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In recent years, affected by the domestic pharmaceutical reform, many pharmaceutical companies have begun to choose to focus on overseas markets
.
More and more companies have accelerated their pace of internationalization, including local companies such as Hengrui Medicine, BeiGene, and Innovent Bio, as well as emerging pharmaceutical companies such as Tianjing Bio, Ruige Medicine, and Clover Bio.
.
With the efforts of many pharmaceutical companies, some data show that in 2021, the overseas authorization transactions of domestic innovative pharmaceutical companies, namely License out, will continue to climax
.
It is worth noting that since the beginning of this year, with the continuous acceleration of local pharmaceutical companies to go overseas, many products have made a lot of important progress in global expansion
.
Recently, BeiGene announced that the Marketing Authorization Application (MAA) of its self-developed PD-1 monoclonal antibody Baizean® (generic name: Tislelizumab injection) was officially accepted by the European Medicines Agency (EMA).
For the treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) and non-small cell lung cancer (NSCLC) who have received prior systemic chemotherapy
.
This is the first application of Baizean® in Europe, and it is also another important progress in the global expansion of Baizean® after being accepted by the U.
S.
Food and Drug Administration (FDA)
.
According to public information, on September 13, 2021, BeiGene announced that the new drug marketing application (BLA) of its self-developed PD-1 monoclonal antibody Baizean® has been officially accepted by the U.
S.
Food and Drug Administration (FDA).
For the treatment of unresectable, recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after previous systemic therapy
.
It is foreseeable that with the continuous development of overseas declarations, the globalization process of Baizean will continue to accelerate
.
In fact, with the rise of the strength of domestic innovative drugs and the intensification of competition in the domestic market, in recent years, in addition to BeiGene's Baizean®, many domestic innovative drugs are also speeding up to go overseas
.
In March of this year, "Legend Bio" obtained the US FDA (Food and Drug Administration) marketing authorization for its self-developed CAR-T product, Sidajiorenza, for the treatment of relapsed/refractory multiple myeloma (r /r MM) patients
.
It is reported that Cidaki Orenza is a chimeric antigen receptor T-cell (CAR-T) therapy.
The CAR-T therapy drug Akirenza, which was introduced by Fosun Pharma in June last year, has also been officially approved in China.
.
As the first domestic CAR-T cell therapy approved by the FDA, Legend Bio's Sidaki Orenza is a milestone in the level of domestic innovative drugs going overseas, and it has also injected another dimension into the domestic innovative drug track.
Acupuncture cardiotonic
.
In addition to Legend Bio, last 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
.
In this regard, analysts believe that from the current point of view, Chinese innovative drugs with real clinical value are still promising
.
Only when pharmaceutical companies have real materials can they go through rigorous audits and move towards a wider world
.
Therefore, in the future, the correct posture for China's innovative drugs to go overseas will be to make good use of their own advantages down-to-earth, so as to have more opportunities to compete with the strong
.
It is worth noting that under the background of a large number of pharmaceutical companies accelerating their overseas expansion, there are three types of companies worthy of attention.
The first is companies with strong funds, sufficient courage and confidence to promote Phase 3 clinical trials overseas, mainly in the European and American markets.
Jeshenzhou, Hengrui Medicine,
etc.
Secondly, the products are highly scarce, or have outstanding clinical efficacy, and have the potential to authorize varieties to MNC companies, such as Legend Bio, Kangfang Bio, and Innovent Bio
.
Third, companies that can supplement the unmet clinical needs of Europe and the United States, such as Junshi Biotechnology and Chi-Med Pharmaceuticals
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
More and more companies have accelerated their pace of internationalization, including local companies such as Hengrui Medicine, BeiGene, and Innovent Bio, as well as emerging pharmaceutical companies such as Tianjing Bio, Ruige Medicine, and Clover Bio.
.
With the efforts of many pharmaceutical companies, some data show that in 2021, the overseas authorization transactions of domestic innovative pharmaceutical companies, namely License out, will continue to climax
.
It is worth noting that since the beginning of this year, with the continuous acceleration of local pharmaceutical companies to go overseas, many products have made a lot of important progress in global expansion
.
Recently, BeiGene announced that the Marketing Authorization Application (MAA) of its self-developed PD-1 monoclonal antibody Baizean® (generic name: Tislelizumab injection) was officially accepted by the European Medicines Agency (EMA).
For the treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) and non-small cell lung cancer (NSCLC) who have received prior systemic chemotherapy
.
This is the first application of Baizean® in Europe, and it is also another important progress in the global expansion of Baizean® after being accepted by the U.
S.
Food and Drug Administration (FDA)
.
According to public information, on September 13, 2021, BeiGene announced that the new drug marketing application (BLA) of its self-developed PD-1 monoclonal antibody Baizean® has been officially accepted by the U.
S.
Food and Drug Administration (FDA).
For the treatment of unresectable, recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after previous systemic therapy
.
It is foreseeable that with the continuous development of overseas declarations, the globalization process of Baizean will continue to accelerate
.
In fact, with the rise of the strength of domestic innovative drugs and the intensification of competition in the domestic market, in recent years, in addition to BeiGene's Baizean®, many domestic innovative drugs are also speeding up to go overseas
.
In March of this year, "Legend Bio" obtained the US FDA (Food and Drug Administration) marketing authorization for its self-developed CAR-T product, Sidajiorenza, for the treatment of relapsed/refractory multiple myeloma (r /r MM) patients
.
It is reported that Cidaki Orenza is a chimeric antigen receptor T-cell (CAR-T) therapy.
The CAR-T therapy drug Akirenza, which was introduced by Fosun Pharma in June last year, has also been officially approved in China.
.
As the first domestic CAR-T cell therapy approved by the FDA, Legend Bio's Sidaki Orenza is a milestone in the level of domestic innovative drugs going overseas, and it has also injected another dimension into the domestic innovative drug track.
Acupuncture cardiotonic
.
In addition to Legend Bio, last 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
.
In this regard, analysts believe that from the current point of view, Chinese innovative drugs with real clinical value are still promising
.
Only when pharmaceutical companies have real materials can they go through rigorous audits and move towards a wider world
.
Therefore, in the future, the correct posture for China's innovative drugs to go overseas will be to make good use of their own advantages down-to-earth, so as to have more opportunities to compete with the strong
.
It is worth noting that under the background of a large number of pharmaceutical companies accelerating their overseas expansion, there are three types of companies worthy of attention.
The first is companies with strong funds, sufficient courage and confidence to promote Phase 3 clinical trials overseas, mainly in the European and American markets.
Jeshenzhou, Hengrui Medicine,
etc.
Secondly, the products are highly scarce, or have outstanding clinical efficacy, and have the potential to authorize varieties to MNC companies, such as Legend Bio, Kangfang Bio, and Innovent Bio
.
Third, companies that can supplement the unmet clinical needs of Europe and the United States, such as Junshi Biotechnology and Chi-Med Pharmaceuticals
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
