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[Pharmaceutical Network Market Analysis] "The domestic market is limited, and overseas is the sea of stars", the industry said, whether it is innovative drugs or generic drugs, the industry's endogenous demand has forced companies to participate in globalizati.
It is understood that in recent years, the progress of generic drugs overseas has accelerat.
According to statistics, the number of ANDAs obtained by Chinese generic drugs has continued to rise over the years, and the sales of overseas generic drugs of some companies are higher than domestic sal.
In addition, there are constant news that some pharmaceutical products have been approved abro.
Taking Huiyu Pharmaceutical as an example, in May this year, Huiyu Pharmaceutical's concentrated solution of oxaliplatin for injection was approved for registration in Germa.
In June, Huiyu Pharmaceutical's Plerixafor injection was approved for registration in the UK, making it the first company to obtain approval for this generic drug in the .
Up to now, Huiyu Pharmaceutical's 4 injections including Sodium Valproate Injection Concentrated Solution, Levetiracetam Injection Concentrated Solution, Octreotide Acetate Injection, and Plerixafor Injection have successively obtained registration approvals in the .
The company owns 15 approved products in the UK mark.
At the same time, in addition to the United Kingdom, Plerixafor injection has also submitted registration declarations in many countries, including China, and more than 20 European and North American countries such as Ireland, Germany, Spain, France, Poland, the Netherlands, Italy, and Cana.
In addition, Hengrui Medicine's generic drugs have also ushered in new progress in internationalizati.
At the end of May this year, Hengrui Medicine's iodixanol was approved in the ANDA (generic drug listing) application in the United Stat.
After this approval, according to the US CGT (competitive generic therapy) Act, Hengrui Medicine Iodixanol injection will obtain a 180-day market exclusivity period, and is expected to become a product of Hengrui Medicine with overseas sales of over US$100 milli.
It is reported that from 2000 to 2015, many leading pharmaceutical companies gradually tried to seek the development of overseas marke.
Since July 2015, the National Drug Administration has issued a series of policies and measures to encourage the research and development of new drugs, and strengthen the connection between China's drug regulatory regulations and the international market, creating more possibilities for domestic pharmaceutical companies to expand overseas marke.
In recent years, after years of national procurement and medical insurance negotiations in China, the market competition pattern is generally clear, and the exchange of quantity for price is requiring each pharmaceutical company to be more pragmat.
In this context, the "involution" of the domestic generic drug market has intensified, and the speed of "going out" is accelerati.
Analysts pointed out that in recent years, under the pressure of policies such as high pressure on environmental protection and consistency evaluation, the quality standards of generic drugs in China have been continuously improv.
It is gaining more competitiveness in the global market, and the export prospects are starting to grow wid.
In the overseas market, the first generic drugs have become the main directi.
For example, in 2014, Prasugrel from Sunshine Pharmaceuticals became the first generic drug approved in the United States in Chi.
In 2017, Huahai Pharmaceutical's Paroxetine Capsules became the first generic drug in China to successfully challenge PIV in the United Stat.
According to the industry, with the continuous advancement of the consistency evaluation of generic drugs, the strength of Chinese enterprises to develop generic drugs in accordance with the unified technical standards and the global evaluation system of the International Human Drug Registration Technology Harmonization System is constantly increasi.
It is believed that the first generic drugs with high barriers to R&D and production will also become the main direction of the development of Chinese pharmaceutical companies in overseas marke.
In addition, in response to the development of the overseas market of generic drugs, the industry said that on the one hand, international mergers and acquisitions and capital operations are needed, among which international mergers and acquisitions are the accelerators for the international development of enterprises; A complete industrial ecosystem of R&D, production and sales has been formed, which has paved the way for Indian companies' products from development to commercializati.
Reflecting on China's generic drugs going overseas, how to choose the sales model for approved products, and how to quickly solve various regulatory issues after listing, all need further thinki.
Today, China is promoting the consistency evaluation of generic drugs, which will also force Chinese pharmaceutical companies to pay attention to improving their R&D capabilities, process capabilities and quality management capabilities, and objectively promote the integration with international standar.
