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Recently, Henlius announced that its self-developed innovative biopharmaceutical PD-1 inhibitor H drug-Hanszoid® (generic name: slulimumab injection) was officially approved by the State Food and Drug Administration for use in Indications for adults with advanced solid tumors with unresectable or metastatic microsatellite instability-high (MSI-H) who have failed previous standard therapy
.
According to public information, the drug is the first innovative monoclonal antibody independently developed by Henlius, commonly known as "H drug" in the industry
.
The product is approved for the treatment of microsatellite highly unstable (MSI-H) solid tumors
.
Previously, Drug H has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions, and 9 clinical trials of tumor immunotherapy combination therapy have been carried out simultaneously around the world, covering a wide range of indications such as lung cancer, esophageal cancer, head and neck cancer, and gastric cancer, covering First-line treatment of lung cancer
.
It is worth noting that with the approval of Henlius’ slulimumab, up to now, a total of 13 PD-(L)1 mAbs have been approved in China, of which domestic PD-1 mAbs are There are 7 in total
.
It is understood that, in recent years, PD-(L)1 is not only a broad-spectrum anticancer drug, but also can treat many types of cancer, and it is also the cornerstone drug of immunotherapy.
The effect has attracted a large number of enterprises to start to develop PD-(L)1 products
.
Since the first domestic PD-1 was approved for listing in December 2018, more than three years later, the PD-(L)1 market has welcomed more than ten products
.
It is worth noting that according to the data, there are currently 5683 clinical trials evaluating PD1/PDL1 mAbs as monotherapy or in combination with other therapies, of which 4897 are active
.
Industry analysts believe that compared with 2017, the total number of clinical trials in the past five years has increased by 278%
.
Pharmaceutical companies get together in the PD-(L)1 field, which is undoubtedly optimistic about its development prospects
.
According to Frost & Sullivan, the global market for PD-(L)1 inhibitors was US$16.
3 billion in 2018 and is expected to reach US$63.
9 billion by 2023
.
In China, the market size of PD-(L)1 inhibitors is expected to reach 66.
4 billion yuan in 2023 and grow to 98.
8 billion yuan in 2030
.
However, although the market has a broad space for development, industry insiders also pointed out that as more and more PD-(L)1 products are developed and marketed, bringing more new treatment options to the majority of patients, the competition in this track will also More and more intense, it is understood that there are already 70 PD-(L)1 drugs and drug candidates entering the clinical stage in China
.
As the competition for PD-(L)1 continues to intensify, where is the way out for local pharmaceutical companies, and how can they improve their competitiveness? In this regard, the analysis believes that the domestic market competition is fierce, and PD-(L)1 enterprises seeking overseas opportunities will become an important part of the strategic layout of each company
.
According to the author's understanding, domestic PD-1 companies such as Innovent Bio, Junshi Bio, BeiGene, and Kangfang Bio have all submitted listing applications to the FDA
.
It should be noted that, at the same time, some people in the industry also pointed out that pharmaceutical companies need to do two things if they want to go overseas: on the one hand, they must operate in compliance with the regulatory requirements of various countries; on the other hand, internationalization must be steady and steady, not Eager for success
.
In general, domestic PD-(L)1 is facing greater competitive pressure
.
In the PD-1 market, the drugs that will be subsequently declared are Genozumab (Jiahe Bio) and Putlimumab (Lepu Bio)
.
Among them, Jiahe Biotech submitted its NDA only 2 months later than Kangfang/Tianqing's piamprilumab, and it is expected to be approved within this year
.
In addition, there are a number of PD-(L)1 models that are also lining up for approval
.
In the context of increasing competition, PD-1 may become a new breakthrough point for domestic pharmaceutical companies to go overseas
.
However, with the continuous tightening of FDA's review and approval, the industry believes that in the future, products with differentiated and better efficacy can truly stand out
.
