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Keji Pharmaceutical (stock code: 2171.
HK), announced today that its self-developed CAR-T product CT041 has been granted "Regenerative Medicine Advanced Therapy" (RMAT) qualification by the U.
S.
Food and Drug Administration (FDA) for the treatment of Claudin18.
2 (CLDN18.
2) positive advanced gastric/esophagogastric junction adenocarcinoma (GC/GEJ)
.
According to publicly available data, CT041 is the world's first RMAT-qualified solid tumor CAR-T product*
CT041's RMAT qualification this time means that it can enjoy multiple support policies such as FDA's "Breakthrough Therapy" and "Fast Track" at the same time, including closer communication with the FDA, and can also obtain Eligibility for accelerated approval; accreditation based on CT041's promising therapeutic efficacy and favorable safety profile in ongoing clinical trials
.
CT041 is a potential first-of-its-kind CAR-T candidate product independently developed by Keji Pharmaceutical, which is mainly used for the treatment of gastric cancer/esophagogastric junction adenocarcinoma and pancreatic cancer
.
As of the announcement date, CT041 is the only CLDN18.
List of past important regulatory milestones in CT041:
In 2020, CT041 was granted "orphan drug" status by the US FDA for the treatment of gastric cancer/esophagogastric junction adenocarcinoma;
In 2021, CT041 was granted "orphan drug product" status by the European Medicines Agency (EMA) for the treatment of advanced gastric cancer;
In 2021, CT041 was granted a "Priority Medicine" (PRIME) designation by the EMA for the treatment of advanced gastric cancer
.
CT041 is the world's first solid tumor CAR-T product selected for the PRIME program
In October 2019, CT053, another BCMA CAR-T product independently developed by Keji Pharmaceuticals, was also granted RMAT qualification by the US FDA for the treatment of relapsed/refractory multiple myeloma.
CT041 is the successor to CT053.
The industry's second RMAT-qualified product
.
As of the announcement date, among all CAR-T companies in China, Keji Pharmaceutical is the only one whose products have obtained the RMAT qualification, and the company's R&D strength has been fully demonstrated
Keji Pharmaceutical has 11 candidate products, all of which are independently developed and have global rights and interests, and have obtained 8 clinical trial licenses (IND) for CAR-T products, ranking first among all CAR-T companies in China
.
As of December 31, 2021, the company has applied for more than 300 patents worldwide, including 65 authorized patents
Dr.
Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer and Chief Scientific Officer of Keji Pharmaceutical, said:
The RMAT qualification granted by the FDA for CT041 this time has once again proved the excellent performance of this product, indicating that it has great potential to solve unmet medical needs.
RMAT is for accelerated product development and Biologics License Application (BLA) review All are very important to help patients get this advanced therapy as soon as possible
.
We believe that the RMAT, PRIME, and orphan drug designations obtained by CT041 will enable us to work more closely with global regulatory agencies to bring CT041 to market as soon as possible and benefit patients around the world
About CT041
About CT041The latest data from the investigator-initiated trial of CT041 presented at the 2021 ESMO Congress showed that in 18 gastric cancer patients who had failed at least 2 previous lines of therapy and received phase II recommended dose (RP2D) of 2.
5 × 10⁸ CT041 cells, the objective response rate was up to 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% to 8%, and the effective rate of anti-PD-1 monoclonal antibody is about 11%
In addition to the investigator-initiated trial in China, Keji Pharmaceuticals has initiated a Phase Ib/II clinical trial in China for advanced gastric/gastroesophageal junction and pancreatic cancer, and a trial in North America for Phase 1b clinical trial in advanced gastric or pancreatic cancer
.
Keji Pharmaceutical also plans to initiate a pivotal Phase 2 clinical trial in North America in 2022
About Regenerative Medicine Advanced Therapy RMAT
About Regenerative Medicine Advanced Therapy RMATRMAT designation is granted to cell therapies, tissue engineered therapeutic products, human cell and tissue products, or any combination product using related therapies or products for the purpose of treating, modulating, reversing or curing a serious or life-threatening disease or condition
.
To qualify for RMAT, an investigational drug must have preliminary clinical evidence that the drug has the potential to address an unmet medical need for the disease or condition
.
RMAT designation confers "fast track" review and "breakthrough therapy" benefits, including more frequent meetings with the FDA to discuss development plans for product candidates, as well as rolling review and priority review designation
.
References
What Is An RMAT? List of RMAT Designations.
Retrieved January 10, 2022, from https://bioinformant.
com/rmat/#list
