Strategic Collaboration Between Tongli Haiyuan Biotech and BangYao Biotech to Advance a New Era of CAR-T Therapy
BRL Medicine
Cell and Gene Therapy Drug Developer
November 20, 2025
eMedClub News
Join Hands to Open a New Chapter in the Treatment of Autoimmune Diseases
Beijing Tongli Haiyuan Biotechnology Co., Ltd.(The following"TLHY Bio""Thing")Shanghai BRL Medicine Inc.(hereinafter referred to as "BRL Medicine")Officially announced, the two parties signed a strategic cooperation agreement on November 18, 2025. The collaboration will focus on BRL Medicine's globally leading non-viral PD1 targeted integration CAR-T product.（BRL-201）Deepen cooperation to jointly accelerate the therapy for relapsed or refractory B-cell non-Hodgkin lymphoma（R/R B-NHL）Clinical translation and commercialization progress in the field, providing more accessible and safer cell therapy solutions for cancer patients.
CombinedBackground
Breaking Through Traditional CAR-T Bottlenecks, Non-Viral Technology Leads Industry Transformation
As an innovative company in China's biopharmaceutical field, Tongli Haiyuan Biotechnology has long been committed to the research and development and industrialization support of cell therapy technologies, with mature process development and production platforms. The non-viral targeted integration CAR-T platform independently developed by BRL Medicine（Quikin CART®）It is the world's first CAR-T technology capable of precise genome editing without the need for a viral vector. Its core product, BRL-201, uses CRISPR/Cas9 gene editing technology to integrate the CD19-targeting CAR sequence into the PD1 site, overcoming industry challenges such as high production costs, long manufacturing cycles, and potential safety risks associated with traditional viral vector CAR-T therapies.
01
More Accessible
Non-viral processes significantly reduce production costs, benefiting more patients;
02
Faster
Preparation completed in as short as 3 days, suitable for patients with rapidly progressing tumors;
03
Safer
Targeted integration avoids the risk of tumorigenesis caused by random insertion; clinical data shows no cytokine storms or neurotoxicity above grade 2.
04
More Effective
In IIT studies, the objective response rate of patients（ORR）Up to 100%, Complete Remission Rate（CR）Reaching 87.5%, Progression-Free Survival（mPFS）Increased to 20.8 months, with mOS reaching over 45 months, significantly outperforming traditional viral CAR-T products.
The clinical results of BRL Medicine's BRL-201 were published in *Nature* in 2022 and were recognized as one of the "Top Ten Research Advances in Hematology in China." This collaboration will leverage the strengths of Tongli Haiyuan in upstream raw materials for cell therapy, process development, and large-scale production to further optimize the industrial chain layout of BRL-201 and accelerate its industrial implementation.
Highlights of Cooperation
Resource Complementarity to Build a Full-Chain Non-Viral CAR-T Ecosystem
Technical Synergy: Tongli Haiyuan will provide high-quality CGT research and production tools, including GMP-grade cell sorting magnetic beads, recombinant proteins, and serum-free cell culture media, to help BRL-201 achieve stable and scalable production;
Clinical Progress: The two parties jointly collaborate with top clinical research centers in China.(such as the First Affiliated Hospital of Zhejiang University, the Hematology Hospital of Chinese Academy of Medical Sciences, etc.), accelerate the multi-center Phase I/II registered clinical trials to promote the early market launch of the product;
Global Layout: By cooperating to打通从研发、生产到商业化的全链条，为后续拓展海外市场奠定基础。
Future Outlook
Empower the Cell Therapy Industry Chain, Co-create New Industry Benchmarks
As a leading enterprise in China for core raw materials and technical services in the upstream of cell therapy, Tongli Haiyuan Biotechnology has always been committed to providing one-stop solutions for innovative pharmaceutical companies. This strategic cooperation with BRL Medicine not only assists BRL Medicine in achieving the localization of key materials to ensure supply chain security but also deepens the collaborative innovation model of "industry-academia-research-medicine." In the future, both parties will continue to explore the application of CAR-T therapy in more indications, promoting China's original cell therapy technology to go global. This collaboration marks a crucial step in the industrialization of non-viral CAR-T therapy.Tongli Haiyuan and BRL Medicine Join Hands to Tackle the Challenges of Cancer Treatment, Offering Better Efficacy and More Accessible Costs, Allowing More Patients to Benefit from Cutting-Edge Cell Therapy Technologies, and Together Writing a New Chapter for China's Innovative Medicines.
About BRL Medicine
BRL Medicine Inc. is committed to becoming a globally leading cell and gene therapy company in the new era of commercial civilization. With the mission of "leading innovation through gene editing technology, developing breakthrough therapies, and benefiting all humanity," BRL Medicine relies on its self-developed center and the "Shanghai Gene Editing and Cell Therapy Research Center" co-built with universities. It has already generated more than 100 patent achievements, with 19 projects undergoing clinical trials in over 20 well-known hospitals. Five projects have been approved for IND, officially entering the registered clinical trial phase, and several other projects are in the IND application stage. Among them, gene-editing treatments for β-thalassemia, non-viral site-specific integration PD1-CAR-T, and UCAR-T 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 six proprietary technology platforms: a gene-editing technology innovation platform, a hematopoietic stem cell platform, a non-viral targeted integration CAR-T platform, a universal cell platform, an enhanced T-cell platform, and an in vivo gene-editing CAR-T platform. The company owns a 7,000-square-meter GMP pilot production base and an operational team of nearly 100 people, effectively ensuring that innovative research results can be quickly transformed and applied. BRL Medicine continuously drives the rapid updating and iteration of its R&D products based on patient needs and clinical feedback. With an attitude of openness, sharing, and win-win cooperation, BRL Medicine is working with global innovative biopharmaceutical ecosystem companies to accelerate the transformation and implementation of innovative drugs, benefiting patients worldwide who suffer from genetic diseases, malignant tumors, and autoimmune disorders!
About Tongli Haiyuan
Beijing TONGLI HAIYUAN BIOTECH CO., LTD., Focus on Cell and Gene Therapy（CGT）GMP-grade raw material reagent research, development and production, providing comprehensive product and service solutions for CGT users. Products include cell sorting magnetic bead reagents, recombinant human proteins, serum-free culture media, and cell culture kits. The company has built a 3400m² R&D laboratory and GMP-grade cleanroom production facility, including a cell sorting magnetic bead development platform, eukaryotic and prokaryotic protein expression engineering platforms, and a serum-free culture medium development platform. It has passed dual quality system certifications of ISO13485 and ISO9001, with some products registered with the U.S. FDA DMF.
DianDian "Share”、“Like" and "In Progress", give me a little recharge~"