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Recent popular reports from Yimaike ★ Heavy! Keji Pharmaceutical's CLDN18.
2 autologous CAR-T drug candidate was approved for clinical trials in Canada //--Keji Pharmaceutical (stock code: 2171.
HK) announced today that the FDA has granted its CAR-T cell candidate CT041 Regenerative Medicine Advanced Therapy (RMAT) designation targeting Claudin18.
2 (CLDN18.
2) for Treatment of CLDN18.
2 positive advanced gastric/esophagogastric junction adenocarcinoma (GC/GEJ)
.
According to publicly available data, CT041 is the world's first RMAT-certified solid tumor CAR-T product
.
RMAT qualification is a fast-track system established to accelerate the development and approval of innovative regenerative therapies when the United States revised the regenerative medicine provisions of the 21st Century Cures Act in December 2016
.
RMAT-qualified drugs are eligible for both the FDA's Breakthrough Therapy and Fast Track designations, resulting in intensive FDA guidance on effective drug development, including the ability to interact early with senior FDA management to discuss surrogate or intermediate endpoints, support acceleration Approval and potential approaches to meet post-approval requirements, priority review of potential biologics licensing applications, and other opportunities to expedite development and review
.
As early as October 2019, another core product candidate of Keji Pharmaceutical, CT053, a fully human CAR-T cell injection targeting B cell maturation antigen (BCMA), has been granted RMAT qualification by the FDA
.
It is reported that Keji Pharmaceutical is also the only company among China's CAR-T companies that has obtained RMAT certification
.
The best proof of the potential global First in Class by the blessing of global honors Since the FDA's new drug clinical trial was approved in May 2020, CT041 has made rapid progress and continued to receive honors
.
CT041 is the only CAR-T cell product candidate targeting CLDN18.
2 that has received IND/CTA approval from the U.
S.
FDA, China National Medical Products Administration (NMPA) and Health Canada, and is undergoing clinical trial research
.
In 2020 and 2021, CT041 was granted "orphan drug" designation by FDA and EMA and "PRIME" designation by EMA, respectively
.
CT041 has achieved numerous regulatory milestones around the world due to its impressive therapeutic effect and favorable safety profile in ongoing clinical trials
.
The latest data from the investigator-initiated trial presented at the 2021 ESMO Congress showed that among 18 gastric cancer patients who had failed at least 2 previous lines of therapy and received phase II recommended dose (RP2D) 2.
5×10⁸CT041 cell therapy, the objective response rate was 61.
1 %
.
Historical data show that for gastric cancer patients who have failed at least 2 lines of therapy, the objective response rate of chemotherapy drugs is about 4-8%, and the effective rate of anti-PD-1 mAb is about 11%
.
Therefore, compared with other treatment drugs for end-line gastric cancer patients, CT041 has achieved a significant improvement in the objective response rate and is generally well tolerated
.
The CLDN18.
2 target selected by Keji Pharmaceutical's CAR-T cell product CT041, as a pan-cancer target, is highly expressed in nearly 40-60% of gastric cancer patients, including pancreatic cancer (60% ), esophageal cancer (30-50%) and non-small cell lung cancer (25%) and other solid tumors are widely expressed
.
The emergence of CT041 allows us to see that CAR-T therapy is also promising in the field of solid tumors, providing another possibility for the treatment of solid tumors
.
Focusing on meeting the needs of patients and demonstrating a strong core of innovative R&D Continuously develop innovative proprietary technologies (CycloCAR, THANK-uCAR, etc.
) to improve the efficacy of CAR-T therapy in solid tumors
.
At present, Keji Pharmaceutical has 11 candidate products, all of which are independently developed and have global rights and interests, covering conventional, next-generation CAR-T technology and allogeneic therapy.
The forward-looking and leading advantages of research and development demonstrated in the field of CAR-T therapy for cancer
.
Through the self-developed fully human anti-phage display technology platform, Keji Pharmaceuticals has discovered fully human antibodies against BCMA, mesothelin and other targets, which target GPC3, Claudin18.
2, EGFR/EGFRvIII CAR-T cells The paper is also the first in the world with the same target
.
In 2021 alone, Keji Pharmaceutical has added nearly 100 new patents, and has applied for more than 300 patents worldwide, including 65 authorized patents
.
These are the most powerful evidences to demonstrate the strong R&D strength and innovation ability of Keji Pharmaceutical, and also the confidence of Keji Pharmaceutical as a model of local innovative pharmaceutical companies to participate in international competition and move towards globalization
.
