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TCR refers to T cell receptor, which can guide T cells to recognize specific antigens.
Compared with CAR, TCR can recognize more target antigens, especially intracellular antigens, so it can be used in cell therapy for solid tumors that are difficult to overcome.
Play a role in the process and bring breakthroughs.
In the rapid development of TCR-T, what kind of technology and model domestic enterprises focusing on this field adopt, what challenges they face, and what policy and investment environment are the focus of this topic.
What kind of technologies and models do domestic companies focusing on this field adopt, what challenges they face, policies and investment environmentus" style="margin:0px;padding:0px;max-width:100%;box-sizing:border-box;color:#333333;font-size:16px;letter-spacing:0.
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At present, the global TCR-T development is in the clinical verification stage and is waiting for a breakthrough.
3 billion yuan to 10.
Place.
Efficient TCR screening and development is a common challenge in this field.
At present, the global TCR-T development is in the clinical verification stage and is waiting for a breakthrough.
5px;">The industry has always said that the gap between the development of Chinese cell therapy and the international advanced level is the smallest.
5px;">Why is cell therapy? There are many differences between cell therapy and traditional medicine, not only the difference in technology and mechanism.
Researchers interviewed some companies in this field and learned about their respective strategies and their observations and reflections on the industry, so as to understand what issues are common to China in this industry and what are the differences compared to the international ones.
8px;font-family:Optima-Regular, PingFangTC-light;">
544px;text-align:justify;background-color:#FFFFFF;font-family:Optima-Regular, PingFangTC-light;overflow-wrap:break-word ;">
In their view, the important opportunities for the development of this industry are largely derived from clinical resources and corresponding regulatory paths.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">Chen Xi, the founder of RootPath, said that a major feature of China in the field of cell therapy is that it is more grounded and non-dogmatic.
This is largely due to the relatively loose clinical trial environment.
And the path of supervision.
"Under this regulatory framework, the scientific research and clinical aspects of cell therapy are so active, which is more beneficial for early research.
"75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">According to observations and interviews by R&D customers, many domestic cell therapy development companies will choose to conduct IIT research first, and then gradually promote the submission of INDs and enter the drug approval path.
Seeking rapid conversion is obviously an important reason why companies adopt this strategy.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">The clinical experience of Tiankeya Biotechnology has confirmed the positive role of clinical resources in rapid transformation.
According to Su Zhenbo, co-founder of Tiankeya Bio, Tiankeya has started clinical trials in both China and the United States.
As China has more abundant clinical resources, clinical trials in China only require 1/8 to 1/5 of the funds and time of the United States.
can be completed.
It is a huge advantage for the cell therapy industry that needs to continuously verify innovation with clinical trials.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">When talking about China's cell therapy industry, several interviewees unanimously mentioned its advantages of "rapid transformation" .
In their view, the important opportunities for the development of this industry are largely derived from clinical resources and corresponding regulatory paths.
5px;">When talking about China's cell therapy industry, several interviewees unanimously mentioned its advantages of "rapid transformation" .
In their view, the important opportunities for the development of this industry are largely derived from clinical resources and corresponding regulatory paths.
"Quick Conversion"75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">Chen Xi, the founder of RootPath, said that a major feature of China in the field of cell therapy is that it is more grounded and non-dogmatic.
In China, investigators can initiate clinical (IIT) rapid and small-scale verification of innovative methods and ideas, and IIT can be applied for clinical approval before the drug regulatory approval.
This part of the data can also be included in the approval by the drug regulatory agency.
Speed up the clinical process.
In the United States, the initiation of IIT must be done after the clinical approval is obtained.
Under such differences, the development of China's cell therapy products has been iteratively fast.
( 5px;">RootPath has established R&D bases in China and the United States, and will interview this company in the next issue.
5px;"> )5px;">Chen Xi, the founder of RootPath, said that a major feature of China in the field of cell therapy is that it is more grounded and non-dogmatic.
In China, investigators can initiate clinical (IIT) rapid and small-scale verification of innovative methods and ideas, and IIT can be applied for clinical approval before the drug regulatory approval.
This part of the data can also be included in the approval by the drug regulatory agency.
Speed up the clinical process.
In the United States, the initiation of IIT must be done after the clinical approval is obtained.
Under such differences, the development of China's cell therapy products has been iteratively fast.
( 5px;">RootPath has established a research and development base in China and the United States, and will interview this company in the next issue.
5px;"> RootPath has established a research and development base in China and the United States, and will interview this company in the next issue.
5px;"> RootPath has established in China and the United States The research and development base has been established, and the company will be interviewed in the next issue.
5px;">)75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">5px;">75em;overflow-wrap:break-word ;">5px;">5px;">75em;overflow-wrap:break-word ;">5px;">Song Xiaodong, the co-founder of UTC and who has many years of registered work experience, believes that China's cell therapy clinical basic research is relatively developed and can keep pace with the United States, and the number of clinical trials even exceeds that of the United States.
This is largely due to the relatively loose clinical trial environment.
And the path of supervision.
"Under this regulatory framework, the scientific research and clinical aspects of cell therapy are so active, which is more beneficial for early research.
"5px;">Song Xiaodong, the co-founder of UTC and who has many years of registered work experience, believes that China's cell therapy clinical basic research is relatively developed and can keep pace with the United States, and the number of clinical trials even exceeds that of the United States.
This is largely due to the relatively loose clinical trial environment.
And the path of supervision.
"Under this regulatory framework, the scientific research and clinical aspects of cell therapy are so active, which is more beneficial for early research.
"75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">According to observations and interviews by R&D customers, many domestic cell therapy development companies will choose to conduct IIT research first, and then gradually promote the submission of INDs and enter the drug approval path.
Seeking rapid conversion is obviously an important reason why companies adopt this strategy.
5px;">According to observations and interviews by R&D customers, many domestic cell therapy development companies will choose to conduct IIT research first, and then gradually promote the submission of INDs and enter the drug approval path.
Seeking rapid conversion is obviously an important reason why companies adopt this strategy.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">The clinical experience of Tiankeya Biotechnology has confirmed the positive role of clinical resources in rapid transformation.
According to Su Zhenbo, co-founder of Tiankeya Bio, Tiankeya has started clinical trials in both China and the United States.
As China has more abundant clinical resources, clinical trials in China only require 1/8 to 1/5 of the funds and time of the United States.
can be completed.
It is a huge advantage for the cell therapy industry that needs to continuously verify innovation with clinical trials.
5px;">The clinical experience of Tiankeya Biotechnology has confirmed the positive role of clinical resources in rapid transformation.
According to Su Zhenbo, co-founder of Tiankeya Bio, Tiankeya has started clinical trials in both China and the United States.
As China has more abundant clinical resources, clinical trials in China only require 1/8 to 1/5 of the funds and time of the United States.
can be completed.
It is a huge advantage for the cell therapy industry that needs to continuously verify innovation with clinical trials.
75em;overflow-wrap:break-word ;">544px;background-color:#FFFFFF;text-align:center;line-height:1.
75em;overflow-wrap:break-word ;'>8px;font-family:Optima-Regular, PingFangTC-light;">
544px;text-align:justify;background-color:#FFFFFF;font-family:Optima-Regular, PingFangTC-light;overflow-wrap:break-word ;">
The Health Commission treats it as a medical technology supervision, and the National Medical Products Administration (NMPA) treats it as a drug supervision.
