobulinemia and chronic lymphocytic leukemia.
Number of Chinese pharmaceutical companies awarded FDA orphan drug designation
Since 2014, Chinese pharmaceutical companies have obtained more than 70 orphan drug qualifications, and their number has shown a spurt of growth.
In particular, in 2020, a total of 19 Chinese companies have obtained 35 FDA orphan drug qualifications.
Ascent Pharmaceuticals has obtained 8 orphan drug qualifications with 4 drug capsules as the biggest winner; BeiGene and Junshi Biologics have 4 and 3 respectively.
This is the second place.
Medicine Medicine MedicineIn particular, in 2020, a total of 19 Chinese companies have obtained 35 FDA orphan drug qualifications.
Ascent Pharmaceuticals has obtained 8 orphan drug qualifications with 4 drug capsules as the biggest winner; BeiGene and Junshi Biologics have 4 and 3 respectively.
This is the second place.
The breakthrough therapy certification channel was established by the FDA in 2012 to speed up the development and registration process of drugs that are used to treat serious diseases and show good efficacy in the early clinical development stage.
Obtaining a breakthrough therapy designation generally means that the drug has a high level of innovation, and it is very likely to bring major changes to the clinical treatment practice of a certain disease in the future.
Obtaining a breakthrough therapy designation generally means that the drug has a high level of innovation, and it is very likely to bring major changes to the clinical treatment practice of a certain disease in the future.
In January 2019, the FDA granted Zebutinib a breakthrough therapy designation.
This is the first time the FDA has granted this designation to a new Chinese drug.
The award of this certification marks an important step for Chinese new drugs in the process of going global.
So far, seven Chinese innovative drugs have obtained the FDA's breakthrough therapy qualification.
This is the first time the FDA has granted this designation to a new Chinese drug.
The award of this certification marks an important step for Chinese new drugs in the process of going global.
So far, seven Chinese innovative drugs have obtained the FDA's breakthrough therapy qualification.
China's innovative drug approved by the FDA as a breakthrough therapy
Note: xevinapant was first developed by Yasheng Pharmaceutical's predecessor, Yasheng, and was transferred to Debiopharma in 2011.
Merck, Germany, introduced the global rights and interests of the drug at 898 million euros on March 1.
Merck, Germany, introduced the global rights and interests of the drug at 898 million euros on March 1.
For a long time, FDA approval has been regarded as a global passport, and many international pharmaceutical companies have pursued FDA approval as the highest honor and guarantee of product quality.
China's innovative drugs want to go out, want to enter the international market, go overseas to carry out clinical trials, and obtain approval from overseas regulatory agencies, which is a key step.
China's innovative drugs want to go out, want to enter the international market, go overseas to carry out clinical trials, and obtain approval from overseas regulatory agencies, which is a key step.
The Australian Drug Administration (TGA) adopts a filing system for pre-clinical requirements.
As long as the data on animal experiments is good, even if some of the data is not complete enough to meet the FDA's requirements, pharmaceutical companies can go to TGA to declare and start the project first.
In addition, Australia has more than 40% of the research and development expenses refunded, which can reduce the research and development burden of pharmaceutical companies.
As long as the data on animal experiments is good, even if some of the data is not complete enough to meet the FDA's requirements, pharmaceutical companies can go to TGA to declare and start the project first.
In addition, Australia has more than 40% of the research and development expenses refunded, which can reduce the research and development burden of pharmaceutical companies.
For some tumor immunotherapies, it is difficult for animal experiment data to play a better predictive and reference significance.
If the earlier it can enter human trials, the more positive it will be for the subsequent development of the product.
If the earlier it can enter human trials, the more positive it will be for the subsequent development of the product.
In order to shorten the time to market and reduce development costs, many Chinese innovative pharmaceutical companies have chosen Australia for their "first show" during their overseas clinical trials.
They will present the Phase I clinical trial data obtained in Australia to regulatory agencies in Japan, the United States and even China to achieve rolling development and improve efficiency.
They will present the Phase I clinical trial data obtained in Australia to regulatory agencies in Japan, the United States and even China to achieve rolling development and improve efficiency.
In August 2014, Zebutinib launched the first human clinical trial in Australia, and used this data to conduct a Sino-US double report, speeding up the pace of confirming trials in China and the United States.
Yan Xiaojun, senior vice president of BeiGene and head of global pharmaceutical affairs, once introduced that in the early stage of the clinical trial of Zebutinib, the BeiGene team proposed innovative strategies and supported China and the United States through Phase I clinical data in Australia.
