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CAR-T cell immunotherapy is the abbreviation of chimeric antigen receptor T cell therapy.
It kills tumor cells and has the effect of treating corresponding hematological malignancies
.
Due to its great advantages in the treatment of hematological malignancies, CAR-T cell immunotherapy has become a hot research focus in recent years
.
From the perspective of the global CAR-T cell immunotherapy industry, China is catching up with the United States, especially since the adjustment stage in 2016, with the introduction of the guiding principles in 2017, the number of applications for CAR-T cell immunotherapy patents has greatly increased
.
At the same time, the approval of domestic new drug clinical research has accelerated.
Data shows that from 2020 to 2021, the number of INDs for cell therapy products in the United States will increase from 479 to 654, and the number of INDs for such products in China will increase from 264 to 420.
.
These data all prove the rise of domestic CAR-T cell immunotherapy
.
At present, in the field of CAR-T cell immunotherapy in China, there are not only a large number of companies that cooperate with large overseas pharmaceutical companies to introduce mature products and localize production, but also some local pharmaceutical companies that take the road of independent research and development, such as Shanghai Cell Group, Keji Biotechnology , Gracell Bio,
etc.
At the same time, in recent years, with the improvement of local innovation strength, some local pharmaceutical companies are also accelerating their international layout while facing the huge domestic cancer market demand
.
Recently, Keji Bio announced that the cGMP production plant built by the company's American company CARsgen Therapeutics Corporation in the Research Triangle Park (RTP) area of North Carolina, USA, has passed local inspections
.
Keji Pharmaceutical has obtained a compliance certificate issued by the Durham City and County Inspection Bureau and has started clinical production operations
.
It is reported that the factory is the first factory outside of China to start operation in the world of Keji Bio, which means that the company's global layout has reached a higher level
.
It is understood that the cGMP production plant of Keji Bio adopts an integrated project delivery method, which greatly shortens the construction period and improves cost-effectiveness..
The factory has a total construction area of about 3,300 square meters and can serve 700 patients per year.
It will greatly enhance the production capacity of Keji Pharmaceutical's autologous CAR-T cell products, and will support the company's clinical research and early commercialization in North America and Europe.
.
The project has received support from the Talent Development Investment Fund (JDIG) and other investment incentives from Durham County and the City of Durham, North Carolina, USA
.
In addition, in order to accelerate the clinical production of the RTP production plant, Keji Pharmaceutical's GMP production plant in Jinshan District, Shanghai, China will continue to conduct FDA-approved IND clinical studies in the United States for the company's two core product candidates, CT053 and CT041, to provide manufacturing Lentiviral vector material for CAR-T cell products
.
The large-scale production of viral vector material at its Jinshan production facility is expected to reduce the manufacturing cost of CAR-T cell products and improve patient accessibility
.
According to public information, Keji Bio is a biopharmaceutical company with operations in China and the United States, mainly focusing on innovative CAR-T cell therapy for the treatment of hematological malignancies and solid tumors
.
The company has built an integrated cell therapy platform with in-house capabilities ranging from target discovery, antibody development, clinical trials to commercial-scale manufacturing
.
It solves the major challenges of CAR-T cell therapy through independent research and development of new technologies and a product pipeline with global rights, such as improving safety, improving the efficacy of treatment of solid tumors and reducing treatment costs
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
It kills tumor cells and has the effect of treating corresponding hematological malignancies
.
Due to its great advantages in the treatment of hematological malignancies, CAR-T cell immunotherapy has become a hot research focus in recent years
.
From the perspective of the global CAR-T cell immunotherapy industry, China is catching up with the United States, especially since the adjustment stage in 2016, with the introduction of the guiding principles in 2017, the number of applications for CAR-T cell immunotherapy patents has greatly increased
.
At the same time, the approval of domestic new drug clinical research has accelerated.
Data shows that from 2020 to 2021, the number of INDs for cell therapy products in the United States will increase from 479 to 654, and the number of INDs for such products in China will increase from 264 to 420.
.
These data all prove the rise of domestic CAR-T cell immunotherapy
.
At present, in the field of CAR-T cell immunotherapy in China, there are not only a large number of companies that cooperate with large overseas pharmaceutical companies to introduce mature products and localize production, but also some local pharmaceutical companies that take the road of independent research and development, such as Shanghai Cell Group, Keji Biotechnology , Gracell Bio,
etc.
At the same time, in recent years, with the improvement of local innovation strength, some local pharmaceutical companies are also accelerating their international layout while facing the huge domestic cancer market demand
.
Recently, Keji Bio announced that the cGMP production plant built by the company's American company CARsgen Therapeutics Corporation in the Research Triangle Park (RTP) area of North Carolina, USA, has passed local inspections
.
Keji Pharmaceutical has obtained a compliance certificate issued by the Durham City and County Inspection Bureau and has started clinical production operations
.
It is reported that the factory is the first factory outside of China to start operation in the world of Keji Bio, which means that the company's global layout has reached a higher level
.
It is understood that the cGMP production plant of Keji Bio adopts an integrated project delivery method, which greatly shortens the construction period and improves cost-effectiveness..
The factory has a total construction area of about 3,300 square meters and can serve 700 patients per year.
It will greatly enhance the production capacity of Keji Pharmaceutical's autologous CAR-T cell products, and will support the company's clinical research and early commercialization in North America and Europe.
.
The project has received support from the Talent Development Investment Fund (JDIG) and other investment incentives from Durham County and the City of Durham, North Carolina, USA
.
In addition, in order to accelerate the clinical production of the RTP production plant, Keji Pharmaceutical's GMP production plant in Jinshan District, Shanghai, China will continue to conduct FDA-approved IND clinical studies in the United States for the company's two core product candidates, CT053 and CT041, to provide manufacturing Lentiviral vector material for CAR-T cell products
.
The large-scale production of viral vector material at its Jinshan production facility is expected to reduce the manufacturing cost of CAR-T cell products and improve patient accessibility
.
According to public information, Keji Bio is a biopharmaceutical company with operations in China and the United States, mainly focusing on innovative CAR-T cell therapy for the treatment of hematological malignancies and solid tumors
.
The company has built an integrated cell therapy platform with in-house capabilities ranging from target discovery, antibody development, clinical trials to commercial-scale manufacturing
.
It solves the major challenges of CAR-T cell therapy through independent research and development of new technologies and a product pipeline with global rights, such as improving safety, improving the efficacy of treatment of solid tumors and reducing treatment costs
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