There are differences in the perception of its attributes.
The "dual track system" has triggered the industry The most discussion and controversy.
What kind of follow-up supervision will have a considerable impact on the development of enterprises and the industry is also a topic of great concern to enterprises.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">Chen Xi said that both the US FDA and the NMPA have recently released a good signal regarding the core issue of cell therapy properties, and they tend to treat the entire process as a drug for approval.
The CAR-T products that have been marketed in the United States are approved by drugs.
In China, there are also many CAR-Ts that have obtained clinical approvals.
The entire industry has reached the more favorable side of the watershed.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">In addition to attribute identification, another very important issue under the dual-track system is standards.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">Su Zhenbo told R&D customers that compared with new medical technology, drug supervision will have higher requirements and better standardization, and if the cell therapy industry wants to develop well, it must be more standardized and follow a more standardized approach to the end.
In fact, it will bring faster development speed.
"From our point of view, what the industry needs to improve most is that it needs to be more standardized to do this.
Strictly follow drug development, so that the entire industry can be made bigger.
"
.
He also raised a realistic question.
If clinical research on cell therapy is carried out under the framework of the National Health Commission, companies should consider as far as possible to carry out production and quality control in accordance with the quality requirements of the Phase I clinical or close to the Phase I clinical of the Food and Drug Administration.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">At some previous meetings, the Food and Drug Administration was also delivering such information that the data obtained by non-registered clinics must also meet the relevant requirements of the CDE before it may be used in the subsequent IND process.
The Food and Drug Administration has stricter quality control requirements for many of these details, and clearly requires that you follow the ideas of drug development, not scientific research.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">Mr.
Sai, a senior investor who has invested in many cell therapy companies and is very concerned about the field, said that because there are no good animal models or other non-clinical verification methods in this field, human research is a very important point for verifying innovation.
Therefore, they will introduce many invested companies to China, hoping to quickly carry out human research.
But in the process, he also found that supervision is now gradually tightening, and the supervisory department has become more prudent.
Under this trend, companies that are more detailed, more capable, and more resource-rich may have an advantage.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">However, the clinical path brings opportunities and risks.
The Health Commission treats it as a medical technology supervision, and the National Medical Products Administration (NMPA) treats it as a drug supervision.
There are differences in the perception of its attributes.
The "dual track system" has triggered the industry The most discussion and controversy.
What kind of follow-up supervision will have a considerable impact on the development of enterprises and the industry is also a topic of great concern to enterprises.
5px;">However, the clinical path brings opportunities and risks.
The Health Commission treats it as a medical technology supervision, and the National Medical Products Administration (NMPA) treats it as a drug supervision.
There are differences in the perception of its attributes.
The "dual track system" has triggered the industry The most discussion and controversy.
What kind of follow-up supervision will have a considerable impact on the development of enterprises and the industry is also a topic of great concern to enterprises.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">Chen Xi said that both the US FDA and the NMPA have recently released a good signal regarding the core issue of cell therapy properties, and they tend to treat the entire process as a drug for approval.
The CAR-T products that have been marketed in the United States are approved by drugs.
In China, there are also many CAR-Ts that have obtained clinical approvals.
The entire industry has reached the more favorable side of the watershed.
5px;">Chen Xi said that both the US FDA and the NMPA have recently released a good signal regarding the core issue of cell therapy properties, and they tend to treat the entire process as a drug for approval.
The CAR-T products that have been marketed in the United States are approved by drugs.
In China, there are also many CAR-Ts that have obtained clinical approvals.
The entire industry has reached the more favorable side of the watershed.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">In addition to attribute identification, another very important issue under the dual-track system is standards.
5px;">In addition to attribute identification, another very important issue under the dual-track system is standards.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">Su Zhenbo told R&D customers that compared with new medical technology, drug supervision will have higher requirements and better standardization, and if the cell therapy industry wants to develop well, it must be more standardized and follow a more standardized approach to the end.
In fact, it will bring faster development speed.
"From our point of view, what the industry needs to improve most is that it needs to be more standardized to do this.
Strictly follow drug development, so that the entire industry can be made bigger.
"5px;">Su Zhenbo told R&D customers that compared with new medical technology, drug supervision will have higher requirements and better standardization, and if the cell therapy industry wants to develop well, it must be more standardized and follow a more standardized approach to the end.
In fact, it will bring faster development speed.
"From our point of view, what the industry needs to improve most is that it needs to be more standardized to do this.
Strictly follow drug development, so that the entire industry can be made bigger.
"
.
He also raised a realistic question.
If clinical research on cell therapy is carried out under the framework of the National Health Commission, companies should consider as far as possible to carry out production and quality control in accordance with the quality requirements of the Phase I clinical or close to the Phase I clinical of the Food and Drug Administration.
5px;">Song Xiaodong believes that once cell therapy products are applied to the clinic or to patients, no matter what path is taken, they should follow the same standard, comply with the recently promulgated drug management measures, and follow the most rigorous standards and strict accountability.
.
He also raised a realistic question.
If clinical research on cell therapy is carried out under the framework of the National Health Commission, companies should consider as far as possible to carry out production and quality control in accordance with the quality requirements of the Phase I clinical or close to the Phase I clinical of the Food and Drug Administration.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">At some previous meetings, the Food and Drug Administration was also delivering such information that the data obtained by non-registered clinics must also meet the relevant requirements of the CDE before it may be used in the subsequent IND process.
The Food and Drug Administration has stricter quality control requirements for many of these details, and clearly requires that you follow the ideas of drug development, not scientific research.
5px;">At some previous meetings, the Food and Drug Administration was also delivering such information that the data obtained by non-registered clinics must also meet the relevant requirements of the CDE before it may be used in the subsequent IND process.
The Food and Drug Administration has stricter quality control requirements for many of these details, and clearly requires that you follow the ideas of drug development, not scientific research.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">Mr.
Sai, a senior investor who has invested in many cell therapy companies and is very concerned about the field, said that because there are no good animal models or other non-clinical verification methods in this field, human research is a very important point for verifying innovation.
Therefore, they will introduce many invested companies to China, hoping to quickly carry out human research.
But in the process, he also found that supervision is now gradually tightening, and the supervisory department has become more prudent.
Under this trend, companies that are more detailed, more capable, and more resource-rich may have an advantage.
5px;">Mr.
Sai, a senior investor who has invested in many cell therapy companies and is very concerned about the field, said that because there are no good animal models or other non-clinical verification methods in this field, human research is a very important point for verifying innovation.
Therefore, they will introduce many invested companies to China, hoping to quickly carry out human research.
But in the process, he also found that supervision is now gradually tightening, and the supervisory department has become more prudent.
Under this trend, companies that are more detailed, more capable, and more resource-rich may have an advantage.
75em;overflow-wrap:break-word ;">544px;background-color:#FFFFFF;text-align:center;line-height:1.
75em;overflow-wrap:break-word ;'>8px;font-family:Optima-Regular, PingFangTC-light;">
544px;text-align:justify;background-color:#FFFFFF;font-family:Optima-Regular, PingFangTC-light;overflow-wrap:break-word ;">
Sai’s observation, in China, cell therapy development companies are mainly divided into three categories: The first type of company is usually authorized by foreign countries to bring technology from the world.
