Berson Gianco's CAR-T clinical application was accepted

January 03, 2018 Source: Yaodutoutou

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On January 2, 2018, Anhui Anke Bioengineering (Group) Co., Ltd. participated in the company Berson Gianke Cell Technology Co., Ltd. received the "Notice of Acceptance" from the State Administration of Food and Drug Administration Administrative License Document, submitted by Boshi Gianke The application for clinical trial of CAR-T therapy "targeting CD19 autologous chimeric antigen receptor T cell infusion" was accepted by the State Food and Drug Administration on December 28, 2017, and the acceptance number is: CXSL1700216.

Chimeric antigen receptor T cells (abbreviation: CAR-T) is a novel immunotherapy that represents the latest development trend in cancer therapy. This technology is a single-chain antibody gene that targets tumor antigens and a signal molecule that activates T cell activity and promotes T cell survival. It is expressed on the patient's peripheral T lymphocytes through a gene modification strategy, thereby treating the patient's T lymphocytes. The cells are transformed into drugs that specifically kill tumors. In international and domestic related clinical trials, it has shown great lethality and clinical efficacy for specific tumor types. The CAR-T drug accepted by Berson Gianco is a therapy against B cell acute lymphoblastic leukemia (B-ALL) targeting CD19 molecule.

Boss Gianke is not only committed to the development of cellular immunotherapy products for the treatment of hematological tumor B-ALL, but also actively carries out CAR for T-cell acute lymphoblastic leukemia (T-ALL) and solid tumors such as lung cancer and pancreatic cancer. -T product development. Berson Gianco has established a 2,000-square-meter CAR-T cell production workshop and a complete quality control system and quality control facilities and equipment that meet the GMP requirements, which can fully meet the clinical test requirements of CAR-T cell products.

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