Phase II clinical trials and key clinical trials, and later passed China’s key phase II clinical trial data, which further supported the marketing applications and approvals in the United States, China, and subsequent countries.
Yan Xiaojun, senior vice president of BeiGene and head of global pharmaceutical affairs, once introduced that in the early stage of the clinical trial of Zebutinib, the BeiGene team proposed innovative strategies and supported China and the United States through Phase I clinical data in Australia.
Phase II clinical trials and key clinical trials, and later passed China’s key phase II clinical trial data, which further supported the marketing applications and approvals in the United States, China, and subsequent countries.
Going overseas to carry out clinical trials of new drugs is also becoming a trend among Chinese innovative pharmaceutical companies.
In addition to BeiGene, there are many pharmaceutical companies such as Junshi Bio, Corning Jereh, CStone Pharmaceuticals, Fuhong Hanlius, etc.
, eager to try, and have successively launched clinical trials overseas.
In addition to BeiGene, there are many pharmaceutical companies such as Junshi Bio, Corning Jereh, CStone Pharmaceuticals, Fuhong Hanlius, etc.
, eager to try, and have successively launched clinical trials overseas.
In general, the international multi-center clinical research carried out by borrowing the policy dividends of different countries/regions can not only use low cost to open the door to foreign markets, but also reduce the marginal cost of products as its market area and coverage of indications continue to expand.
, So as to serve patients at a more affordable price.
, So as to serve patients at a more affordable price.
In China, Zebutinib was approved by the NMPA in June 2020 and was included in the national medical insurance at a price cut of more than 40% six months later.
With the official implementation of the new version of the National Medical Insurance Catalogue on March 1, 2021, the domestic market price of Zebutinib has dropped from RMB 11,300 per box (64 tablets/box) to the medical insurance price of RMB 6,336.
If combined with the reimbursement ratios in different regions, the monthly out-of-pocket expenses of patients will be further reduced by about 60% to 90% on this basis, which greatly reduces the burden of treatment for patients and allows domestic patients to benefit from medical insurance prices that are close to the people.
Innovative treatment plan based on international quality.
With the official implementation of the new version of the National Medical Insurance Catalogue on March 1, 2021, the domestic market price of Zebutinib has dropped from RMB 11,300 per box (64 tablets/box) to the medical insurance price of RMB 6,336.
If combined with the reimbursement ratios in different regions, the monthly out-of-pocket expenses of patients will be further reduced by about 60% to 90% on this basis, which greatly reduces the burden of treatment for patients and allows domestic patients to benefit from medical insurance prices that are close to the people.
Innovative treatment plan based on international quality.
02Another Path for Innovative Drugs to "Go Global"
02Another Path for Innovative Drugs to "Go Global" Driven by multiple factors such as the policy environment, industrial capital, and technological progress, domestically produced innovative drugs have entered the golden period of development and become a long-term track with a strong moat.
With the ability to innovate and improve local pharmaceutical companies, as well as foreign enterprises gradually recognized for the innovative strength of local pharmaceutical companies, by authorizing cooperation "going out", the pharmaceutical sector has gradually become the common way.
Enterprise business enterpriseWith the ability to innovate and improve local pharmaceutical companies, as well as foreign enterprises gradually recognized for the innovative strength of local pharmaceutical companies, by authorizing cooperation "going out", the pharmaceutical sector has gradually become the common way.
The increasing number of transactions involving domestic biopharmaceutical companies' licensing (license out) projects to overseas companies can also be regarded as one of the landmark events of the substantial increase in the strength of China's pharmaceutical industry.
According to incomplete statistics from Medical Rubik's Cube, there have been 39 cases of external license outs of Chinese biopharmaceutical companies from 2017 to 2020, which is three times the number of license out transactions in the 10 years from 2006 to 2016.
According to incomplete statistics from Medical Rubik's Cube, there have been 39 cases of external license outs of Chinese biopharmaceutical companies from 2017 to 2020, which is three times the number of license out transactions in the 10 years from 2006 to 2016.
Judging from the first payment of TOP10 innovative drug transactions, except for the biosimilar drug of Trastuzumab from Fuhong Henlius, the remaining license out projects are mainly innovative monoclonal antibody projects and cell therapies, and Johnson & Johnson is among the transferees.
, Novartis, Eli Lilly and other multinational giants.
, Novartis, Eli Lilly and other multinational giants.
TOP10 foreign project licenses for Chinese pharmaceutical companies (based on down payment)
From the perspective of the TOP10 innovative drug transactions in terms of total transaction volume, the transactions between BeiGene, Tianjing Biological and multinational pharmaceutical companies are constantly setting new records.