This type of company has a certain reputation and has some progress; the second type The company also has some breakthroughs, mainly micro-innovation and micro-change; the third type of company may have some good technologies, but their innovation and team lack the ability to continue to do well, or to promote the product to the international level.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">Among them, companies with the ability to go overseas are the most valued by investors, and they are also an important consideration for his investment in cell therapy companies.
He explained that the greatest potential of cell therapy in the future lies in overseas markets, because overseas markets are large and medical insurance strategies are more suitable for cell therapy products.
The ability to go to overseas markets mainly measures whether the technology has the obvious advantages of global advancement, sufficient innovation and differentiation.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">In fact, most of the companies interviewed this time have initiated overseas deployments, including applying for clinical trials and setting up R&D centers in the United States, and most of their founding teams also have relevant work experience in the field of overseas cell therapy.
It can be said that taking China as the base point for rapid transformation and going international is an important strategy and trend.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">However, Su Zhenbo said that this strategy also has difficulties.
The clinical development in China and the United States will inevitably involve production problems.
Currently, cell drug production in the United States is still a pain point.
Many companies do not have production capacity in the United States and need to rely on CDMO.
When it comes to process issues, you need to wait in line, sometimes even two years.
Therefore, there are really not many companies capable of simultaneously conducting drug development, CMC and production, and clinical trials on both sides.
The consideration of speed is also one of the reasons why Tiankeya finally established a GMP production base in the United States.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">According to Mr.
Sai’s observation, in China, cell therapy development companies are mainly divided into three categories: The first type of company is usually authorized by foreign countries to bring technology from the world.
This type of company has a certain reputation and has some progress; the second type The company also has some breakthroughs, mainly micro-innovation and micro-change; the third type of company may have some good technologies, but their innovation and team lack the ability to continue to do well, or to promote the product to the international level.
5px;">According to Mr.
Sai’s observation, in China, cell therapy development companies are mainly divided into three categories: The first type of company is usually authorized by foreign countries to bring technology from the world.
This type of company has a certain reputation and has some progress; the second type The company also has some breakthroughs, mainly micro-innovation and micro-change; the third type of company may have some good technologies, but their innovation and team lack the ability to continue to do well, or to promote the product to the international level.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">Among them, companies with the ability to go overseas are the most valued by investors, and they are also an important consideration for his investment in cell therapy companies.
He explained that the greatest potential of cell therapy in the future lies in overseas markets, because overseas markets are large and medical insurance strategies are more suitable for cell therapy products.
The ability to go to overseas markets mainly measures whether the technology has the obvious advantages of global advancement, sufficient innovation and differentiation.
5px;">Among them, companies with the ability to go overseas are the most valued by investors, and they are also an important consideration for his investment in cell therapy companies.
He explained that the greatest potential of cell therapy in the future lies in overseas markets, because overseas markets are large and medical insurance strategies are more suitable for cell therapy products.
The ability to go to overseas markets mainly measures whether the technology has the obvious advantages of global advancement, sufficient innovation and differentiation.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">In fact, most of the companies interviewed this time have initiated overseas deployments, including applying for clinical trials and setting up R&D centers in the United States, and most of their founding teams also have relevant work experience in the field of overseas cell therapy.
It can be said that taking China as the base point for rapid transformation and going international is an important strategy and trend.
5px;">In fact, most of the companies interviewed this time have initiated overseas deployments, including applying for clinical trials and setting up R&D centers in the United States, and most of their founding teams also have relevant work experience in the field of overseas cell therapy.
It can be said that taking China as the base point for rapid transformation and going international is an important strategy and trend.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">However, Su Zhenbo said that this strategy also has difficulties.
The clinical development in China and the United States will inevitably involve production problems.
Currently, cell drug production in the United States is still a pain point.
Many companies do not have production capacity in the United States and need to rely on CDMO.
When it comes to process issues, you need to wait in line, sometimes even two years.
Therefore, there are really not many companies capable of simultaneously conducting drug development, CMC and production, and clinical trials on both sides.
The consideration of speed is also one of the reasons why Tiankeya finally established a GMP production base in the United States.
5px;">However, Su Zhenbo said that this strategy also has difficulties.
The clinical development in China and the United States will inevitably involve production problems.
Currently, cell drug production in the United States is still a pain point.
Many companies do not have production capacity in the United States and need to rely on CDMO.
When it comes to process issues, you need to wait in line, sometimes even two years.
Therefore, there are really not many companies capable of simultaneously conducting drug development, CMC and production, and clinical trials on both sides.
The consideration of speed is also one of the reasons why Tiankeya finally established a GMP production base in the United States.
75em;overflow-wrap:break-word ;">544px;background-color:#FFFFFF;text-align:center;line-height:1.
75em;overflow-wrap:break-word ;'>8px;font-family:Optima-Regular, PingFangTC-light;">
544px;text-align:justify;background-color:#FFFFFF;font-family:Optima-Regular, PingFangTC-light;overflow-wrap:break-word ;">
The two CAR-T products that have been on the market worldwide, Kymriah is priced at US$475,000 per course of treatment, and Yescarta is priced at US$373,000 per course of treatment.
The high price seems to have been regarded as a label for cell therapy.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">Regarding the changing trends of future costs and pricing, it is also a topic that every company pays close attention to in this interview.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">Chen Xi said that cell therapy includes two costs.
One is TCR discovery, which is research and development costs; the other is production costs.
High production costs, coupled with research and development costs, result in high final prices for such products.
However, this issue must be viewed from a developmental perspective.
The current high production cost lies in the fact that every link is not very efficient, and this part will essentially drop in the next three to five years.
The final standard of cell therapy may refer to the price of bone marrow transplantation.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">Another UTC co-founder, weixin.
qq.
com/s?__biz=MzAwNzMyNzQzNg==&mid=2650611245&idx=1&sn=347d6a83d0a55ea9bfe6c694eee132e1&chksm=8376658eb401ec986f9c4df09c424c7c2995b026ff5af2c672746fcd724e08cde910cfe32f2c&scene=21#wechat_redirect" textvalue="" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1" style="margin:0px;padding:0px;color:#576B95;text-decoration-line:none;-webkit-tap-highlight-color:rgba(0, 0, 0, 0);cursor:pointer;max-width:100%;box-sizing:border-box ;overflow-wrap:break-word ;">5px;color:#007AAA;text-decoration-line:underline;box-sizing:border-box ;overflow-wrap:break-word ;">Zhao Yangbing5px;"> , emphasized: "It is far from the time to consider the cost.
The first thing to consider is safety and efficacy.
The cost of cell therapy is to some extent closely related to the degree of industrialization, drug efficacy and drug quality.
It is necessary to find ways to reduce costs while ensuring the efficacy.
It cannot be said to consider the development of drugs from the cost.
Cost is indeed a problem, but with the expansion of the market, the improvement in all aspects of R&D and process, cost reduction is an inevitable trend .
This is the direction that the entire industry is working hard together.
"
Sai said that China also faces international challenges in the field of cell therapy.
The biggest problem is the lack of human resources (especially academic + industrial compound talents) and long-term development.
Investment of funds.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">"The development trend of the industry in the future depends on whether there are products on the market, whether there are new technologies introduced, and whether there are some breakthrough studies.
Ultimately, it depends on whether the above-mentioned first type of company can make money, and the second type of company can survive.
