Rui Therapeutics Presents Promising Long-Term Data of Allogeneic CD19 CAR-NK Therapy KN5501 in Refractory SLE and Systemic Sclerosis at EULAR 2025

The Most Influential Rheumatology Academic Conference Globally——2025Annual European Congress of Rheumatology（EULAR 2025）It was held in Barcelona, Spain from June 11 to 14. As the European League Against Rheumatism（EULAR）Annual Flagship Conference, This Year's CongressThe number of participants reached 13,000.Person, meanwhileAttractExperts and scholars from all over the world, including frontline clinicians and pioneers of biotech innovator companiesAnd investment elites, engage in in-depth exchange and discussion on the latest research progress and clinical transformation achievements in rheumatological and immunological diseases.

A project by a local innovative pharmaceutical companyShenzhen Rui TherapeuticsR&D,Department of Rheumatology and Immunology, Shanghai Changhai HospitalLeading CD19 CAR-NK Cell Therapy（KN5501）Clinical Research, in TreatmentRelapsed/Refractory Systemic Lupus Erythematosus（SLE）Showed exciting long-term efficacy and excellent safety, becoming one of the most eye-catching highlights of the conference.

Professor Kong Ruina, representing the team led by Professors Zhao Dongbao and Gao Jie from the Rheumatology and Immunology Department of Shanghai Changhai Hospital, a clinical center collaborating with Rui Therapeutics, presented the report.「Allogenic CD19 CAR NK Cell Therapy in Relapse or Refractory Systemic Lupus Erythematosus」The latest clinical research follow-up results.

At this year's EULAR conference, Rui Therapeutics announced the latest follow-up results of its CAR-NK therapy for systemic lupus erythematosus. This study has completed the enrollment and treatment of 27 participants, including 16 cases of systemic lupus erythematosus.（SLE）The subjects had severe involvement of the renal organ system, and 8 subjects had severe involvement of the hematologic system, with no response to multiple immunosuppressants and biologics. According to SRI, LLDAS, and Doris(2021) Remission Criteria: Among the 13 subjects followed up for more than 12 months, the SRI-4 response rate was 100%, the LLDAS response rate was 76.9%, and the Doris remission rate was 69.2%. The longest follow-up time for subjects achieving Doris remission exceeded 21 months, with sustained remission and no recurrence. All subjects showed significant and continuous improvement in SLEDAI-2K and PGA scores, with no recurrence observed in any subject.

At the same time, the team disclosed for the first time the clinical research progress of KN5501 in treating systemic sclerosis: six patients with systemic sclerosis who received CAR-NK therapy showed positive clinical benefits during a 9-month follow-up period, including the American College of Rheumatology Combined Response Index in Systemic Sclerosis.（ACR-CRISS）, Modified Rodnan Skin Score（mRSS）Significant improvement.

Latest Long-term Follow-up Data of KN5501 Presented at EULAR 2025 Confirm Durable Clinical Efficacy and Excellent Safety Profile of the CD19 CAR-NK Cell Therapy in Patients with Moderate to Severe Active Relapsing/Refractory Systemic Lupus Erythematosus, Marking a Significant Breakthrough in SLE Treatment. Positive Efficacy of KN5501 in Systemic Sclerosis Also Disclosed for the First Time.

KN5501 is a CAR-NK cell therapy drug developed by Shenzhen Rui Therapeutics, targeting the CD19 antigen. It aims to achieve deep depletion of CD19+B cells by targeting the CD19 antigen, inducing immune reconstitution in subjects, enabling patients to discontinue long-term hormone and immunosuppressant treatments, and achieving long-term deep or complete remission of the disease. The drug utilizes a unique HTAS-RV™ delivery system and NK cell expansion and cryopreservation technology, featuring "universal" and "off-the-shelf" characteristics.

Rui Therapeutics（Rui Therapeutics）Founded in 2021, Rui Therapeutics is a platform company focused on the research and development of a new generation of universal cell-based therapeutics. Since its establishment, the team has been committed to innovating proprietary core foundational technologies. Rui Therapeutics has built a leading technology platform in the field of next-generation universal cell therapy, with CAR-NK at the forefront. The company emphasizes inventive innovation and has developed proprietary core technologies in CAR structure design, the HTAS-RV™ viral delivery system, and anti-HvG strategies. Currently, the company has laid out a cutting-edge First-in-class pipeline, targeting unmet clinical needs in autoimmune diseases, inflammatory conditions, fibrosis, and anti-aging.

The success of biopharmaceutical companies hinges on innovation, with pharmaceutical concepts and clinical timelines being crucial. Over the past four years, Rui Therapeutics has built an innovative R&D team, an efficient CMC team, and a highly capable clinical and regulatory affairs team.

Rui Therapeutics will further strengthen the innovation of core technologies, the upgrading of pipeline products, the expansion of clinical indications, and international cooperation, consolidating its leading position and cutting-edge exploration in the field of autoimmune diseases.

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