In the first place, BeiGene and the global pharmaceutical giant Novartis reached a cooperation and licensing agreement in January this year for the development, production and commercialization of ralizumab in multiple countries.
The advance payment is US$650 million and the milestone payment For 1.
55 billion U.
S.
dollars, the total transaction value exceeds 2.
2 billion U.
S.
dollars.
In the first place, BeiGene and the global pharmaceutical giant Novartis reached a cooperation and licensing agreement in January this year for the development, production and commercialization of ralizumab in multiple countries.
The advance payment is US$650 million and the milestone payment For 1.
55 billion U.
S.
dollars, the total transaction value exceeds 2.
2 billion U.
S.
dollars.
Dr.
Wu Xiaobin, President of BeiGene, once introduced in an interview that the cooperation between BeiGene and Novartis not only represents the recognition of the quality of domestic innovative drugs by international pharmaceutical giants, but also the globalization of PD-1 and the long-term exploration in combination therapy.
, Has brought a broader possibility.
According to BeiGene's 2020 financial report, tislelizumab plans to submit its first new drug listing application in overseas markets in 2021.
Wu Xiaobin, President of BeiGene, once introduced in an interview that the cooperation between BeiGene and Novartis not only represents the recognition of the quality of domestic innovative drugs by international pharmaceutical giants, but also the globalization of PD-1 and the long-term exploration in combination therapy.
, Has brought a broader possibility.
According to BeiGene's 2020 financial report, tislelizumab plans to submit its first new drug listing application in overseas markets in 2021.
TOP10 foreign project licenses of Chinese pharmaceutical companies (according to the total amount of transactions)
The cooperation between local pharmaceutical companies and multinational giants not only demonstrates the comprehensive strength of local innovative drug companies, but also helps to accelerate the "going global" of domestic innovative drugs to serve more patients around the world.
From the perspective of cross-border transaction trends, it may become the norm for Chinese and foreign pharmaceutical companies to join forces to jointly develop domestic and international pharmaceutical markets.
From the perspective of cross-border transaction trends, it may become the norm for Chinese and foreign pharmaceutical companies to join forces to jointly develop domestic and international pharmaceutical markets.
03 Chinese new drugs go to sea, not only developed countries
03 Chinese new drugs go to sea, not only developed countries The internationalization and globalization of Chinese pharmaceutical companies should be the general trend.
However, it needs to be clearly recognized that if you want to participate in the global competition in the development of innovative drugs, especially in mature markets such as the United States, Europe, and Japan, Chinese companies still have a comparative advantage in terms of operating income and R&D investment.
Big gap.
However, it needs to be clearly recognized that if you want to participate in the global competition in the development of innovative drugs, especially in mature markets such as the United States, Europe, and Japan, Chinese companies still have a comparative advantage in terms of operating income and R&D investment.
Big gap.
But from another point of view, most of the global top 10 pharmaceutical companies’ operating income comes from developed countries such as Europe, the United States, Japan, and South Korea, where the total population is less than 20%.
The income from emerging markets such as China still accounts for a relatively low proportion.
Because only economically developed countries can accommodate the relatively high price system of innovative drugs.
The income from emerging markets such as China still accounts for a relatively low proportion.
Because only economically developed countries can accommodate the relatively high price system of innovative drugs.
As China's pharmaceutical R&D strength continues to increase, many local pharmaceutical companies are actively deploying innovative drugs internationally.
In the future, there will be more domestic innovative drugs seeking to "go overseas.
" In addition to entering the mature markets of the United States and Europe, using the advantages of R&D costs to meet the needs of patients in underdeveloped countries is also a differentiated market opportunity that is worth exploring.
In the future, there will be more domestic innovative drugs seeking to "go overseas.
" In addition to entering the mature markets of the United States and Europe, using the advantages of R&D costs to meet the needs of patients in underdeveloped countries is also a differentiated market opportunity that is worth exploring.
How to benefit 80% of patients in the world outside of developed countries in Europe, America, Japan and South Korea with high quality? Zebutinib’s deployment strategy in more than 40 countries on five continents covers a wide range of developing countries including the UAE, Israel, Turkey, and Latin America and the Caribbean, the Middle East and North Africa.
This may also be an indication for industrial development.
A direction: Obtaining FDA approval is not the end of product development, but the starting point for its entry into other countries around the world, and its subsequent commercialization has a long way to go.
This may also be an indication for industrial development.
A direction: Obtaining FDA approval is not the end of product development, but the starting point for its entry into other countries around the world, and its subsequent commercialization has a long way to go.