Can there be some dark horses coming out of the third category of companies.
"
75em;overflow-wrap:break-word ;">5px;">In the field of cell therapy, product pricing has always been a topic of concern and discussion.
The two CAR-T products that have been on the market worldwide, Kymriah is priced at US$475,000 per course of treatment, and Yescarta is priced at US$373,000 per course of treatment.
The high price seems to have been regarded as a label for cell therapy.
5px;">In the field of cell therapy, product pricing has always been a topic of concern and discussion.
The two CAR-T products that have been on the market worldwide, Kymriah is priced at US$475,000 per course of treatment, and Yescarta is priced at US$373,000 per course of treatment.
The high price seems to have been regarded as a label for cell therapy.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">Regarding the changing trends of future costs and pricing, it is also a topic that every company pays close attention to in this interview.
5px;">Regarding the changing trends of future costs and pricing, it is also a topic that every company pays close attention to in this interview.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">Chen Xi said that cell therapy includes two costs.
One is TCR discovery, which is research and development costs; the other is production costs.
High production costs, coupled with research and development costs, result in high final prices for such products.
However, this issue must be viewed from a developmental perspective.
The current high production cost lies in the fact that every link is not very efficient, and this part will essentially drop in the next three to five years.
The final standard of cell therapy may refer to the price of bone marrow transplantation.
5px;">Chen Xi said that cell therapy includes two costs.
One is TCR discovery, which is research and development costs; the other is production costs.
High production costs, coupled with research and development costs, result in high final prices for such products.
However, this issue must be viewed from a developmental perspective.
The current high production cost lies in the fact that every link is not very efficient, and this part will essentially drop in the next three to five years.
The final standard of cell therapy may refer to the price of bone marrow transplantation.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">Another UTC co-founder, weixin.
qq.
com/s?__biz=MzAwNzMyNzQzNg==&mid=2650611245&idx=1&sn=347d6a83d0a55ea9bfe6c694eee132e1&chksm=8376658eb401ec986f9c4df09c424c7c2995b026ff5af2c672746fcd724e08cde910cfe32f2c&scene=21#wechat_redirect" textvalue="" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1" style="margin:0px;padding:0px;color:#576B95;text-decoration-line:none;-webkit-tap-highlight-color:rgba(0, 0, 0, 0);cursor:pointer;max-width:100%;box-sizing:border-box ;overflow-wrap:break-word ;">5px;color:#007AAA;text-decoration-line:underline;box-sizing:border-box ;overflow-wrap:break-word ;">Zhao Yangbing5px;"> , emphasized: "It is far from the time to consider the cost.
The first thing to consider is safety and efficacy.
The cost of cell therapy is to some extent closely related to the degree of industrialization, drug efficacy and drug quality.
It is necessary to find ways to reduce costs while ensuring the efficacy.
It cannot be said to consider the development of drugs from the cost.
Cost is indeed a problem, but with the expansion of the market, the improvement in all aspects of R&D and process, cost reduction is an inevitable trend .
This is the direction that the entire industry is working hard together.
"5px;">UTCweixin.
qq.
com/s?__biz=MzAwNzMyNzQzNg==&mid=2650611245&idx=1&sn=347d6a83d0a55ea9bfe6c694eee132e1&chksm=8376658eb401ec986f9c4df09c424c7c2995b026ff5af2c672746fcd724e08cde910cfe32f2c&scene=21#wechat_redirect" textvalue="" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1" style="margin:0px;padding:0px;color:#576B95;text-decoration-line:none;-webkit-tap-highlight-color:rgba(0, 0, 0, 0);cursor:pointer;max-width:100%;box-sizing:border-box ;overflow-wrap:break-word ;">5px;color:#007AAA;text-decoration-line:underline;box-sizing:border-box ;overflow-wrap:break-word ;">5px;color:#007AAA;text-decoration-line:underline;box-sizing:border-box ;overflow-wrap:break-word ;">5px;">：“，。、。，，。，，，。。”
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Why do this topic?
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us" style="margin:0px;padding:0px 11px;max-width:100%;box-sizing:border-box;overflow-wrap:break-word ;color:#8A3B16;font-size:15px;letter-spacing:1px;line-height:1;font-family:Optima-Regular, PingFangTC-light;">Why do this topic?
Why do this topic?
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8;letter-spacing:1px;font-family:Optima-Regular, PingFangTC-light;">
In the field of cell therapy that has been very hot, TCR-T is one of the directions that has attracted much attention in recent years, and several well-known cell therapy companies are basically vigorously promoting the layout in this direction.
TCR refers to T cell receptor, which can guide T cells to recognize specific antigens.
Compared with CAR, TCR can recognize more target antigens, especially intracellular antigens, so it can be used in cell therapy for solid tumors that are difficult to overcome.
Play a role in the process and bring breakthroughs.
In the rapid development of TCR-T, what kind of technology and model domestic enterprises focusing on this field adopt, what challenges they face, and what policy and investment environment are the focus of this topic.
8;letter-spacing:1px;font-family:Optima-Regular, PingFangTC-light;">
In the field of cell therapy that has been very hot, TCR-T is one of the directions that has attracted much attention in recent years, and several well-known cell therapy companies are basically vigorously promoting the layout in this direction.
TCR refers to T cell receptor, which can guide T cells to recognize specific antigens.
Compared with CAR, TCR can recognize more target antigens, especially intracellular antigens, so it can be used in cell therapy for solid tumors that are difficult to overcome.
Play a role in the process and bring breakthroughs.
In the rapid development of TCR-T, what kind of technology and model domestic enterprises focusing on this field adopt, what challenges they face, and what policy and investment environment are the focus of this topic.
8;letter-spacing:1px;font-family:Optima-Regular, PingFangTC-light;">
In the field of cell therapy that has been very hot, TCR-T is one of the directions that has attracted much attention in recent years, and several well-known cell therapy companies are basically vigorously promoting the layout in this direction.
TCR refers to T cell receptor, which can guide T cells to recognize specific antigens.
Compared with CAR, TCR can recognize more target antigens, especially intracellular antigens, so it can be used in cell therapy for solid tumors that are difficult to overcome.
Play a role in the process and bring breakthroughs.
In the rapid development of TCR-T, what kind of technology and model domestic enterprises focusing on this field adopt, what challenges they face, and what policy and investment environment are the focus of this topic.
In the field of cell therapy that has been very hot, TCR-T is one of the directions that has attracted much attention in recent years, and several well-known cell therapy companies are basically vigorously promoting the layout in this direction.
TCR refers to T cell receptor, which can guide T cells to recognize specific antigens.
Compared with CAR, TCR can recognize more target antigens, especially intracellular antigens, so it can be used in cell therapy for solid tumors that are difficult to overcome.
Play a role in the process and bring breakthroughs.
In the rapid development of TCR-T, what kind of technology and model domestic enterprises focusing on this field adopt, what challenges they face, and what policy and investment environment are the focus of this topic.
TCR refers to T cell receptor, which can guide T cells to recognize specific antigens.
Compared with CAR, TCR can recognize more target antigens, especially intracellular antigens, so it can be used in cell therapy for solid tumors that are difficult to overcome.
Play a role in the process and bring breakthroughs.
