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[Pharmaceutical Network Market Analysis] In recent years, with the continuous increase of local pharmaceutical companies' investment in new drug research and development, and the continuous improvement of their strength, China and the United States have reported that the number of Chinese pharmaceutical companies listed in Europe and the United States is increasing year by year.
At the same time, a large number of domestic new drugs Also began to speed up the sea
.
Recently, Humanwell Pharmaceutical announced that its holding subsidiary Humanwell Pharmaceutical US, Inc.
received the tentative approval number for tapentadol from the US FDA
.
Tapentadol tablets are used for the treatment of acute pain.
Yichang Renfu Pharmaceutical US Company submitted an ANDA application for Tapentadol tablets in 2020.
The cumulative investment in research and development of the project is about RMB 15 million
.
In addition to Renfu Medicine, since the beginning of this year, there has been a continuous flow of good news about domestic new drugs going overseas
.
For example, on February 28, Legend Bio announced that its self-developed cell therapy product, Cidaki Aurexa (trade name CARVYKTI), was approved by the U.
S.
Food and Drug Administration (FDA), and it was also the first cell therapy approved by the FDA in China.
product
.
The approval is for the treatment of patients with relapsed or refractory multiple myeloma (R/R MM) who have received four or more prior therapies, including proteasome inhibitors, immunomodulators and Anti-CD38 monoclonal antibody,
etc.
On February 19, BeiGene announced that its zanubrutinib has been approved by the Swiss Food and Drug Administration for the treatment of adults with Waldenström macroglobulinemia (WM) 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 applications under review worldwide
.
Judging from the above, the innovation strength of domestic pharmaceutical companies is constantly improving, and they no longer rely on foreign companies to "input" R&D as before.
Some companies have already qualified for going overseas and accumulated certain experience
.
The industry predicts that in the future, more and more domestic pharmaceutical companies will accelerate the promotion of products through FDA and other certifications in order to expand the market scope and better avoid the impact of medical insurance cost control
.
However, it should be noted that in the context of the acceleration of domestic innovative drugs to go overseas, there have also been some twists and turns of related companies going overseas
.
It is reported that following the failure of Cinda Bio to go overseas, Junshi Bio and Chi-Med also suffered setbacks in going overseas on May 2
.
The FDA said that the PD-1 for nasopharyngeal cancer jointly developed by Junshi Bio and its partner Coherus was unable to conduct on-site inspections at the facility due to travel restrictions during the epidemic.
Submit an application for drug approval
.
And Chi-Med is because the current data package based on two successful phase III studies in China and a bridging study in the United States is not enough to support the current approval of the drug in the United States
.
Analysts believe that the above cases do not mean that overseas markets have closed the door to domestic innovative drugs
.
The industry believes that this is a reminder that Chinese innovative pharmaceutical companies should focus on the design of clinical trials and the selection of clinical endpoints when listing overseas to cope with the current changing clinical landscape
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
At the same time, a large number of domestic new drugs Also began to speed up the sea
.
Recently, Humanwell Pharmaceutical announced that its holding subsidiary Humanwell Pharmaceutical US, Inc.
received the tentative approval number for tapentadol from the US FDA
.
Tapentadol tablets are used for the treatment of acute pain.
Yichang Renfu Pharmaceutical US Company submitted an ANDA application for Tapentadol tablets in 2020.
The cumulative investment in research and development of the project is about RMB 15 million
.
In addition to Renfu Medicine, since the beginning of this year, there has been a continuous flow of good news about domestic new drugs going overseas
.
For example, on February 28, Legend Bio announced that its self-developed cell therapy product, Cidaki Aurexa (trade name CARVYKTI), was approved by the U.
S.
Food and Drug Administration (FDA), and it was also the first cell therapy approved by the FDA in China.
product
.
The approval is for the treatment of patients with relapsed or refractory multiple myeloma (R/R MM) who have received four or more prior therapies, including proteasome inhibitors, immunomodulators and Anti-CD38 monoclonal antibody,
etc.
On February 19, BeiGene announced that its zanubrutinib has been approved by the Swiss Food and Drug Administration for the treatment of adults with Waldenström macroglobulinemia (WM) 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 applications under review worldwide
.
Judging from the above, the innovation strength of domestic pharmaceutical companies is constantly improving, and they no longer rely on foreign companies to "input" R&D as before.
Some companies have already qualified for going overseas and accumulated certain experience
.
The industry predicts that in the future, more and more domestic pharmaceutical companies will accelerate the promotion of products through FDA and other certifications in order to expand the market scope and better avoid the impact of medical insurance cost control
.
However, it should be noted that in the context of the acceleration of domestic innovative drugs to go overseas, there have also been some twists and turns of related companies going overseas
.
It is reported that following the failure of Cinda Bio to go overseas, Junshi Bio and Chi-Med also suffered setbacks in going overseas on May 2
.
The FDA said that the PD-1 for nasopharyngeal cancer jointly developed by Junshi Bio and its partner Coherus was unable to conduct on-site inspections at the facility due to travel restrictions during the epidemic.
Submit an application for drug approval
.
And Chi-Med is because the current data package based on two successful phase III studies in China and a bridging study in the United States is not enough to support the current approval of the drug in the United States
.
Analysts believe that the above cases do not mean that overseas markets have closed the door to domestic innovative drugs
.
The industry believes that this is a reminder that Chinese innovative pharmaceutical companies should focus on the design of clinical trials and the selection of clinical endpoints when listing overseas to cope with the current changing clinical landscape
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
