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Recently, according to the official website of the National Medical Products Administration, the IND application for another indication of "GKL-006 Injection," a cell therapy product by Beijing Gene Key Life Technology Co., Ltd. ("Gene Key"), for unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma has been accepted by the CDE.On November 21, 2023, the Investigational New Drug (IND) application for "GKL-006 Injection," a cell therapy product developed by Beijing Gene Key Life Technology Co., Ltd., received approval from the Center for Drug Evaluation (CDE). This greenlights the upcoming Phase I/II clinical study to treat unresectable primary hepatocellular carcinoma. As China’s first iNKT cell therapy product to enter the registrational clinical stage, "GKL-006 Injection" is paving new directions in the exploration of cancer immunotherapy in China.Beijing Gene Key Life Technology Co., Ltd was established in 2015. It is the world's first leading company to develop a series of iNKT cell pipeline products; it has a biomedical and immunology basic research team, an iNKT cell basic research platform, a clinical research platform, and a large-scale expanded cell culture system.References:
CDE
Company Official Website
