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Due to its prominent advantages, tumor immunotherapy is becoming an important direction for clinical targeted drug development.
In recent years, more and more tumor immunotherapy gene targets have entered the field of research and development.
Among them, CTLA-4 inhibitors are also targets for tumor immune drug development.
One of the popular targets
.
It, together with PD-1 and PD-L1, is called the "three treasures" of tumor immune drug development targets, but unlike the latter, the CTLA-4 track has a good competition pattern.
At present, there are 32 CTLA-4 targets in the world.
Order the drug under development
.
Among them, only Bristol-Myers Squibb's ipilimumab (Y drug) has been approved for marketing in China, and many local pharmaceutical companies are competing for biosimilar drugs
.
It is understood that the price of CTLA-4 antibody drugs is relatively favorable, and the economic burden of patients is relatively small.
The global market demand for CTLA-4 antibody drugs is growing, and the industry market scale will continue to expand
.
Data show that the global CTLA-4 antibody drug market has increased from US$1.
1 billion in 2016 to US$1.
7 billion in 2020, with a compound annual growth rate of 12.
4%
.
The market is expected to reach US$2 billion in 2021
.
Among them, in China, the anti-CTLA-4 drug market is expected to reach US$1.
7 billion in 2030.
From 2024 to 2030, the compound annual growth rate is expected to exceed 30%
.
Facing such a potential market, domestic and foreign pharmaceutical companies are actively deploying
.
However, judging from the current status of CTLA-4 research in China, most pharmaceutical companies are currently in the phase I or phase II clinical phases of drugs under research in the direction of CTLA-4 targets, and their progress is relatively slow, and they will become competitive before they are successfully launched.
The products still have a long way to go
.
Hengrui Medicine announced on the evening of November 21 that it had reached a strategic cooperation and exclusive license agreement with CStone Pharmaceuticals on the anti-CTLA-4 monoclonal antibody CS1002 in the Greater China region
.
According to the agreement, Hengrui Pharmaceuticals will pay CStone Pharmaceuticals about 1.
3 billion yuan in down payment and milestone payments, and CStone Pharmaceuticals will grant Hengrui Pharmaceuticals the research and development, registration, production and commercialization of anti-CTLA-4 monoclonal antibody CS1002 in Greater China.
Exclusive right, permitted use for all human and animal diseases
.
This time, Hengrui Medicine participated in the competition track of tumor drug anti-CTLA-4 monoclonal antibody in the form of license-in
.
The announcement shows that the CS1002 introduced this time is one of the few clinically proven targets for tumor immunotherapy.
It is currently undergoing phase I clinical trials in China and Australia
.
Studies have found that CS1002 can block CTLA-4 mediated immunosuppressive response by combining with CTLA-4, and at the same time down-regulate Treg's suppression of immune response, thereby enhancing the anti-tumor immune effect
.
Hengrui Pharmaceuticals announced that in October 2021, AstraZeneca announced that its anti-CTLA-4 monoclonal antibody tremelimumab combined with Imfinzi (anti-PD-L1 monoclonal antibody) vs.
sorafenib will be a phase III clinical study for the first-line treatment of advanced hepatocellular carcinoma.
To reach the primary endpoint of overall survival
.
Innovent's anti-CTLA-4 monoclonal antibody IBI310 combined with Sintilimab (anti-PD-1 monoclonal antibody) versus sorafenib, a phase III clinical trial for the first-line treatment of advanced hepatocellular carcinoma was launched in 2021
.
The industry believes that Hengrui Medicine's Karelizumab is an anti-PD-1 antibody with the majority of approved indications in China.
The cooperation with CStone Pharmaceuticals is also based on the consideration of combination drugs
.
In addition to Hengrui Pharmaceuticals, there are also many domestic pharmaceutical companies participating in the research and development of CTLA-4
.
According to the Dingxiangyuan Insight database, a total of 36 companies have participated in the clinical research and development of CTLA-4 targets, and more than 20 models are in the registration/critical clinical trial stage
.
Among them, Kangfang Bio-PD-1/CTLA-4 dual anti-cervical cancer application was accepted in September this year
.
In the field of monoclonal antibodies, Innovent's IBI-310 is the first domestic CTLA-4 inhibitor that has advanced to clinical phase III
.
