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Recently, Hengrui issued an announcement stating that it has received a letter from the U.
S.
FDA regarding the approval of the clinical study of SHR-A1904 for injection in the treatment of advanced solid tumors, and will start a phase I/IIa clinical trial in the near future
.
The announcement showed that SHR-A1904 for injection is an antibody-drug conjugate targeting tumor-specific antigens.
By binding to the target antigen on the surface of tumor cells, the drug is endocytosed into the cells and released small molecular toxins to kill tumor cells
.
Up to now, SHR-A1904 related research and development projects have invested a total of about 53.
1 million yuan in research and development expenses
.
It is understood that ADC drugs, antibody-conjugated drugs, combine the high specificity of monoclonal antibody (Antibody) drugs with the high activity of small molecule cytotoxic drugs (Cytotoxic drugs) to improve the targeting of tumor drugs.
Reduce toxic side effects
.
In recent years, with the continuous maturity of ADC drug research and development technology, this market has gradually become hot, and it is attracting more and more companies to enter this field
.
Among them, Hengrui is one of the representatives of domestic pharmaceutical companies actively deploying in the ADC field
.
Since this year, Hengrui has been making continuous efforts in the ADC field
.
As early as January 29, according to the CDE website, Hengrui submitted its first clinical application for its Class 1 new drug "SHR-A1904 for Injection"
.
On August 3, Hengrui declared two more Class 1 innovative drugs: HRS7415 and SHR-A2009
.
According to the code speculation, SHR-A2009 is an ADC product, which is Hengrui's sixth ADC drug declared for clinical use.
The target has not yet been disclosed
.
Industry analysts believe that, in fact, Hengrui's vigorous deployment of the ADC market is based on its optimistic outlook on the ADC drug market
.
According to the estimates of evaluate Pharma and BCG, the global ADC market is expected to reach US$12.
9 billion in 2024
.
Facing the huge ADC drug market, the R&D enthusiasm of domestic pharmaceutical companies has been continuously rising
.
According to ClinicalTrials.
gov, as of March 19, 2021, 29 ADC drug clinical trials are currently underway in China
.
According to incomplete statistics, there are more than 20 domestic companies developing ADC drugs
.
At present, in addition to Hengrui Pharmaceuticals, domestic pharmaceutical companies that have deployed ADC drug research and development include Rongchang Biology, Zhejiang Pharmaceutical's Xinma Biology, Kelun Pharmaceutical's Kelunbotai, and Duoxi Biology, Lepu Biology, and Junshi Biopharmaceutical giants and biotechnology companies
.
From an overall point of view, the industry believes that the current ADC drug target track is already relatively crowded, and the competition on the HER2 track is particularly obvious.
Companies on these tracks are expected to face fierce competition after the products are launched
.
In addition, it should be noted that there are still a group of companies that have already made the decision to "leave the market
.
" For example, in early March of this year, Biotech announced that it had abandoned the clinical development of ADC drugs BAT8003 and monoclonal antibody BAT1306
.
In the previous month, Biotech also announced that another ADC drug BAT8001 phase III clinical trial failed
.
In this regard, the industry believes that although the ADC drug market is currently developing rapidly, there are also many challenges in the development of ADC drugs, including proving the effectiveness of drugs and the toxicity associated with ADC drugs
.
Therefore, while seeing the promising prospects, pharmaceutical companies also need to continue to explore solutions to overcome the challenges in ADC development in order to improve R&D efficiency and benefit more patients
.
S.
FDA regarding the approval of the clinical study of SHR-A1904 for injection in the treatment of advanced solid tumors, and will start a phase I/IIa clinical trial in the near future
.
The announcement showed that SHR-A1904 for injection is an antibody-drug conjugate targeting tumor-specific antigens.
By binding to the target antigen on the surface of tumor cells, the drug is endocytosed into the cells and released small molecular toxins to kill tumor cells
.
Up to now, SHR-A1904 related research and development projects have invested a total of about 53.
1 million yuan in research and development expenses
.
It is understood that ADC drugs, antibody-conjugated drugs, combine the high specificity of monoclonal antibody (Antibody) drugs with the high activity of small molecule cytotoxic drugs (Cytotoxic drugs) to improve the targeting of tumor drugs.
Reduce toxic side effects
.
In recent years, with the continuous maturity of ADC drug research and development technology, this market has gradually become hot, and it is attracting more and more companies to enter this field
.
Among them, Hengrui is one of the representatives of domestic pharmaceutical companies actively deploying in the ADC field
.
Since this year, Hengrui has been making continuous efforts in the ADC field
.
As early as January 29, according to the CDE website, Hengrui submitted its first clinical application for its Class 1 new drug "SHR-A1904 for Injection"
.
On August 3, Hengrui declared two more Class 1 innovative drugs: HRS7415 and SHR-A2009
.
According to the code speculation, SHR-A2009 is an ADC product, which is Hengrui's sixth ADC drug declared for clinical use.
The target has not yet been disclosed
.
Industry analysts believe that, in fact, Hengrui's vigorous deployment of the ADC market is based on its optimistic outlook on the ADC drug market
.
According to the estimates of evaluate Pharma and BCG, the global ADC market is expected to reach US$12.
9 billion in 2024
.
Facing the huge ADC drug market, the R&D enthusiasm of domestic pharmaceutical companies has been continuously rising
.
According to ClinicalTrials.
gov, as of March 19, 2021, 29 ADC drug clinical trials are currently underway in China
.
According to incomplete statistics, there are more than 20 domestic companies developing ADC drugs
.
At present, in addition to Hengrui Pharmaceuticals, domestic pharmaceutical companies that have deployed ADC drug research and development include Rongchang Biology, Zhejiang Pharmaceutical's Xinma Biology, Kelun Pharmaceutical's Kelunbotai, and Duoxi Biology, Lepu Biology, and Junshi Biopharmaceutical giants and biotechnology companies
.
From an overall point of view, the industry believes that the current ADC drug target track is already relatively crowded, and the competition on the HER2 track is particularly obvious.
Companies on these tracks are expected to face fierce competition after the products are launched
.
In addition, it should be noted that there are still a group of companies that have already made the decision to "leave the market
.
" For example, in early March of this year, Biotech announced that it had abandoned the clinical development of ADC drugs BAT8003 and monoclonal antibody BAT1306
.
In the previous month, Biotech also announced that another ADC drug BAT8001 phase III clinical trial failed
.
In this regard, the industry believes that although the ADC drug market is currently developing rapidly, there are also many challenges in the development of ADC drugs, including proving the effectiveness of drugs and the toxicity associated with ADC drugs
.
Therefore, while seeing the promising prospects, pharmaceutical companies also need to continue to explore solutions to overcome the challenges in ADC development in order to improve R&D efficiency and benefit more patients
.