Reference: https://bioinformant.
com/rmat/#list
2 autologous CAR-T drug candidate was approved for clinical trials in Canada //--Keji Pharmaceutical (stock code: 2171.
HK) announced today that the FDA has granted its CAR-T cell candidate CT041 Regenerative Medicine Advanced Therapy (RMAT) designation targeting Claudin18.
2 (CLDN18.
2) for Treatment of CLDN18.
2 positive advanced gastric/esophagogastric junction adenocarcinoma (GC/GEJ)
.
According to publicly available data, CT041 is the world's first RMAT-certified solid tumor CAR-T product
.
RMAT qualification is a fast-track system established to accelerate the development and approval of innovative regenerative therapies when the United States revised the regenerative medicine provisions of the 21st Century Cures Act in December 2016
.
RMAT-qualified drugs are eligible for both the FDA's Breakthrough Therapy and Fast Track designations, resulting in intensive FDA guidance on effective drug development, including the ability to interact early with senior FDA management to discuss surrogate or intermediate endpoints, support acceleration Approval and potential approaches to meet post-approval requirements, priority review of potential biologics licensing applications, and other opportunities to expedite development and review
.
As early as October 2019, another core product candidate of Keji Pharmaceutical, CT053, a fully human CAR-T cell injection targeting B cell maturation antigen (BCMA), has been granted RMAT qualification by the FDA
.
It is reported that Keji Pharmaceutical is also the only company among China's CAR-T companies that has obtained RMAT certification
.
The best proof of the potential global First in Class by the blessing of global honors Since the FDA's new drug clinical trial was approved in May 2020, CT041 has made rapid progress and continued to receive honors
.
CT041 is the only CAR-T cell product candidate targeting CLDN18.
2 that has received IND/CTA approval from the U.
S.
FDA, China National Medical Products Administration (NMPA) and Health Canada, and is undergoing clinical trial research
.
In 2020 and 2021, CT041 was granted "orphan drug" designation by FDA and EMA and "PRIME" designation by EMA, respectively
.
CT041 has achieved numerous regulatory milestones around the world due to its impressive therapeutic effect and favorable safety profile in ongoing clinical trials
.
The latest data from the investigator-initiated trial presented at the 2021 ESMO Congress showed that among 18 gastric cancer patients who had failed at least 2 previous lines of therapy and received phase II recommended dose (RP2D) 2.
5×10⁸CT041 cell therapy, the objective response rate was 61.
1 %
.
Historical data show that for gastric cancer patients who have failed at least 2 lines of therapy, the objective response rate of chemotherapy drugs is about 4-8%, and the effective rate of anti-PD-1 mAb is about 11%
.
Therefore, compared with other treatment drugs for end-line gastric cancer patients, CT041 has achieved a significant improvement in the objective response rate and is generally well tolerated
.
The CLDN18.
2 target selected by Keji Pharmaceutical's CAR-T cell product CT041, as a pan-cancer target, is highly expressed in nearly 40-60% of gastric cancer patients, including pancreatic cancer (60% ), esophageal cancer (30-50%) and non-small cell lung cancer (25%) and other solid tumors are widely expressed
.
The emergence of CT041 allows us to see that CAR-T therapy is also promising in the field of solid tumors, providing another possibility for the treatment of solid tumors
.
Focusing on meeting the needs of patients and demonstrating a strong core of innovative R&D Continuously develop innovative proprietary technologies (CycloCAR, THANK-uCAR, etc.
) to improve the efficacy of CAR-T therapy in solid tumors
.
At present, Keji Pharmaceutical has 11 candidate products, all of which are independently developed and have global rights and interests, covering conventional, next-generation CAR-T technology and allogeneic therapy.
The forward-looking and leading advantages of research and development demonstrated in the field of CAR-T therapy for cancer
.
Through the self-developed fully human anti-phage display technology platform, Keji Pharmaceuticals has discovered fully human antibodies against BCMA, mesothelin and other targets, which target GPC3, Claudin18.
2, EGFR/EGFRvIII CAR-T cells The paper is also the first in the world with the same target
.
In 2021 alone, Keji Pharmaceutical has added nearly 100 new patents, and has applied for more than 300 patents worldwide, including 65 authorized patents
.
These are the most powerful evidences to demonstrate the strong R&D strength and innovation ability of Keji Pharmaceutical, and also the confidence of Keji Pharmaceutical as a model of local innovative pharmaceutical companies to participate in international competition and move towards globalization
.
Reference: https://bioinformant.
com/rmat/#list
