September 17, 2025 – BRL Medicine Inc. (referred to as “BRL Medicine”), a company focused on gene and cell therapy, announced that the first patient with malignant lymphoma treated with its independently developed next-generation non-viral PD1-integrated anti-CD19 CAR-T product (pipeline code: BRL-201) has achieved over 5 years of cancer-free survival, consistently demonstrating the therapy’s exceptional long-term efficacy and safety. The patient, Mr. Sun (pseudonym), has completed his 5-year follow-up. Recent hematological and CT examinations showed no significant abnormalities, and he remains in complete remission (CR) after BRL-201 treatment. Mr. Sun is currently in good health, with all adverse events occurring post-CAR-T therapy having resolved and no new adverse events reported.

A recent photo of Mr. Sun. He has been treated with brl-201 pd1-car-t cells and has survived without cancer for more than 5 years

Notably, BRL-201 is the world’s first non-viral PD1-integrated CAR-T cell therapy successfully applied in clinical cancer treatment. This therapy overcomes the limitations of viral vectors and random integration in conventional CAR-T cell preparation, while also relieving tumor-mediated immunosuppression of CAR-T cells. Due to its global pioneering nature, related research results have been published in top-tier journals including Nature (2022) and eClinicalMedicine (2023), and have been honored with prestigious awards such as “China’s Top 10 Advances in Hematology Research in 2022” and “China’s Significant Medical Advances of 2022”.

Five-Year Follow-Up Confirms Robust and Sustained Efficacy of BRL-201

In this clinical study of BRL-201 CAR-T cell therapy for relapsed/refractory lymphoma, the best clinical outcomes to date globally in terms of high response rates and low toxicity in CAR-T treatment of refractory tumors were demonstrated. The outstanding results were published in the top-tier journal Nature in 2022. A total of 21 patients received BRL-201 CAR-T cell therapy. Clinical results showed an objective response rate (ORR) of 100% and a complete remission (CR) rate of 85.7%. According to the latest official data, the median overall survival (mOS) exceeded 40 months, and the median progression-free survival (mPFS) exceeded 20 months. Moreover, no patient experienced Grade 2 or higher cytokine release syndrome or neurotoxicity, confirming the excellent clinical safety and efficacy of the BRL-201 product.

In August 2022, the journal Nature published an article

Compared to existing CAR-T therapies, BRL Medicine’s BRL-201 utilizes non-viral PD1-integrated CAR-T technology, offering advantages such as lower cost and faster preparation (as short as 3 days), significantly improving patient accessibility and treatment timeliness. Currently, based on this non-viral PD1-integrated CAR-T technology, BRL Medicine has obtained two IND approvals in China for relapsed/refractory B-cell non-Hodgkin’s lymphoma (R/R B-NHL) and moderate to severe refractory systemic lupus erythematosus (SLE), officially entering the registered clinical trial stage.

Professor Mingyao Liu, Founder and Chief Scientist of BRL Medicine, stated that the company will continue to focus on patients and work with clinical experts to fully advance the translation and implementation of this groundbreaking non-viral PD1-integrated CAR-T therapy, striving to deliver a next-generation PD1-CAR-T cell drug with significant advantages in safety, efficacy, and cost.