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[Pharmaceutical Network Market Analysis] Recently, the news that the high-profile domestic PD-1 sintilimab has lost ODAC has attracted widespread attention in the pharmaceutical industry
.
For pharmaceutical companies eager to go overseas to open up new markets, will overseas markets become more and more difficult in the future? How can local new drugs go overseas smoothly? In response to these issues, the industry has also carried out heated discussions
.
Judging from the achievements of local new drugs in the process of going overseas, there are currently 5 local innovative drugs that have been successfully approved abroad, including the prescription drug Kanglaite injection for the treatment of cancer, BeiGene's zanubrutinib, and Frontier Bio's Aibo Weitai, Chidamide from Microchip Bio, and Prokalutamide from Kintor Pharmaceuticals,
etc.
In addition, there are a large number of local pharmaceutical companies actively deploying overseas new drug markets, including Hengrui Pharmaceuticals, Fosun Pharmaceuticals, and CStone Pharmaceuticals
.
Among them, Hengrui Medicine and BeiGene have in-depth overseas layouts.
Hengrui Medicine has already deployed 22 new drugs overseas, and there are many products that will enter the harvest period from Phase III clinical trials
.
BeiGene followed with 15 layouts
.
On February 19, BeiGene announced that its zanubrutinib has been approved by the Swiss Food and Drug Administration for the treatment of Waldenström macroglobulinemia (WM) in adults who have received at least one prior therapy, or as a chemotherapeutic Immunotherapy for first-line treatment of patients with WM
.
The product has been approved for the first time in the world in the United States in November 2019, and has become a new domestic anti-cancer drug that has been successfully sold overseas.
It has subsequently been approved for listing in China, Canada, Australia, Russia, the European Union and other countries and regions.
Currently, its commercial The chemical footprint has spread to 44 markets around the world
.
In addition, there are still more than 40 drug regulatory filings under review globally
.
Judging from the above-mentioned achievements, it is undeniable that the innovation strength of domestic pharmaceutical companies is improving.
They no longer rely on foreign-funded companies to "input" R&D as before.
Some companies have already qualified for going overseas and accumulated certain experience.
.
The industry pointed out that the "frustration" of domestic PD-1 this time may not be a problem of the drug itself, but may be related to factors such as review materials, the surge in the number of PD-1, and the adjustment of regulatory requirements.
In 2021, the FDA has already seen a wave of concentrated withdrawals.
, especially in the field of PD-1/PD-L1 antibodies
.
However, this experience can also be regarded as the direction of FDA policy and new rules in the future.
Local pharmaceutical companies need to be prepared to communicate with overseas regulatory agencies, and timely and actively adjust their clinical research strategies according to changes in the clinical landscape.
.
"However, although domestic new drugs have encountered setbacks temporarily, under the normalization of domestic centralized procurement, the pressure of medical insurance price reduction, and the homogenization of competition, innovative drugs are unstoppable
.
" In the view of some medical professionals, local pharmaceutical companies are in the process of establishing projects.
At the same time, the project must be reported in both China and the United States; in addition, the key point is that the same project must be able to break through in order to realize the possibility of License out
.
Previously, the relevant person in charge of Hengrui Medicine once said that the international layout needs to overcome the cultural, legal and institutional problems of "acclimatization", because overseas research and development, production and commercialization will involve a series of complex issues, including the formation of localization.
The R&D team, strengthening cooperation with local regulatory agencies, medical and scientific research institutions, etc.
, will face greater challenges if they are not familiar enough
.
Recently, BeiGene mentioned in an interview with the media that the layout of products going overseas should be considered in the overall R&D strategy.
At the same time, the pattern of market competition should also be carefully considered to evaluate whether a product is suitable for internationalization.
.
In general, under the premise of ensuring that the products meet the requirements of going overseas, local new drugs need to understand the requirements of overseas supervision and communicate in a timely manner.
At the same time, they also need to prepare for foreign R&D, production and commercialization in the future
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
For pharmaceutical companies eager to go overseas to open up new markets, will overseas markets become more and more difficult in the future? How can local new drugs go overseas smoothly? In response to these issues, the industry has also carried out heated discussions
.
Judging from the achievements of local new drugs in the process of going overseas, there are currently 5 local innovative drugs that have been successfully approved abroad, including the prescription drug Kanglaite injection for the treatment of cancer, BeiGene's zanubrutinib, and Frontier Bio's Aibo Weitai, Chidamide from Microchip Bio, and Prokalutamide from Kintor Pharmaceuticals,
etc.
In addition, there are a large number of local pharmaceutical companies actively deploying overseas new drug markets, including Hengrui Pharmaceuticals, Fosun Pharmaceuticals, and CStone Pharmaceuticals
.
Among them, Hengrui Medicine and BeiGene have in-depth overseas layouts.
Hengrui Medicine has already deployed 22 new drugs overseas, and there are many products that will enter the harvest period from Phase III clinical trials
.
BeiGene followed with 15 layouts
.
On February 19, BeiGene announced that its zanubrutinib has been approved by the Swiss Food and Drug Administration for the treatment of Waldenström macroglobulinemia (WM) in adults who have received at least one prior therapy, or as a chemotherapeutic Immunotherapy for first-line treatment of patients with WM
.
The product has been approved for the first time in the world in the United States in November 2019, and has become a new domestic anti-cancer drug that has been successfully sold overseas.
It has subsequently been approved for listing in China, Canada, Australia, Russia, the European Union and other countries and regions.
Currently, its commercial The chemical footprint has spread to 44 markets around the world
.
In addition, there are still more than 40 drug regulatory filings under review globally
.
Judging from the above-mentioned achievements, it is undeniable that the innovation strength of domestic pharmaceutical companies is improving.
They no longer rely on foreign-funded companies to "input" R&D as before.
Some companies have already qualified for going overseas and accumulated certain experience.
.
The industry pointed out that the "frustration" of domestic PD-1 this time may not be a problem of the drug itself, but may be related to factors such as review materials, the surge in the number of PD-1, and the adjustment of regulatory requirements.
In 2021, the FDA has already seen a wave of concentrated withdrawals.
, especially in the field of PD-1/PD-L1 antibodies
.
However, this experience can also be regarded as the direction of FDA policy and new rules in the future.
Local pharmaceutical companies need to be prepared to communicate with overseas regulatory agencies, and timely and actively adjust their clinical research strategies according to changes in the clinical landscape.
.
"However, although domestic new drugs have encountered setbacks temporarily, under the normalization of domestic centralized procurement, the pressure of medical insurance price reduction, and the homogenization of competition, innovative drugs are unstoppable
.
" In the view of some medical professionals, local pharmaceutical companies are in the process of establishing projects.
At the same time, the project must be reported in both China and the United States; in addition, the key point is that the same project must be able to break through in order to realize the possibility of License out
.
Previously, the relevant person in charge of Hengrui Medicine once said that the international layout needs to overcome the cultural, legal and institutional problems of "acclimatization", because overseas research and development, production and commercialization will involve a series of complex issues, including the formation of localization.
The R&D team, strengthening cooperation with local regulatory agencies, medical and scientific research institutions, etc.
, will face greater challenges if they are not familiar enough
.
Recently, BeiGene mentioned in an interview with the media that the layout of products going overseas should be considered in the overall R&D strategy.
At the same time, the pattern of market competition should also be carefully considered to evaluate whether a product is suitable for internationalization.
.
In general, under the premise of ensuring that the products meet the requirements of going overseas, local new drugs need to understand the requirements of overseas supervision and communicate in a timely manner.
At the same time, they also need to prepare for foreign R&D, production and commercialization in the future
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
