Cancer-Free for 5 Years! First Patient Treated with BonYak Bio's Non-Viral PD1-Targeted CAR-T Achieves Durable Complete Remission

On September 17, 2025, BRL Medicine Inc., a Shanghai-based biotechnology company focusing on gene and cell therapy (hereinafter referred to as "BRL Medicine"), announced that its self-developedThe first malignant lymphoma patient treated with BRL Medicine's global new-generation targeted CD19 non-viral定点integration PD1-CAR-T product (pipeline code: BRL-201) has achieved cancer-free survival for over 5 years, continuously validating the efficacy of this therapy.Outstanding Long-termEfficacy and SafetyPatient Mr. Sun (pseudonym) has completed the 5-year follow-up. The latest hematological tests and CT scan results show no significant abnormalities in all indicators. Mr. Sun remains in a state of complete remission (CR) after BRL-201 treatment. Currently, Mr. Sun is in good health, and the adverse events that occurred after CAR-T treatment have long been resolved without any new adverse events occurring.

Mr. Sun's Recent Photo: Over 5 Years Cancer-Free After BRL-201 PD1-CAR-T Cell Therapy

It is worth mentioning that,BRL-201 is the world's first non-viral targeted integration CAR-T cell therapy successfully applied in clinical tumor treatment., and this therapy breaks through the limitations of using viruses and random integration in traditional CAR-T cell preparation, also relieving the immune suppression of CAR-T cells by tumors. Due to its unique global leadership, relevant research achievements have been successively published in top journals. Nature(2022) andeClinicalMedicine(2023), and was successively awarded "Top Ten Research Advances in Hematology in China, 2022" and "Major Medical Progress in China, 2022".Such prestigious honors.

Mr. Sun, 52 years old, currently resides in Yangjiang City, Guangdong Province. AsThe world's first patient to receive BRL Medicine's non-viral targeted integration PD1-CAR-T innovative therapy "BRL-201" has now successfully crossed the five-year cancer-free survival milestone.Looking back on the past five years, Mr. Sun感慨道: "Before the treatment, I could hardly walk, let alone exercise or work. Now, I play badminton at least three times a week and can easily handle my job, truly returning to a healthy and normal life." He also特别提到 that since receiving CAR-T cell therapy, his son was able to安心地 complete the college entrance exam and has successfully been admitted to university. The reunion and everyday happiness of the family have become more complete because of his recovery.

Looking Back on Mr. Sun's Cancer-Fighting Journey: Undoubtedly Arduous and Full of Challenges

Until 2020, Mr. Sun regained hope for life thanks to CAR-T therapy. After overcoming numerous challenges, he contacted Professor He Huang from the First Affiliated Hospital of Zhejiang University School of Medicine and was fortunate to join the clinical trial research on "PD1-Knockout Non-Viral Site-Specific Integration CD19-CART Cell Therapy for Relapsed or Refractory Non-Hodgkin Lymphoma," conducted by Professor Huang in collaboration with BRL Medicine. As the first patient in this BRL-201 clinical trial, Mr. Sun officially received cell infusion. On June 9, 2020, Mr. Sun was discharged after recovery. To date, clinical observations show complete remission (CR), and he has been cancer-free for over five years.

In this regard, Mr. Sun's wife also expressed: "His recovery is the greatest blessing for our entire family. The atmosphere at home had been very gloomy before, but now he can finally play sports and spend time with the children, bringing vitality back to our family life. The children also feel reassured and fulfilled because of their father’s companionship. We sincerely thank all the medical teams for their dedication and the power of science for giving us hope to regain a joyful life."

Seeing patients regain their health and tumors continuously alleviated. AsThe Principal Investigator (PI) of this clinical trial, Professor Huang He"It has been over 5 years since the patient received BRL-201 cell therapy. Recent blood tests, biochemical indicators, and CT imaging results all show no abnormalities, with the patient’s condition remaining stable. It can be said that no long-term adverse events have occurred following BRL-201 CAR-T treatment, and the tumor has remained in complete remission. The 5-year follow-up data further confirms that this product is not only safe and effective but also provides long-term survival benefits for patients."

In addition, in this clinical study of BRL-201 CAR-T cell therapy for refractory and relapsed lymphoma, it demonstratedThe best clinical results of high remission rates and low toxic side effects in refractory tumors treated with CAR-T globally so far, with outstanding research findings published in a top journal in 2022.Nature Up.In this study, a total of 21 patients received BRL-201 CAR-T cell therapy. Clinical results showed that the objective response rate (ORR) was as high as 100%, and the complete response rate (CR) reached 85.7%. According to the latest official data, the median overall survival (mOS) exceeded 40 months, and the median progression-free survival (mPFS) reached over 20 months. Moreover, no grade 2 or higher cytokine release syndrome or neurotoxicity was observed in any patient, demonstrating the excellent clinical safety and efficacy of the BRL-201 product.

Compared with existing CAR-T therapies, BRL-201 from BRL Medicine adopts non-viral site-specific integration CAR-T technology, offering advantages such as low cost and rapid preparation (as short as 3 days), significantly improving patient accessibility and treatment timeliness. Currently,BRL Medicine Focuses on Relapsed/Refractory B-cell Non-Hodgkin Lymphoma Based on the Non-Viral Targeted Integration PD1-CAR-T Technology（R/R B-NHL）Moderate or Severe Refractory Systemic Lupus Erythematosus (SLE) has been approved for 2 Chinese INDs and has officially entered the registration clinical trial stage.

Professor Mingyao Liu, Founder and Chief Scientist of BRL Medicine, statedBRL Medicine will continue to focus on patients, and work with clinical experts to fully promote the research成果转化落地 of a new generation of globally pioneering non-viral targeted integration PD1-CAR-T, committing to bring patients a new generation of PD1-CAR-T cell drug that offers significant advantages in safety, efficacy, and cost.

AboutBRL Medicine

BRL Medicine Inc. is committed to becoming a global leading cell and gene pharmaceutical company in the new era of commercial civilization. With the mission of "leading innovation with gene editing technology, developing breakthrough therapies, and benefiting all humanity," BRL Medicine, relying on its self-developed center and the "Shanghai Gene Editing and Cell Therapy Research Center" co-built with universities, has generated more than 100 patent achievements so far. Currently, 19 projects are undergoing clinical trials in more than 20 well-known hospitals, with 5 projects approved for IND, officially entering the registered clinical trial stage, and several other projects entering the IND application stage. Among them, gene editing therapy for β-thalassemia, non-viral targeted integration PD1-CAR-T, and UCAR-T projects have achieved excellent clinical results, demonstrating global leadership.Nature、Cell、Nature Medicine、Nature biotechnology...and published multiple academic papers in well-known academic journals. BRL Medicine has established five proprietary technology platforms: a gene-editing technology innovation platform, a hematopoietic stem cell platform, a non-viral site-specific integration CAR-T platform, a universal cell platform, and an enhanced T-cell platform. With a 7000-square-meter GMP pilot production base and a nearly 100-person operations team, BRL Medicine effectively ensures that innovative research achievements can be rapidly transformed and applied. By continuously driving the rapid updating and iteration of its R&D products based on patient needs and clinical feedback, BRL Medicine upholds an attitude of openness, sharing, and win-win cooperation. Together with global innovative biopharmaceutical ecosystem companies, it accelerates the transformation and implementation of innovative drugs, benefiting patients worldwide who suffer from genetic diseases, malignant tumors, and autoimmune disorders!

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