In the rapid development of TCR-T, what kind of technology and model domestic enterprises focusing on this field adopt, what challenges they face, and what policy and investment environment are the focus of this topic.
What kind of technologies and models do domestic companies focusing on this field adopt, what challenges they face, policies and investment environmentus" style="margin:0px;padding:0px;max-width:100%;box-sizing:border-box;color:#333333;font-size:16px;letter-spacing:0.
544px;text-align:justify;background-color:#FFFFFF;font-family:Optima-Regular, PingFangTC-light;overflow-wrap:break-word ;">
75em;"> 5px;">In the field of cell therapy, TCR-T belongs to one of the most popular directions, representing the potential of cell therapy to extend to solid tumors.
Efficient TCR screening and development is a common challenge in this field.
At present, the global TCR-T development is in the clinical verification stage and is waiting for a breakthrough.
75em;">
75em;"> 5px;">The industry has always said that the gap between the development of Chinese cell therapy and the international advanced level is the smallest.
The Frost & Sullivan report shows that from 2021 to 2023, the scale of China's cellular immunotherapy market is expected to rise from 1.
3 billion yuan to 10.
75em;">
75em;"> 5px;">Why is cell therapy? There are many differences between cell therapy and traditional medicine, not only the difference in technology and mechanism.
Researchers interviewed some companies in this field and learned about their respective strategies and their observations and reflections on the industry, so as to understand what issues are common to China in this industry and what are the differences compared to the international ones.
Place.
75em;">
75em;"> 5px;">In the field of cell therapy, TCR-T belongs to one of the most popular directions, representing the potential of cell therapy to extend to solid tumors.
Efficient TCR screening and development is a common challenge in this field.
At present, the global TCR-T development is in the clinical verification stage and is waiting for a breakthrough.
The interpretation of this direction cannot completely escape the entire field of cell therapy.
Efficient TCR screening and development is a common challenge in this field.
At present, the global TCR-T development is in the clinical verification stage and is waiting for a breakthrough.
5px;">The industry has always said that the gap between the development of Chinese cell therapy and the international advanced level is the smallest.
5px;">Why is cell therapy? There are many differences between cell therapy and traditional medicine, not only the difference in technology and mechanism.
Researchers interviewed some companies in this field and learned about their respective strategies and their observations and reflections on the industry, so as to understand what issues are common to China in this industry and what are the differences compared to the international ones.
8px;font-family:Optima-Regular, PingFangTC-light;">
5px;">Opportunity for rapid conversion
5px;">Opportunity for rapid conversion
5px;">Opportunities for rapid conversion 5px;">Opportunities for rapid conversionus" style="margin:0px;padding:0px;max-width:100%;box-sizing:border-box;color:#333333;font-size:16px;letter-spacing:0.544px;text-align:justify;background-color:#FFFFFF;font-family:Optima-Regular, PingFangTC-light;overflow-wrap:break-word ;">
In their view, the important opportunities for the development of this industry are largely derived from clinical resources and corresponding regulatory paths.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">Chen Xi, the founder of RootPath, said that a major feature of China in the field of cell therapy is that it is more grounded and non-dogmatic.
This is largely due to the relatively loose clinical trial environment.
And the path of supervision.
"Under this regulatory framework, the scientific research and clinical aspects of cell therapy are so active, which is more beneficial for early research.
"75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">According to observations and interviews by R&D customers, many domestic cell therapy development companies will choose to conduct IIT research first, and then gradually promote the submission of INDs and enter the drug approval path.
Seeking rapid conversion is obviously an important reason why companies adopt this strategy.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">The clinical experience of Tiankeya Biotechnology has confirmed the positive role of clinical resources in rapid transformation.
According to Su Zhenbo, co-founder of Tiankeya Bio, Tiankeya has started clinical trials in both China and the United States.
As China has more abundant clinical resources, clinical trials in China only require 1/8 to 1/5 of the funds and time of the United States.
can be completed.
It is a huge advantage for the cell therapy industry that needs to continuously verify innovation with clinical trials.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">When talking about China's cell therapy industry, several interviewees unanimously mentioned its advantages of "rapid transformation" .
In their view, the important opportunities for the development of this industry are largely derived from clinical resources and corresponding regulatory paths.
5px;">When talking about China's cell therapy industry, several interviewees unanimously mentioned its advantages of "rapid transformation" .
In their view, the important opportunities for the development of this industry are largely derived from clinical resources and corresponding regulatory paths.
"Quick Conversion"75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">Chen Xi, the founder of RootPath, said that a major feature of China in the field of cell therapy is that it is more grounded and non-dogmatic.
In China, investigators can initiate clinical (IIT) rapid and small-scale verification of innovative methods and ideas, and IIT can be applied for clinical approval before the drug regulatory approval.
This part of the data can also be included in the approval by the drug regulatory agency.
Speed up the clinical process.
In the United States, the initiation of IIT must be done after the clinical approval is obtained.
Under such differences, the development of China's cell therapy products has been iteratively fast.
( 5px;">RootPath has established R&D bases in China and the United States, and will interview this company in the next issue.
5px;"> )5px;">Chen Xi, the founder of RootPath, said that a major feature of China in the field of cell therapy is that it is more grounded and non-dogmatic.
In China, investigators can initiate clinical (IIT) rapid and small-scale verification of innovative methods and ideas, and IIT can be applied for clinical approval before the drug regulatory approval.
This part of the data can also be included in the approval by the drug regulatory agency.
Speed up the clinical process.
In the United States, the initiation of IIT must be done after the clinical approval is obtained.
Under such differences, the development of China's cell therapy products has been iteratively fast.
( 5px;">RootPath has established a research and development base in China and the United States, and will interview this company in the next issue.
5px;"> RootPath has established a research and development base in China and the United States, and will interview this company in the next issue.
5px;"> RootPath has established in China and the United States The research and development base has been established, and the company will be interviewed in the next issue.
5px;">)75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">5px;">75em;overflow-wrap:break-word ;">5px;">5px;">75em;overflow-wrap:break-word ;">5px;">Song Xiaodong, the co-founder of UTC and who has many years of registered work experience, believes that China's cell therapy clinical basic research is relatively developed and can keep pace with the United States, and the number of clinical trials even exceeds that of the United States.
This is largely due to the relatively loose clinical trial environment.
And the path of supervision.
"Under this regulatory framework, the scientific research and clinical aspects of cell therapy are so active, which is more beneficial for early research.
"5px;">Song Xiaodong, the co-founder of UTC and who has many years of registered work experience, believes that China's cell therapy clinical basic research is relatively developed and can keep pace with the United States, and the number of clinical trials even exceeds that of the United States.
This is largely due to the relatively loose clinical trial environment.
And the path of supervision.
"Under this regulatory framework, the scientific research and clinical aspects of cell therapy are so active, which is more beneficial for early research.
"75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">According to observations and interviews by R&D customers, many domestic cell therapy development companies will choose to conduct IIT research first, and then gradually promote the submission of INDs and enter the drug approval path.
Seeking rapid conversion is obviously an important reason why companies adopt this strategy.
5px;">According to observations and interviews by R&D customers, many domestic cell therapy development companies will choose to conduct IIT research first, and then gradually promote the submission of INDs and enter the drug approval path.
Seeking rapid conversion is obviously an important reason why companies adopt this strategy.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">The clinical experience of Tiankeya Biotechnology has confirmed the positive role of clinical resources in rapid transformation.
