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On March 23, 2022, Keji Pharmaceutical announced that CT041, the company's self-developed CAR-T cell candidate product, completed the first patient enrollment in China's confirmatory phase II clinical trial at Peking University Cancer Hospital.
As of the publication date, CT041 is the world's first and only CAR-T cell product candidate for the treatment of solid tumors that has entered a confirmatory phase II clinical trial; it is also the world's only approved CAR-T cell product from the US FDA, the China National Medical Products Administration and Health Canada.
CT041 List of important regulatory milestones
CT041 List of important regulatory milestones2020
CT041 has been granted "orphan drug" designation by the US FDA for the treatment of gastric cancer/esophagogastric junction adenocarcinoma
2021
CT041 was granted "Orphan Drug Product" status by the European Medicines Agency (EMA) for the treatment of advanced gastric cancer;
CT041 was granted "Priority Medicine" (PRIME) designation by the EMA for the treatment of advanced gastric cancer
2022
CT041 was granted "Regenerative Medicine Advanced Therapy" (RMAT) designation by the US FDA for the treatment of CLDN18.
Dr.
Founder, Chairman of the Board, Chief Executive Officer, Chief Scientific Officer of Keji Pharmaceutical
Dr.
About CT041
About CT041CT041 is a potential first-in-class autologous CAR-T cell product candidate targeting CLDN18.
Keji Pharmaceuticals conducted an investigator-initiated trial in China, a Phase Ib clinical trial in advanced gastric/EGJ adenocarcinoma and pancreatic cancer, a confirmatory study in advanced gastric/EGJ adenocarcinoma A Phase II clinical trial, and a Phase 1b clinical trial for advanced gastric or pancreatic cancer has been initiated in North America, and a pivotal Phase 2 clinical trial is also planned to be initiated in North America in 2022
About CLDN18.
About CLDN18.
Keji Pharmaceutical is the first in the world to successfully identify, validate and report that CLDN18.
About Keji Pharmaceutical
About Keji PharmaceuticalKeji Pharmaceutical (stock code: 2171.