In recent years, more and more tumor immunotherapy gene targets have entered the field of research and development.
Among them, CTLA-4 inhibitors are also targets for tumor immune drug development.
One of the popular targets
.
It, together with PD-1 and PD-L1, is called the "three treasures" of tumor immune drug development targets, but unlike the latter, the CTLA-4 track has a good competition pattern.
At present, there are 32 CTLA-4 targets in the world.
Order the drug under development
.
Among them, only Bristol-Myers Squibb's ipilimumab (Y drug) has been approved for marketing in China, and many local pharmaceutical companies are competing for biosimilar drugs
.
It is understood that the price of CTLA-4 antibody drugs is relatively favorable, and the economic burden of patients is relatively small.
The global market demand for CTLA-4 antibody drugs is growing, and the industry market scale will continue to expand
.
Data show that the global CTLA-4 antibody drug market has increased from US$1.
1 billion in 2016 to US$1.
7 billion in 2020, with a compound annual growth rate of 12.
4%
.
The market is expected to reach US$2 billion in 2021
.
Among them, in China, the anti-CTLA-4 drug market is expected to reach US$1.
7 billion in 2030.
From 2024 to 2030, the compound annual growth rate is expected to exceed 30%
.
Facing such a potential market, domestic and foreign pharmaceutical companies are actively deploying
.
However, judging from the current status of CTLA-4 research in China, most pharmaceutical companies are currently in the phase I or phase II clinical phases of drugs under research in the direction of CTLA-4 targets, and their progress is relatively slow, and they will become competitive before they are successfully launched.
The products still have a long way to go
.
Hengrui Medicine announced on the evening of November 21 that it had reached a strategic cooperation and exclusive license agreement with CStone Pharmaceuticals on the anti-CTLA-4 monoclonal antibody CS1002 in the Greater China region
.
According to the agreement, Hengrui Pharmaceuticals will pay CStone Pharmaceuticals about 1.
3 billion yuan in down payment and milestone payments, and CStone Pharmaceuticals will grant Hengrui Pharmaceuticals the research and development, registration, production and commercialization of anti-CTLA-4 monoclonal antibody CS1002 in Greater China.
Exclusive right, permitted use for all human and animal diseases
.
This time, Hengrui Medicine participated in the competition track of tumor drug anti-CTLA-4 monoclonal antibody in the form of license-in
.
The announcement shows that the CS1002 introduced this time is one of the few clinically proven targets for tumor immunotherapy.
It is currently undergoing phase I clinical trials in China and Australia
.
Studies have found that CS1002 can block CTLA-4 mediated immunosuppressive response by combining with CTLA-4, and at the same time down-regulate Treg's suppression of immune response, thereby enhancing the anti-tumor immune effect
.
Hengrui Pharmaceuticals announced that in October 2021, AstraZeneca announced that its anti-CTLA-4 monoclonal antibody tremelimumab combined with Imfinzi (anti-PD-L1 monoclonal antibody) vs.
sorafenib will be a phase III clinical study for the first-line treatment of advanced hepatocellular carcinoma.
To reach the primary endpoint of overall survival
.
Innovent's anti-CTLA-4 monoclonal antibody IBI310 combined with Sintilimab (anti-PD-1 monoclonal antibody) versus sorafenib, a phase III clinical trial for the first-line treatment of advanced hepatocellular carcinoma was launched in 2021
.
The industry believes that Hengrui Medicine's Karelizumab is an anti-PD-1 antibody with the majority of approved indications in China.
The cooperation with CStone Pharmaceuticals is also based on the consideration of combination drugs
.
In addition to Hengrui Pharmaceuticals, there are also many domestic pharmaceutical companies participating in the research and development of CTLA-4
.
According to the Dingxiangyuan Insight database, a total of 36 companies have participated in the clinical research and development of CTLA-4 targets, and more than 20 models are in the registration/critical clinical trial stage
.
Among them, Kangfang Bio-PD-1/CTLA-4 dual anti-cervical cancer application was accepted in September this year
.
In the field of monoclonal antibodies, Innovent's IBI-310 is the first domestic CTLA-4 inhibitor that has advanced to clinical phase III
.