According to Su Zhenbo, co-founder of Tiankeya Bio, Tiankeya has started clinical trials in both China and the United States.
As China has more abundant clinical resources, clinical trials in China only require 1/8 to 1/5 of the funds and time of the United States.
can be completed.
It is a huge advantage for the cell therapy industry that needs to continuously verify innovation with clinical trials.
5px;">The clinical experience of Tiankeya Biotechnology has confirmed the positive role of clinical resources in rapid transformation.
According to Su Zhenbo, co-founder of Tiankeya Bio, Tiankeya has started clinical trials in both China and the United States.
As China has more abundant clinical resources, clinical trials in China only require 1/8 to 1/5 of the funds and time of the United States.
can be completed.
It is a huge advantage for the cell therapy industry that needs to continuously verify innovation with clinical trials.
75em;overflow-wrap:break-word ;">544px;background-color:#FFFFFF;text-align:center;line-height:1.
75em;overflow-wrap:break-word ;'>8px;font-family:Optima-Regular, PingFangTC-light;">
5px;">Thinking of Industry Standards
8px;font-family:Optima-Regular, PingFangTC-light;">5px;">Thinking of Industry Standards
5px;">Thinking of Industry Standards
5px;">Thinking of Industry Standards 5px;">Thinking of Industry Standardsus" style="margin:0px;padding:0px;max-width:100%;box-sizing:border-box;color:#333333;font-size:16px;letter-spacing:0.544px;text-align:justify;background-color:#FFFFFF;font-family:Optima-Regular, PingFangTC-light;overflow-wrap:break-word ;">
The Health Commission treats it as a medical technology supervision, and the National Medical Products Administration (NMPA) treats it as a drug supervision.
There are differences in the perception of its attributes.
The "dual track system" has triggered the industry The most discussion and controversy.
What kind of follow-up supervision will have a considerable impact on the development of enterprises and the industry is also a topic of great concern to enterprises.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">Chen Xi said that both the US FDA and the NMPA have recently released a good signal regarding the core issue of cell therapy properties, and they tend to treat the entire process as a drug for approval.
The CAR-T products that have been marketed in the United States are approved by drugs.
In China, there are also many CAR-Ts that have obtained clinical approvals.
The entire industry has reached the more favorable side of the watershed.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">In addition to attribute identification, another very important issue under the dual-track system is standards.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">Su Zhenbo told R&D customers that compared with new medical technology, drug supervision will have higher requirements and better standardization, and if the cell therapy industry wants to develop well, it must be more standardized and follow a more standardized approach to the end.
In fact, it will bring faster development speed.
"From our point of view, what the industry needs to improve most is that it needs to be more standardized to do this.
Strictly follow drug development, so that the entire industry can be made bigger.
"
5px;">
75em;text-align:right;overflow-wrap:break-word ;">5px;">Tiankeya's development history Source|Tiankeya official website
5px;">
.
He also raised a realistic question.
If clinical research on cell therapy is carried out under the framework of the National Health Commission, companies should consider as far as possible to carry out production and quality control in accordance with the quality requirements of the Phase I clinical or close to the Phase I clinical of the Food and Drug Administration.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">At some previous meetings, the Food and Drug Administration was also delivering such information that the data obtained by non-registered clinics must also meet the relevant requirements of the CDE before it may be used in the subsequent IND process.
The Food and Drug Administration has stricter quality control requirements for many of these details, and clearly requires that you follow the ideas of drug development, not scientific research.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">Mr.
Sai, a senior investor who has invested in many cell therapy companies and is very concerned about the field, said that because there are no good animal models or other non-clinical verification methods in this field, human research is a very important point for verifying innovation.
Therefore, they will introduce many invested companies to China, hoping to quickly carry out human research.
But in the process, he also found that supervision is now gradually tightening, and the supervisory department has become more prudent.
Under this trend, companies that are more detailed, more capable, and more resource-rich may have an advantage.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">However, the clinical path brings opportunities and risks.
The Health Commission treats it as a medical technology supervision, and the National Medical Products Administration (NMPA) treats it as a drug supervision.
There are differences in the perception of its attributes.
The "dual track system" has triggered the industry The most discussion and controversy.
What kind of follow-up supervision will have a considerable impact on the development of enterprises and the industry is also a topic of great concern to enterprises.
5px;">However, the clinical path brings opportunities and risks.
The Health Commission treats it as a medical technology supervision, and the National Medical Products Administration (NMPA) treats it as a drug supervision.
There are differences in the perception of its attributes.
The "dual track system" has triggered the industry The most discussion and controversy.
What kind of follow-up supervision will have a considerable impact on the development of enterprises and the industry is also a topic of great concern to enterprises.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">Chen Xi said that both the US FDA and the NMPA have recently released a good signal regarding the core issue of cell therapy properties, and they tend to treat the entire process as a drug for approval.
The CAR-T products that have been marketed in the United States are approved by drugs.
In China, there are also many CAR-Ts that have obtained clinical approvals.
The entire industry has reached the more favorable side of the watershed.
5px;">Chen Xi said that both the US FDA and the NMPA have recently released a good signal regarding the core issue of cell therapy properties, and they tend to treat the entire process as a drug for approval.
The CAR-T products that have been marketed in the United States are approved by drugs.
In China, there are also many CAR-Ts that have obtained clinical approvals.
The entire industry has reached the more favorable side of the watershed.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">In addition to attribute identification, another very important issue under the dual-track system is standards.
5px;">In addition to attribute identification, another very important issue under the dual-track system is standards.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">Su Zhenbo told R&D customers that compared with new medical technology, drug supervision will have higher requirements and better standardization, and if the cell therapy industry wants to develop well, it must be more standardized and follow a more standardized approach to the end.
In fact, it will bring faster development speed.
"From our point of view, what the industry needs to improve most is that it needs to be more standardized to do this.
Strictly follow drug development, so that the entire industry can be made bigger.
"5px;">Su Zhenbo told R&D customers that compared with new medical technology, drug supervision will have higher requirements and better standardization, and if the cell therapy industry wants to develop well, it must be more standardized and follow a more standardized approach to the end.
In fact, it will bring faster development speed.
"From our point of view, what the industry needs to improve most is that it needs to be more standardized to do this.
Strictly follow drug development, so that the entire industry can be made bigger.
"
5px;">
75em;text-align:right;overflow-wrap:break-word ;">5px;">Tiankeya's development history Source|Tiankeya official website5px;">The development history of Tiankeya Source|The official website of Tiankeya The development history of Tiankeya Source|The development history of Tiankeya's official website Source|The official website of Tiankeya
5px;">
.
He also raised a realistic question.
If clinical research on cell therapy is carried out under the framework of the National Health Commission, companies should consider as far as possible to carry out production and quality control in accordance with the quality requirements of the Phase I clinical or close to the Phase I clinical of the Food and Drug Administration.
5px;">Song Xiaodong believes that once cell therapy products are applied to the clinic or to patients, no matter what path is taken, they should follow the same standard, comply with the recently promulgated drug management measures, and follow the most rigorous standards and strict accountability.
.
He also raised a realistic question.
