Bennu Bio Achieves First-in-China CAR-Treg Cell Infusion with BEN301, Marking a Milestone in Autoimmune Disease Therapy

Recently, in Shanghai, China, Binuoji Biologics (hereinafter referred to as “Binuoji” or the “Company”), a company focused on developing innovativeTAn innovative biopharmaceutical company specializing in cell therapies for the treatment of cancer and inflammatory and immune-mediated diseases announced today that its independently developedYesAutoimmune DiseasesCAR-Treg Cell Therapy Drugs—BEN301The product has successfully completed the first patient infusion in China.This is ChinaHistoric Breakthrough of CAR-Treg in Autoimmune Diseases Marks a Key Step for China in the Clinical Translation of Regulatory T Cell (Treg) Immunotherapy, marking a milestone.

RegulatoryT cells（Treg）Yes2025 Nobel Prize in Physiology or Medicine LaureateShimon SakaguchiFindingsandDefinitionof，HeRevealing its role in preventing the immune system from attacking the body's own tissues, pioneering Treg CellIntroductionInduced peripheral immune tolerance: a new frontier.However, over the past three decades,Treg cells have not yet beenSuccessfully formulated into a product for the treatment of immune-mediated diseases.

This infusion was administered in an investigator-initiated clinical trial (IIT) framework, focusing on the exploration of treatments for autoimmune diseases in the rheumatology and immunology department. Indications include systemic sclerosis (scleroderma, SSc), rheumatoid arthritis (RA), primary Sjögren's syndrome (pSS), and dermatomyositis (DM）。As a novel class of cell therapy, CAR-Treg differs from conventional cytotoxic CAR-T cells. Its core mechanism involves genetically engineering the patient’s autologous regulatory T cells to precisely suppress aberrant immune responses and restore immune tolerance, thereby offering advantages over traditional cytotoxicCAR-TDifferent, no cytokinesRelease Syndrome（CRS)andImmune Effector Cell-Associated Neurotoxicity Syndrome ((ICANS), CAR-Treg cells offer a superior safety profile, providing a novel therapeutic pathway for refractory autoimmune diseases that have long posed clinical challenges.

The successful reinfusion of the first patient in this trial marks Binuoji’sKey Milestone in the Transition of the CAR-Treg Pipeline from Preclinical Research to Clinical Application. The company has established a fully autonomous, end-to-end technical system encompassing vector design, cell manufacturing, quality control, and clinical administration, strictly adhering to GMP standards and ethical requirements for clinical research to ensure the safety, stability, and accessibility of the cell therapy product. To date, patient infusions have proceeded smoothly with favorable outcomes, and follow-up visits and safety assessments will be conducted in accordance with the study protocol.

BinuojiCEO Dr. Sui stated:“We are delighted to announce CAR-Treg”BEN301The product in investigator-initiated clinical trials ((IIT) completed the first infusion of a study participant. CAR-Treg cell therapy represents a significant direction for next-generation immunotherapy, holding immense potential especially in diseases characterized by “immune imbalance.” The completion of this first domestic infusion not only validates our R&D strategy but also lays a solid foundation for future clinical studies. This milestone serves as both a validation of Bionorace’s technology platform and a significant advancement in China’s cell therapy field. We extend our gratitude to the clinical team, investigators, and patients for their trust. We will steadily advance subsequent clinical trials, striving to bring safe and effective innovative therapies to patients at the earliest possible date.”