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On November 15, 2021, Keji Pharmaceuticals official website announced that its self-developed CT041 (an autologous CAR-T candidate for CLDN 18.
2) has been granted priority medicine (PRIME) qualification by the European Medicines Agency (EMA) , Used to treat gastric cancer/gastric junction cancer
.
As of the date of this announcement, CT041 is the world’s only CAR-T cell immunotherapy method that targets CLDN 18.
2 and has been approved by the US FDA and the National Food and Drug Administration and is undergoing clinical trials.
It is the first to obtain CAR-T products for solid tumors with priority drug qualifications
.
▲ Keji Pharmaceutical pipline, source: Keji Pharmaceutical official website
CT041 is a potential first-in-class product of its kind in the world that targets CLDN18.
2 autologous CAR-T candidate products.
It has been developed to treat CLDN18.
2-positive solid tumors, mainly for the treatment of gastric cancer/gastroesophageal junction cancer and pancreatic cancer
.
CT041 has shown promising therapeutic effects and good safety in ongoing clinical trials
In addition to the trials initiated by researchers in China, Keji Pharmaceuticals has also initiated a phase Ib/II clinical trial for advanced (unresectable or metastatic) gastric cancer/gastric junction cancer and pancreatic cancer in China, and A phase Ib clinical trial for advanced (unresectable or metastatic) gastric or pancreatic cancer was initiated in the United States
.
CT041 was approved by the US FDA as an "orphan drug" in 2020 for the treatment of gastric cancer/gastric esophageal junction cancer, and in 2021, it was granted an "orphan drug product" by the EMA for the treatment of gastric cancer
Claudin 18.
2 is considered to be a very promising target for the next generation of gastric cancer after HER2.
At present, there is no drug targeting Claudin 18.
2 on the market in the world
.
Claudin 18.
2 belongs to the Claudins protein family.
Claudin is an important molecule that constitutes tight junctions of cells.
Tight junctions determine the permeability of epithelial cells and also play a role in blocking the diffusion of cell membrane surface proteins and lipids
.
Claudin 18.
The activation and expression of Claudin 18.
2 depends on the binding of the transcription factor cyclic adenylate response element binding protein to the unmethylated protein binding site of its gene
.
Due to the high specificity of Claudin 18.
Domestically, there are a large number of companies developing Claudin 18.
▲Incomplete statistics, as of August 2021, Meibai Medical Health has compiled