According to the industry, with the continuous improvement of the quality of domestic generic drugs, the export of domestic generic drugs will also go to the "blue ocea.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyo.
It is understood that in recent years, the progress of generic drugs overseas has accelerat.
According to statistics, the number of ANDAs obtained by Chinese generic drugs has continued to rise over the years, and the sales of overseas generic drugs of some companies are higher than domestic sal.
In addition, there are constant news that some pharmaceutical products have been approved abro.
Taking Huiyu Pharmaceutical as an example, in May this year, Huiyu Pharmaceutical's concentrated solution of oxaliplatin for injection was approved for registration in Germa.
In June, Huiyu Pharmaceutical's Plerixafor injection was approved for registration in the UK, making it the first company to obtain approval for this generic drug in the .
Up to now, Huiyu Pharmaceutical's 4 injections including Sodium Valproate Injection Concentrated Solution, Levetiracetam Injection Concentrated Solution, Octreotide Acetate Injection, and Plerixafor Injection have successively obtained registration approvals in the .
The company owns 15 approved products in the UK mark.
At the same time, in addition to the United Kingdom, Plerixafor injection has also submitted registration declarations in many countries, including China, and more than 20 European and North American countries such as Ireland, Germany, Spain, France, Poland, the Netherlands, Italy, and Cana.
In addition, Hengrui Medicine's generic drugs have also ushered in new progress in internationalizati.
At the end of May this year, Hengrui Medicine's iodixanol was approved in the ANDA (generic drug listing) application in the United Stat.
After this approval, according to the US CGT (competitive generic therapy) Act, Hengrui Medicine Iodixanol injection will obtain a 180-day market exclusivity period, and is expected to become a product of Hengrui Medicine with overseas sales of over US$100 milli.
It is reported that from 2000 to 2015, many leading pharmaceutical companies gradually tried to seek the development of overseas marke.
Since July 2015, the National Drug Administration has issued a series of policies and measures to encourage the research and development of new drugs, and strengthen the connection between China's drug regulatory regulations and the international market, creating more possibilities for domestic pharmaceutical companies to expand overseas marke.
In recent years, after years of national procurement and medical insurance negotiations in China, the market competition pattern is generally clear, and the exchange of quantity for price is requiring each pharmaceutical company to be more pragmat.
In this context, the "involution" of the domestic generic drug market has intensified, and the speed of "going out" is accelerati.
Analysts pointed out that in recent years, under the pressure of policies such as high pressure on environmental protection and consistency evaluation, the quality standards of generic drugs in China have been continuously improv.
It is gaining more competitiveness in the global market, and the export prospects are starting to grow wid.
In the overseas market, the first generic drugs have become the main directi.
For example, in 2014, Prasugrel from Sunshine Pharmaceuticals became the first generic drug approved in the United States in Chi.
In 2017, Huahai Pharmaceutical's Paroxetine Capsules became the first generic drug in China to successfully challenge PIV in the United Stat.
According to the industry, with the continuous advancement of the consistency evaluation of generic drugs, the strength of Chinese enterprises to develop generic drugs in accordance with the unified technical standards and the global evaluation system of the International Human Drug Registration Technology Harmonization System is constantly increasi.
It is believed that the first generic drugs with high barriers to R&D and production will also become the main direction of the development of Chinese pharmaceutical companies in overseas marke.
In addition, in response to the development of the overseas market of generic drugs, the industry said that on the one hand, international mergers and acquisitions and capital operations are needed, among which international mergers and acquisitions are the accelerators for the international development of enterprises; A complete industrial ecosystem of R&D, production and sales has been formed, which has paved the way for Indian companies' products from development to commercializati.
Reflecting on China's generic drugs going overseas, how to choose the sales model for approved products, and how to quickly solve various regulatory issues after listing, all need further thinki.
Today, China is promoting the consistency evaluation of generic drugs, which will also force Chinese pharmaceutical companies to pay attention to improving their R&D capabilities, process capabilities and quality management capabilities, and objectively promote the integration with international standar.
According to the industry, with the continuous improvement of the quality of domestic generic drugs, the export of domestic generic drugs will also go to the "blue ocea.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyo.
