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.