If clinical research on cell therapy is carried out under the framework of the National Health Commission, companies should consider as far as possible to carry out production and quality control in accordance with the quality requirements of the Phase I clinical or close to the Phase I clinical of the Food and Drug Administration.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">At some previous meetings, the Food and Drug Administration was also delivering such information that the data obtained by non-registered clinics must also meet the relevant requirements of the CDE before it may be used in the subsequent IND process.
The Food and Drug Administration has stricter quality control requirements for many of these details, and clearly requires that you follow the ideas of drug development, not scientific research.
5px;">At some previous meetings, the Food and Drug Administration was also delivering such information that the data obtained by non-registered clinics must also meet the relevant requirements of the CDE before it may be used in the subsequent IND process.
The Food and Drug Administration has stricter quality control requirements for many of these details, and clearly requires that you follow the ideas of drug development, not scientific research.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">Mr.
Sai, a senior investor who has invested in many cell therapy companies and is very concerned about the field, said that because there are no good animal models or other non-clinical verification methods in this field, human research is a very important point for verifying innovation.
Therefore, they will introduce many invested companies to China, hoping to quickly carry out human research.
But in the process, he also found that supervision is now gradually tightening, and the supervisory department has become more prudent.
Under this trend, companies that are more detailed, more capable, and more resource-rich may have an advantage.
5px;">Mr.
Sai, a senior investor who has invested in many cell therapy companies and is very concerned about the field, said that because there are no good animal models or other non-clinical verification methods in this field, human research is a very important point for verifying innovation.
Therefore, they will introduce many invested companies to China, hoping to quickly carry out human research.
But in the process, he also found that supervision is now gradually tightening, and the supervisory department has become more prudent.
Under this trend, companies that are more detailed, more capable, and more resource-rich may have an advantage.
75em;overflow-wrap:break-word ;">544px;background-color:#FFFFFF;text-align:center;line-height:1.
75em;overflow-wrap:break-word ;'>8px;font-family:Optima-Regular, PingFangTC-light;">
5px;">The layout of the two places is becoming a trend
8px;font-family:Optima-Regular, PingFangTC-light;">5px;">The layout of the two places is becoming a trend
5px;">The layout of the two places is becoming a trend
5px;">The layout of the two places has gradually become a trend The layout of the two places has become a trendus" style="margin:0px;padding:0px;max-width:100%;box-sizing:border-box;color:#333333;font-size:16px;letter-spacing:0.544px;text-align:justify;background-color:#FFFFFF;font-family:Optima-Regular, PingFangTC-light;overflow-wrap:break-word ;">
Sai’s observation, in China, cell therapy development companies are mainly divided into three categories: The first type of company is usually authorized by foreign countries to bring technology from the world.
This type of company has a certain reputation and has some progress; the second type The company also has some breakthroughs, mainly micro-innovation and micro-change; the third type of company may have some good technologies, but their innovation and team lack the ability to continue to do well, or to promote the product to the international level.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">Among them, companies with the ability to go overseas are the most valued by investors, and they are also an important consideration for his investment in cell therapy companies.
He explained that the greatest potential of cell therapy in the future lies in overseas markets, because overseas markets are large and medical insurance strategies are more suitable for cell therapy products.
The ability to go to overseas markets mainly measures whether the technology has the obvious advantages of global advancement, sufficient innovation and differentiation.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">In fact, most of the companies interviewed this time have initiated overseas deployments, including applying for clinical trials and setting up R&D centers in the United States, and most of their founding teams also have relevant work experience in the field of overseas cell therapy.
It can be said that taking China as the base point for rapid transformation and going international is an important strategy and trend.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">However, Su Zhenbo said that this strategy also has difficulties.
The clinical development in China and the United States will inevitably involve production problems.
Currently, cell drug production in the United States is still a pain point.
Many companies do not have production capacity in the United States and need to rely on CDMO.
When it comes to process issues, you need to wait in line, sometimes even two years.
Therefore, there are really not many companies capable of simultaneously conducting drug development, CMC and production, and clinical trials on both sides.
The consideration of speed is also one of the reasons why Tiankeya finally established a GMP production base in the United States.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">According to Mr.
Sai’s observation, in China, cell therapy development companies are mainly divided into three categories: The first type of company is usually authorized by foreign countries to bring technology from the world.
This type of company has a certain reputation and has some progress; the second type The company also has some breakthroughs, mainly micro-innovation and micro-change; the third type of company may have some good technologies, but their innovation and team lack the ability to continue to do well, or to promote the product to the international level.
5px;">According to Mr.
Sai’s observation, in China, cell therapy development companies are mainly divided into three categories: The first type of company is usually authorized by foreign countries to bring technology from the world.
This type of company has a certain reputation and has some progress; the second type The company also has some breakthroughs, mainly micro-innovation and micro-change; the third type of company may have some good technologies, but their innovation and team lack the ability to continue to do well, or to promote the product to the international level.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">Among them, companies with the ability to go overseas are the most valued by investors, and they are also an important consideration for his investment in cell therapy companies.
He explained that the greatest potential of cell therapy in the future lies in overseas markets, because overseas markets are large and medical insurance strategies are more suitable for cell therapy products.
The ability to go to overseas markets mainly measures whether the technology has the obvious advantages of global advancement, sufficient innovation and differentiation.
5px;">Among them, companies with the ability to go overseas are the most valued by investors, and they are also an important consideration for his investment in cell therapy companies.
He explained that the greatest potential of cell therapy in the future lies in overseas markets, because overseas markets are large and medical insurance strategies are more suitable for cell therapy products.
The ability to go to overseas markets mainly measures whether the technology has the obvious advantages of global advancement, sufficient innovation and differentiation.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">In fact, most of the companies interviewed this time have initiated overseas deployments, including applying for clinical trials and setting up R&D centers in the United States, and most of their founding teams also have relevant work experience in the field of overseas cell therapy.
It can be said that taking China as the base point for rapid transformation and going international is an important strategy and trend.
5px;">In fact, most of the companies interviewed this time have initiated overseas deployments, including applying for clinical trials and setting up R&D centers in the United States, and most of their founding teams also have relevant work experience in the field of overseas cell therapy.
It can be said that taking China as the base point for rapid transformation and going international is an important strategy and trend.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">However, Su Zhenbo said that this strategy also has difficulties.
The clinical development in China and the United States will inevitably involve production problems.
Currently, cell drug production in the United States is still a pain point.
Many companies do not have production capacity in the United States and need to rely on CDMO.
When it comes to process issues, you need to wait in line, sometimes even two years.
Therefore, there are really not many companies capable of simultaneously conducting drug development, CMC and production, and clinical trials on both sides.
The consideration of speed is also one of the reasons why Tiankeya finally established a GMP production base in the United States.
5px;">However, Su Zhenbo said that this strategy also has difficulties.
The clinical development in China and the United States will inevitably involve production problems.
Currently, cell drug production in the United States is still a pain point.
Many companies do not have production capacity in the United States and need to rely on CDMO.
When it comes to process issues, you need to wait in line, sometimes even two years.
Therefore, there are really not many companies capable of simultaneously conducting drug development, CMC and production, and clinical trials on both sides.
The consideration of speed is also one of the reasons why Tiankeya finally established a GMP production base in the United States.
75em;overflow-wrap:break-word ;">544px;background-color:#FFFFFF;text-align:center;line-height:1.