In addition, how to break through the competition in the future, how to find differentiated development, how to truly solve clinical pain points, and meet unmet clinical needs will also become whether PD-(L)1 R&D pharmaceutical companies can stand out in the fierce competition key
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
According to public information, the drug is the first innovative monoclonal antibody independently developed by Henlius, commonly known as "H drug" in the industry
.
The product is approved for the treatment of microsatellite highly unstable (MSI-H) solid tumors
.
Previously, Drug H has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions, and 9 clinical trials of tumor immunotherapy combination therapy have been carried out simultaneously around the world, covering a wide range of indications such as lung cancer, esophageal cancer, head and neck cancer, and gastric cancer, covering First-line treatment of lung cancer
.
It is worth noting that with the approval of Henlius’ slulimumab, up to now, a total of 13 PD-(L)1 mAbs have been approved in China, of which domestic PD-1 mAbs are There are 7 in total
.
It is understood that, in recent years, PD-(L)1 is not only a broad-spectrum anticancer drug, but also can treat many types of cancer, and it is also the cornerstone drug of immunotherapy.
The effect has attracted a large number of enterprises to start to develop PD-(L)1 products
.
Since the first domestic PD-1 was approved for listing in December 2018, more than three years later, the PD-(L)1 market has welcomed more than ten products
.
It is worth noting that according to the data, there are currently 5683 clinical trials evaluating PD1/PDL1 mAbs as monotherapy or in combination with other therapies, of which 4897 are active
.
Industry analysts believe that compared with 2017, the total number of clinical trials in the past five years has increased by 278%
.
Pharmaceutical companies get together in the PD-(L)1 field, which is undoubtedly optimistic about its development prospects
.
According to Frost & Sullivan, the global market for PD-(L)1 inhibitors was US$16.
3 billion in 2018 and is expected to reach US$63.
9 billion by 2023
.
In China, the market size of PD-(L)1 inhibitors is expected to reach 66.
4 billion yuan in 2023 and grow to 98.
8 billion yuan in 2030
.
However, although the market has a broad space for development, industry insiders also pointed out that as more and more PD-(L)1 products are developed and marketed, bringing more new treatment options to the majority of patients, the competition in this track will also More and more intense, it is understood that there are already 70 PD-(L)1 drugs and drug candidates entering the clinical stage in China
.
As the competition for PD-(L)1 continues to intensify, where is the way out for local pharmaceutical companies, and how can they improve their competitiveness? In this regard, the analysis believes that the domestic market competition is fierce, and PD-(L)1 enterprises seeking overseas opportunities will become an important part of the strategic layout of each company
.
According to the author's understanding, domestic PD-1 companies such as Innovent Bio, Junshi Bio, BeiGene, and Kangfang Bio have all submitted listing applications to the FDA
.
It should be noted that, at the same time, some people in the industry also pointed out that pharmaceutical companies need to do two things if they want to go overseas: on the one hand, they must operate in compliance with the regulatory requirements of various countries; on the other hand, internationalization must be steady and steady, not Eager for success
.
In general, domestic PD-(L)1 is facing greater competitive pressure
.
In the PD-1 market, the drugs that will be subsequently declared are Genozumab (Jiahe Bio) and Putlimumab (Lepu Bio)
.
Among them, Jiahe Biotech submitted its NDA only 2 months later than Kangfang/Tianqing's piamprilumab, and it is expected to be approved within this year
.
In addition, there are a number of PD-(L)1 models that are also lining up for approval
.
In the context of increasing competition, PD-1 may become a new breakthrough point for domestic pharmaceutical companies to go overseas
.
However, with the continuous tightening of FDA's review and approval, the industry believes that in the future, products with differentiated and better efficacy can truly stand out
.
In addition, how to break through the competition in the future, how to find differentiated development, how to truly solve clinical pain points, and meet unmet clinical needs will also become whether PD-(L)1 R&D pharmaceutical companies can stand out in the fierce competition key
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
