On November 21, 2023, Beijing Yiming Biotechnology Co., Ltd.'s cell therapy product "GKL-006 injection liquid" new drug clinical trial (IND) applied for obtaining the Drug Review Center (CDE) permit (acceptance number: CXSL2300567), which is about to open Phase I/II clinical research of irrevised primary liver cell carcinoma. "GKL-006 injection", as the first INKT cell therapy product in my country to enter the registered clinical stage, is developing a new direction for the exploration of tumor immunotherapy in my country.

The Drug Safety Evaluation Research Center of Shandong Xinbo Drug Research Co., Ltd. has undertaken the pre-clinical effectiveness research, pharmacokinetics research, method establishment and verification, and comprehensive safety evaluation research of cell therapy products "GKL-006 injection solution". The display of this product has good security and effectiveness to help them obtain clinical trial permits.

Primary liver cancer is currently the fourth common malignant tumor in my country and the cause of death of the second tumor. According to statistics from the National Cancer Center (NCCR), new cases and deaths of liver cancer in 2022 reached 442,000 and 390,000, respectively. The prognosis of patients with liver cancer in my country is poor. Due to the hidden disease of liver cancer, the proportion of advanced liver cancer has a high proportion of liver cancer. It has lost the opportunity of surgical treatment, and the recurrence rate of liver cancer has a high recurrence rate.

GKL-006 injection is an INKT cell therapy. In the field of liver cancer, INKT cells exert a multi-anti-tumor mechanism. Inkt cells can indirectly kill MHC -negative or positive tumor cells by reverse NK cells and CD8+T lymphocyte activity in the micro -ring in the micro -ring in the micro -ring in the micro -ring, enhance the activity of anti -tumor in the body.

Part of the content is quoted from: https://mp.weixin.qq.com/s/8zsg26lojzmfcw5pjfea6g

Shandong Xinbo Pharmaceutical Research Co., Ltd. has rich experience in preclinical safety evaluation of biological products, and has helped more than 30 fully innovative biological products obtain clinical approvals. At the same time, Shandong Xinbo Pharmaceutical Research Co., Ltd. will continue to explore and accumulate relevant experimental technologies, improve service capabilities, in order to provide high-quality and efficient services to more customers around the world, and help new drugs be approved quickly.

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