75em;overflow-wrap:break-word ;'>8px;font-family:Optima-Regular, PingFangTC-light;">
5px;">On the way to reduce costs
8px;font-family:Optima-Regular, PingFangTC-light;">5px;">On the way to reduce costs
5px;">On the way to reduce costs
5px;">On the way to reduce costs, on 5px;">the way to reduce costsus" style="margin:0px;padding:0px;max-width:100%;box-sizing:border-box;color:#333333;font-size:16px;letter-spacing:0.544px;text-align:justify;background-color:#FFFFFF;font-family:Optima-Regular, PingFangTC-light;overflow-wrap:break-word ;">
The two CAR-T products that have been on the market worldwide, Kymriah is priced at US$475,000 per course of treatment, and Yescarta is priced at US$373,000 per course of treatment.
The high price seems to have been regarded as a label for cell therapy.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">Regarding the changing trends of future costs and pricing, it is also a topic that every company pays close attention to in this interview.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">Chen Xi said that cell therapy includes two costs.
One is TCR discovery, which is research and development costs; the other is production costs.
High production costs, coupled with research and development costs, result in high final prices for such products.
However, this issue must be viewed from a developmental perspective.
The current high production cost lies in the fact that every link is not very efficient, and this part will essentially drop in the next three to five years.
The final standard of cell therapy may refer to the price of bone marrow transplantation.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">Another UTC co-founder, weixin.
qq.
com/s?__biz=MzAwNzMyNzQzNg==&mid=2650611245&idx=1&sn=347d6a83d0a55ea9bfe6c694eee132e1&chksm=8376658eb401ec986f9c4df09c424c7c2995b026ff5af2c672746fcd724e08cde910cfe32f2c&scene=21#wechat_redirect" textvalue="" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1" style="margin:0px;padding:0px;color:#576B95;text-decoration-line:none;-webkit-tap-highlight-color:rgba(0, 0, 0, 0);cursor:pointer;max-width:100%;box-sizing:border-box ;overflow-wrap:break-word ;">5px;color:#007AAA;text-decoration-line:underline;box-sizing:border-box ;overflow-wrap:break-word ;">Zhao Yangbing5px;"> , emphasized: "It is far from the time to consider the cost.
The first thing to consider is safety and efficacy.
The cost of cell therapy is to some extent closely related to the degree of industrialization, drug efficacy and drug quality.
It is necessary to find ways to reduce costs while ensuring the efficacy.
It cannot be said to consider the development of drugs from the cost.
Cost is indeed a problem, but with the expansion of the market, the improvement in all aspects of R&D and process, cost reduction is an inevitable trend .
This is the direction that the entire industry is working hard together.
"
75em;overflow-wrap:break-word ;">5px;">Finally, when talking about the judgment of the overall development of the industry, Mr.
Sai said that China also faces international challenges in the field of cell therapy.
The biggest problem is the lack of human resources (especially academic + industrial compound talents) and long-term development.
Investment of funds.
75em;overflow-wrap:break-word ;">
75em;overflow-wrap:break-word ;">5px;">"The development trend of the industry in the future depends on whether there are products on the market, whether there are new technologies introduced, and whether there are some breakthrough studies.
Ultimately, it depends on whether the above-mentioned first type of company can make money, and the second type of company can survive.
Can there be some dark horses coming out of the third category of companies.
"
75em;overflow-wrap:break-word ;">5px;">In the field of cell therapy, product pricing has always been a topic of concern and discussion.
The two CAR-T products that have been on the market worldwide, Kymriah is priced at US$475,000 per course of treatment, and Yescarta is priced at US$373,000 per course of treatment.
The high price seems to have been regarded as a label for cell therapy.
5px;">In the field of cell therapy, product pricing has always been a topic of concern and discussion.
The two CAR-T products that have been on the market worldwide, Kymriah is priced at US$475,000 per course of treatment, and Yescarta is priced at US$373,000 per course of treatment.
The high price seems to have been regarded as a label for cell therapy.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">Regarding the changing trends of future costs and pricing, it is also a topic that every company pays close attention to in this interview.
5px;">Regarding the changing trends of future costs and pricing, it is also a topic that every company pays close attention to in this interview.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">Chen Xi said that cell therapy includes two costs.
One is TCR discovery, which is research and development costs; the other is production costs.
High production costs, coupled with research and development costs, result in high final prices for such products.
However, this issue must be viewed from a developmental perspective.
The current high production cost lies in the fact that every link is not very efficient, and this part will essentially drop in the next three to five years.
The final standard of cell therapy may refer to the price of bone marrow transplantation.
5px;">Chen Xi said that cell therapy includes two costs.
One is TCR discovery, which is research and development costs; the other is production costs.
High production costs, coupled with research and development costs, result in high final prices for such products.
However, this issue must be viewed from a developmental perspective.
The current high production cost lies in the fact that every link is not very efficient, and this part will essentially drop in the next three to five years.
The final standard of cell therapy may refer to the price of bone marrow transplantation.
75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">Another UTC co-founder, weixin.
qq.
com/s?__biz=MzAwNzMyNzQzNg==&mid=2650611245&idx=1&sn=347d6a83d0a55ea9bfe6c694eee132e1&chksm=8376658eb401ec986f9c4df09c424c7c2995b026ff5af2c672746fcd724e08cde910cfe32f2c&scene=21#wechat_redirect" textvalue="" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1" style="margin:0px;padding:0px;color:#576B95;text-decoration-line:none;-webkit-tap-highlight-color:rgba(0, 0, 0, 0);cursor:pointer;max-width:100%;box-sizing:border-box ;overflow-wrap:break-word ;">5px;color:#007AAA;text-decoration-line:underline;box-sizing:border-box ;overflow-wrap:break-word ;">Zhao Yangbing5px;"> , emphasized: "It is far from the time to consider the cost.
The first thing to consider is safety and efficacy.
The cost of cell therapy is to some extent closely related to the degree of industrialization, drug efficacy and drug quality.
It is necessary to find ways to reduce costs while ensuring the efficacy.
It cannot be said to consider the development of drugs from the cost.
Cost is indeed a problem, but with the expansion of the market, the improvement in all aspects of R&D and process, cost reduction is an inevitable trend .
This is the direction that the entire industry is working hard together.
"5px;">UTCweixin.
qq.
com/s?__biz=MzAwNzMyNzQzNg==&mid=2650611245&idx=1&sn=347d6a83d0a55ea9bfe6c694eee132e1&chksm=8376658eb401ec986f9c4df09c424c7c2995b026ff5af2c672746fcd724e08cde910cfe32f2c&scene=21#wechat_redirect" textvalue="" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1" style="margin:0px;padding:0px;color:#576B95;text-decoration-line:none;-webkit-tap-highlight-color:rgba(0, 0, 0, 0);cursor:pointer;max-width:100%;box-sizing:border-box ;overflow-wrap:break-word ;">5px;color:#007AAA;text-decoration-line:underline;box-sizing:border-box ;overflow-wrap:break-word ;">5px;color:#007AAA;text-decoration-line:underline;box-sizing:border-box ;overflow-wrap:break-word ;">5px;">：“，。、。，，。，，，。。”
75em;overflow-wrap:break-word ;">5px;">，，，，（+）。5px;">，，，，（+）。75em;overflow-wrap:break-word ;">75em;overflow-wrap:break-word ;">5px;">“、。，，。”5px;">“、。，，。”
