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Shanghai, November 15, 2021/PRNewswire/ - Keji Pharmaceutical (stock code: 2171.
HK) announced today that the company’s self-developed CT041, an autologous CAR-T candidate for CLDN 18.
2, has It was granted priority medicine (PRIME) qualification by the European Medicines Agency (EMA) for the treatment of gastric cancer/gastroesophageal junction cancer
.
CT041 is the world's first solid tumor CAR-T product selected for the PRIME program.
CT041 is a potential first-in-class CAR-T candidate product independently developed by Keji Pharmaceutical.
Its main indications are gastric cancer/gastroesophageal junction cancer and pancreatic cancer
.
As of the announcement date, CT041 is the world's only CAR-T cell immunotherapy method that targets CLDN 18.
Previously, the BCMA CAR-T candidate product CT053 of Keji Pharmaceuticals was included in the PRIME plan in 2019.
So far, Keji Pharmaceuticals has become the only company in the world that has two CAR-T products included in the PRIME plan
.
Dr.
Li Zonghai, Founder, Chairman of the Board, CEO, and Chief Scientific Officer of Keji Pharmaceutical said: "The inclusion of Keji Pharmaceutical’s CT041 in the EMA PRIME program is an important milestone for the continued development and commercialization of this product.
CT041 is promising.
In the future, it will become the backbone therapy for gastric cancer and pancreatic cancer, benefiting patients around the world
About CT041
CT041 is a potential first-in-class autologous CAR-T candidate product targeting CLDN18.
2 in the world.
It is being developed for clinical treatment of CLDN18.
2-positive solid tumors such as gastric cancer/gastroesophageal junction cancer and pancreatic cancer
.
In addition to clinical 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/gastroesophageal junction cancer, and in 2021, it was approved by the EMA as an "orphan drug product" for the treatment of gastric cancer
About PRIME
PRIME is a program launched by EMA to support the development of medicines aimed at solving unmet medical needs
.
Through PRIME, EMA proactively provides early support to medical researchers to generate as reliable data as possible on medical benefits and risks and to ensure accelerated review of medical applications
The PRIME program helps patients benefit from therapies that may greatly improve their quality of life as early as possible
.
To be recognized by PRIME, a medicine must show its potential to provide major treatment advantages over existing treatments or to benefit patients without treatment options
About Keji Pharmaceutical
Keji Pharmaceutical (stock code: 2171.
HK) is a biopharmaceutical company with operations in China and the United States, focusing on innovative CAR-T cell therapies for the treatment of hematological malignancies and solid tumors
.
We have established a comprehensive cell therapy platform whose internal capabilities cover everything from target discovery, antibody development, clinical trials to commercial-scale production
