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  • Company News

    BRL Medicine’s world's first non-viral PD1 - CAR-T product " BRL-201 " obtained IND approval from CDE

    2022-12-14

    On December 14, 2022, BRL Medicine Inc. (hereinafter referred to as " BRL Medicine?") declare its clinical trial application (IND) entitled " Non-Viral PD1 Specific Integrated Anti-CD19?Chimeric Antigen Receptor T Cells Injection" (pipeline code: BRL-201), which was developed by utilizing the Quikin CART? platform with independent intellectual property rights, has been officially approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China!



    BRL-201: Relying on the new generation of Quikin CART? technology , it is safe and effective

    BRL-201 is an?anti-CD19 CAR-T product developed by BRL Medicine?utilizing?the Quikin CART? platform for?relapsed/refractory B-cell non-Hodgkin?lymphoma (R/R B-NHL).?It is worth mentioning that this is the world's first non-viral PD1 ?anti-CD19?CAR-T product, which can obtain genome-specific integration of CAR-T cell products in one step without using?viral vectors, which has the advantages of ?low cost , short preparation time, simple process, high safety and efficacy. The preparation of traditional CAR-T products is mainly realized by viral vectors, which will bring several prominent problems: complicated?production process, high cost, long preparation period, and potential tumorigenic risk. In contrast?, ?BRL-201 can effectively solve several major problems of using viral vectors, showing great advantages and potential. Site-specific integration allows each CAR sequence to be precisely inserted into a specific site of the genome, avoiding the risk of tumorigenesis caused by random insertion, and maximizing?the safety and efficacy?of CAR-T products. The one-step preparation can?achieve the continuous expression of CAR and the regulation of endogenous genes in T cells at the same time, which greatly shortens the preparation time of the entire CAR-T product, and the use of non-viral production technology also has potential cost advantages, which can benefit more patients.