On November 21, 2023, the new drug clinical trial application (IND) for the cell therapy product "GKL-006 Injection" of Beijing Gene Qiming Biotechnology Co., Ltd. was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (acceptance number: CXSL2300567), and is intended for phase I/II clinical trials in the treatment of unresectable primary hepatocellular carcinoma. GKL-006 injection is one of the iNKT cell therapy products that have entered registered clinical research in China.

The Drug Safety Evaluation Research Center of Shandong Xinbo Pharmaceutical Research Co., Ltd. is responsible for the non clinical efficacy research, pharmacokinetic research, establishment and validation of relevant methodologies, and non clinical safety evaluation research of the product. The relevant research data provided support for the product to obtain clinical trial approval.

Primary liver cancer is one of the common malignant tumors in China, with significant unmet clinical needs.