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.

In the IIT clinical study of BRL-201 in the treatment of relapsed and refractory non-Hodgkin lymphoma in the cooperation between BRL Medicine and the First Affiliated Hospital of Zhejiang University School of Medicine, no CAR-T-related neurotoxicity and cytokine storm above grade 2 were observed in 8 patients who received the treatment, which proved that BRL-201 has excellent clinical safety. According to the test results, CAR-T cells can expand rapidly and persist for a long period of time in patients after infusing them back into the body, and 87.5% of patients after treatment have achieved complete remission (CR), and all patients respond to treatment, and the objective response rate (ORR) is 100%. So far, patients who have received this CAR-T therapy have had a maximum cancer-free survival of more than 2 years and are still in complete disease remission. Whether for the treatment of patients with high PD-L1 expressing tumors, or under the condition of low CAR-T cell reinfusion dose and positive rate, BRL-201 has shown good efficacy, proving its strong tumor killing ability. The research results were officially published in the top international academic journal Nature on August 31, 2022,which is also the first CAR-T research result published in the top journal Nature in China .