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This month, “Legend Bio” obtained the US FDA (Food and Drug Administration) marketing approval for its self-developed CAR-T product, Sidaki Orenza, injecting a shot of cardiotonic into the domestic innovative drug track
.
Investors from Duoyao said that the approval of Legend Bio's CAR-T products by the FDA is another huge breakthrough for domestic innovative drugs, which greatly enhances the confidence of the industry
.
According to the industry, the "going overseas" of innovative drugs is becoming a crucial breakthrough point for the development of domestic innovative drugs
.
In addition, some analysts also pointed out that the "going out" of domestic innovative drugs is not only the time, but also the future
.
From a policy perspective, the "14th Five-Year Plan for the Development of the Pharmaceutical Industry" (referred to as the "Plan") jointly issued by the nine departments this year clearly lists the overall acceleration of international development as one of six specific goals
.
The "Planning" pointed out that it is necessary to cultivate a group of world-renowned brands; to form a group of large pharmaceutical companies with globalized R&D and production layout and a high proportion of international sales
.
Actively respond to the new situation of the global pharmaceutical innovation chain, industrial chain, and supply chain reshaping, deepen industrial international cooperation, accelerate the cultivation of new competitive advantages, and integrate into the global innovation network and industrial system at a higher level
.
It is time for innovative drugs to go overseas, and those pharmaceutical companies that adhere to clinical value and truly have innovative strength may go further
.
For example, through continuous technological innovation, Legend Bio has made important breakthroughs in product research and development.
As the core product CARVYKTI (Cidaki Orenza), it is expected to solve the problem of multiple myeloma treatment after landing in the US market
.
This is also an important process in the company's development process, and it is also a sign that the company has entered a new stage of commercial development
.
In addition to Legend Bio, this month Tianjing Bio's bispecific antibody TJ-CD4B was also granted orphan drug designation by the FDA for the treatment of gastric cancer (including gastroesophageal junction cancer), becoming an approved clinical and FDA orphan drug Qualified Claudin 18.
2/4-1BB bispecific antibody
.
And these cases also prove that Chinese innovative drugs with real clinical value are still promising; pharmaceutical companies can only go through rigorous audits and go to the world if they have real materials.
.
Some insiders said that the correct posture for China's innovative drugs to go overseas is to make good use of their own advantages down-to-earth, and then have the opportunity to compete with the strong
.
"Starting from the basics, accumulating your own R&D system step by step, respecting the market, and respecting the rules, can the market respect domestic innovators
.
" In addition, some analysts believe that from the current point of view, the overseas development of innovative drugs is not only a matter of Challenges are also opportunities
.
The person pointed out that there is a clearer path for the listing and application of innovative drugs in the United States
.
As for how to break through the situation, from the perspective of the transformation of innovative drugs, enterprises also need to make differentiated layouts according to their own stages and advantages
.
It is understood that in recent years, domestic innovative drugs have not been able to go overseas.
The approval of the legendary bio-Xidaki Orenza has injected a booster for domestic innovative drug research and development enterprises, and is also an important event for the internationalization of domestic innovative drugs
.
Analysts said that due to the influence of domestic and foreign market factors, industrial policy factors and other factors, the pattern of domestic innovative drugs going overseas has been continuously optimized, and the policy is moving towards long-term encouragement of innovative development.
The value range is a better time for strategically deploying innovative drugs
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
Investors from Duoyao said that the approval of Legend Bio's CAR-T products by the FDA is another huge breakthrough for domestic innovative drugs, which greatly enhances the confidence of the industry
.
According to the industry, the "going overseas" of innovative drugs is becoming a crucial breakthrough point for the development of domestic innovative drugs
.
In addition, some analysts also pointed out that the "going out" of domestic innovative drugs is not only the time, but also the future
.
From a policy perspective, the "14th Five-Year Plan for the Development of the Pharmaceutical Industry" (referred to as the "Plan") jointly issued by the nine departments this year clearly lists the overall acceleration of international development as one of six specific goals
.
The "Planning" pointed out that it is necessary to cultivate a group of world-renowned brands; to form a group of large pharmaceutical companies with globalized R&D and production layout and a high proportion of international sales
.
Actively respond to the new situation of the global pharmaceutical innovation chain, industrial chain, and supply chain reshaping, deepen industrial international cooperation, accelerate the cultivation of new competitive advantages, and integrate into the global innovation network and industrial system at a higher level
.
It is time for innovative drugs to go overseas, and those pharmaceutical companies that adhere to clinical value and truly have innovative strength may go further
.
For example, through continuous technological innovation, Legend Bio has made important breakthroughs in product research and development.
As the core product CARVYKTI (Cidaki Orenza), it is expected to solve the problem of multiple myeloma treatment after landing in the US market
.
This is also an important process in the company's development process, and it is also a sign that the company has entered a new stage of commercial development
.
In addition to Legend Bio, this month Tianjing Bio's bispecific antibody TJ-CD4B was also granted orphan drug designation by the FDA for the treatment of gastric cancer (including gastroesophageal junction cancer), becoming an approved clinical and FDA orphan drug Qualified Claudin 18.
2/4-1BB bispecific antibody
.
And these cases also prove that Chinese innovative drugs with real clinical value are still promising; pharmaceutical companies can only go through rigorous audits and go to the world if they have real materials.
.
Some insiders said that the correct posture for China's innovative drugs to go overseas is to make good use of their own advantages down-to-earth, and then have the opportunity to compete with the strong
.
"Starting from the basics, accumulating your own R&D system step by step, respecting the market, and respecting the rules, can the market respect domestic innovators
.
" In addition, some analysts believe that from the current point of view, the overseas development of innovative drugs is not only a matter of Challenges are also opportunities
.
The person pointed out that there is a clearer path for the listing and application of innovative drugs in the United States
.
As for how to break through the situation, from the perspective of the transformation of innovative drugs, enterprises also need to make differentiated layouts according to their own stages and advantages
.
It is understood that in recent years, domestic innovative drugs have not been able to go overseas.
The approval of the legendary bio-Xidaki Orenza has injected a booster for domestic innovative drug research and development enterprises, and is also an important event for the internationalization of domestic innovative drugs
.
Analysts said that due to the influence of domestic and foreign market factors, industrial policy factors and other factors, the pattern of domestic innovative drugs going overseas has been continuously optimized, and the policy is moving towards long-term encouragement of innovative development.
The value range is a better time for strategically deploying innovative drugs
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.