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CAR-T cell therapy is mainly to transfer CAR-T cells cultured in vitro to the human body.
By activating T cells to attack and kill tumor cells in the patient's body, it is a very effective immunotherapy method
.
In recent years, the market demand for CAR-T cell therapy has continued to grow.
The global market size has increased from 10 million U.
S.
dollars in 2017 to approximately 1.
1 billion U.
S.
dollars in 2020.
The market size is expected to reach 21.
8 billion U.
S.
dollars by 2030
.
Due to the broad market prospects of CAR-T cell therapy, it has also attracted many domestic and foreign pharmaceutical companies
.
Up to now, there have been 7 CAR-T drugs approved for marketing worldwide, including Novartis’ Kymriah, Gilead’s Kite’s Yescarta and Tecartus, JunoTherapeutics’s Breyanzi, BMS/BluebirdBio’s Abecma, and WuXi Biotech’s Ruiji Oronza injection and Akilunza injection
.
In addition, facing the $21.
8 billion drug market, the deployment of pharmaceutical companies is accelerating, and clinical progress is accelerating
.
For example, recently there has been new news that Sibiman Biotechnology (hereinafter referred to as "Sibiman") dual-target CAR-T new drug C-CAR039 has been approved by the FDA for its new drug clinical trial (IND) application in the United States.
.
In June of this year, Sibiman announced new clinical research data for C-CAR039 and another cell therapy C-CAR066
.
The results show that these two new CAR-T therapies are expected to bring new hope to patients with relapsed/refractory B-cell non-Hodgkin's lymphoma
.
C-CAR039 is a new CD19/CD20 dual-target CAR-T cell therapy product for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma (r/r B-cell NHL)
.
It is understood that the new clinical data of clinical trials initiated by multi-center researchers in China show that C-CAR039 is used to treat relapsed or refractory B-cell non-Hodgkin’s lymphoma (r/r B-cell NHL).
The overall response rate (ORR) was 92.
6%, of which the complete response rate (CR) reached 85.
2%
.
The results of this clinical study were selected as the oral report at the 2021 American Society of Clinical Oncology (ASCO) annual meeting
.
In June 2021, the U.
S.
FDA granted C-CAR039 orphan drug designation
.
In the domestic CAR-T cell therapy field, there are also a number of pharmaceutical companies that are actively advancing the progress of clinical research and listing
.
For example, Keji Pharmaceutical-B issued an announcement not long ago that the company has received no objection to the clinical trial application of CT041 (an autologous CAR T cell candidate product for claudin18.
2 protein (CLDN18.
2)) from Health Canada.
According to the letter, CT041 has also become the world’s first CAR T cell candidate product that has been approved by the US FDA, the National Food and Drug Administration and Health Canada’s IND and is undergoing clinical trials to target CLDN 18.
2
.
The company believes that CT041 may become the backbone therapy for gastric cancer and pancreatic cancer in the future and benefit a large number of patient groups worldwide
.
On November 2 this year, Legend Biological announced that the US FDA has extended the PDUFA target date for the CAR-T product Cilta-cel developed by the company.
The approval period will be changed from the original November 2021.
The 29th was postponed to February 28, 2022
.
It is reported that after the product goes on the market, it will become the 8th approved CAR-T drug in the world
.
Data show that there are more than 700 CAR-T clinical projects registered on clinicaltrials.
gov worldwide.
In addition to malignant hematological diseases, there are also solid tumors such as pancreatic cancer, liver cancer, lung cancer, breast cancer, and colorectal cancer
.
Throughout the country, there are also nearly 40 CAR-T therapies under development
.
Among them, Novartis’ Kymriah has entered Phase III clinical trials in China, and companies such as Heyuan Bio, Legend Biology, and Keji Biology have also entered mid-clinical phases
.
The industry predicts that the next dual-target CAR-T therapy will become a track for companies to compete
.
By activating T cells to attack and kill tumor cells in the patient's body, it is a very effective immunotherapy method
.
In recent years, the market demand for CAR-T cell therapy has continued to grow.
The global market size has increased from 10 million U.
S.
dollars in 2017 to approximately 1.
1 billion U.
S.
dollars in 2020.
The market size is expected to reach 21.
8 billion U.
S.
dollars by 2030
.
Due to the broad market prospects of CAR-T cell therapy, it has also attracted many domestic and foreign pharmaceutical companies
.
Up to now, there have been 7 CAR-T drugs approved for marketing worldwide, including Novartis’ Kymriah, Gilead’s Kite’s Yescarta and Tecartus, JunoTherapeutics’s Breyanzi, BMS/BluebirdBio’s Abecma, and WuXi Biotech’s Ruiji Oronza injection and Akilunza injection
.
In addition, facing the $21.
8 billion drug market, the deployment of pharmaceutical companies is accelerating, and clinical progress is accelerating
.
For example, recently there has been new news that Sibiman Biotechnology (hereinafter referred to as "Sibiman") dual-target CAR-T new drug C-CAR039 has been approved by the FDA for its new drug clinical trial (IND) application in the United States.
.
In June of this year, Sibiman announced new clinical research data for C-CAR039 and another cell therapy C-CAR066
.
The results show that these two new CAR-T therapies are expected to bring new hope to patients with relapsed/refractory B-cell non-Hodgkin's lymphoma
.
C-CAR039 is a new CD19/CD20 dual-target CAR-T cell therapy product for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma (r/r B-cell NHL)
.
It is understood that the new clinical data of clinical trials initiated by multi-center researchers in China show that C-CAR039 is used to treat relapsed or refractory B-cell non-Hodgkin’s lymphoma (r/r B-cell NHL).
The overall response rate (ORR) was 92.
6%, of which the complete response rate (CR) reached 85.
2%
.
The results of this clinical study were selected as the oral report at the 2021 American Society of Clinical Oncology (ASCO) annual meeting
.
In June 2021, the U.
S.
FDA granted C-CAR039 orphan drug designation
.
In the domestic CAR-T cell therapy field, there are also a number of pharmaceutical companies that are actively advancing the progress of clinical research and listing
.
For example, Keji Pharmaceutical-B issued an announcement not long ago that the company has received no objection to the clinical trial application of CT041 (an autologous CAR T cell candidate product for claudin18.
2 protein (CLDN18.
2)) from Health Canada.
According to the letter, CT041 has also become the world’s first CAR T cell candidate product that has been approved by the US FDA, the National Food and Drug Administration and Health Canada’s IND and is undergoing clinical trials to target CLDN 18.
2
.
The company believes that CT041 may become the backbone therapy for gastric cancer and pancreatic cancer in the future and benefit a large number of patient groups worldwide
.
On November 2 this year, Legend Biological announced that the US FDA has extended the PDUFA target date for the CAR-T product Cilta-cel developed by the company.
The approval period will be changed from the original November 2021.
The 29th was postponed to February 28, 2022
.
It is reported that after the product goes on the market, it will become the 8th approved CAR-T drug in the world
.
Data show that there are more than 700 CAR-T clinical projects registered on clinicaltrials.
gov worldwide.
In addition to malignant hematological diseases, there are also solid tumors such as pancreatic cancer, liver cancer, lung cancer, breast cancer, and colorectal cancer
.
Throughout the country, there are also nearly 40 CAR-T therapies under development
.
Among them, Novartis’ Kymriah has entered Phase III clinical trials in China, and companies such as Heyuan Bio, Legend Biology, and Keji Biology have also entered mid-clinical phases
.
The industry predicts that the next dual-target CAR-T therapy will become a track for companies to compete
.
