The self-developed product CT041 of Keji Pharmaceutical was awarded the "Advanced Therapy of Regenerative Medicine" by the FDA

Keji Pharmaceutical (stock code: 2171.
HK), an innovative CAR-T cell therapy company mainly focusing on the treatment of hematological malignancies and solid tumors, recently announced that its self-developed CAR-T product CT041 was approved by the US Food and Drug Administration The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation 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*
.
So far, Keji Pharmaceutical has also become the only Chinese CAR-T company that has obtained RMAT qualifications for both of its core candidate products
.
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 is 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.
2-targeting CAR-T cell candidate product in the world that has obtained IND/CTA approval from the U.
S.
FDA, the China National Medical Products Administration and Health Canada, and is undergoing clinical trial research
.
List of important past regulatory milestones of 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" status by the European Medicines Agency (EMA) Product" designation for the treatment of advanced gastric cancer; CT041 was granted "Priority Medicine" (PRIME) designation by the EMA in 2021 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 Pharmaceutical, was also granted RMAT qualification by the US FDA for the treatment of relapsed/refractory multiple myeloma.
CT041 is Keji Pharmaceutical after 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.
Li Zonghai, founder, chairman of the board, CEO and chief scientific officer of Keji Pharmaceutical, said: CT041's RMAT qualification granted by FDA this time has once again proved the excellent performance of this product, indicating that it has great potential to solve the problem of unresolved problems.
To meet the medical needs, RMAT is very important for accelerating product development and review of Biologics License Application (BLA), helping patients to obtain this advanced therapy as soon as possible.
We believe that the RMAT, PRIME and orphan drug qualifications obtained by CT041 will enable us to We can work more closely with global regulatory agencies to promote CT041 to the market as soon as possible and benefit patients around the world
.
The latest data from the investigator-initiated trial of CT041 presented at ESMO 2021 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 × 10? CT041 cells, 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% to 8%, and the effective rate of anti-PD-1 mAb is about 11%..
Therefore, CT041 has achieved a significant improvement in the objective response rate compared with other therapeutic drugs for end-line gastric cancer patients
.
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 A Phase 1b clinical trial for advanced gastric or pancreatic cancer Keji Pharmaceuticals also plans to initiate a pivotal Phase 2 clinical trial in North America in 2022
.
Regarding Regenerative Medicine Advanced Therapies (RMAT) RMAT qualifications are granted to cell therapies, tissue engineered therapeutic products, human cell and tissue products, or any combination product using related therapies or products, and the purpose of which is to treat, modulate, reverse or cure serious or threatened To qualify for RMAT, an investigational drug for a disease or condition of life 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
.