Rui Therapeutics Presents Long-Term Efficacy and Safety Data of Allogeneic CD19 CAR-NK Therapy KN5501 in Refractory SLE at APLAR 2025

The Most Influential Rheumatology Academic Conference Globally——27th SessionAsiaTooThe Asia-Pacific League of Associations for Rheumatology Congress (APLAR 2025) was grandly held in Fukuoka, Japan, from September 3 to 7.Asia-PacificThe annual flagship conference of the Asia-Pacific League of Associations for Rheumatology (APLAR), this year's event has attracted top experts and scholars mainly from across Asia.Including frontline clinicians, pioneers of biotech innovator companies, and elites from the investment community, focusing on the latest research progress and clinical transformation achievements in rheumatic immune diseases for in-depth exchange and discussion.

A CD19 CAR-NK cell therapy (KN5501) developed by the Chinese innovative pharmaceutical company Rui Therapeutics, in collaboration with the Rheumatology and Immunology Department of Shanghai Changhai Hospital, has demonstrated exciting long-term efficacy of up to 2 years and excellent safety in treating relapsed/refractory systemic lupus erythematosus (SLE), becoming one of the most eye-catching highlights at the conference.

Rheumatology and Immunology Department, Shanghai Changhai HospitalDepartmentDirector Zhao Dongbao、Director Gao Jie and Dr. Qian Hao, CEO of Shenzhen Rui Therapeutics, presented the team's report on "Allogenic CD19 CAR NK Cell Therapy in Refractory Systemic Lupus Erythematosus-A Case Series Study"Latest Clinical Research Follow-up Results of Rui Therapeutics."

At this year's APLAR annual meeting, Rui Therapeutics announced the latest 2-year follow-up results of the CAR-NK therapy for systemic lupus erythematosus (SLE). This study has completed the enrollment and treatment of 27 participants, including 16 SLE patients with severe kidney involvement, and 8 patients with severe hematological system involvement who were unresponsive to multiple immunosuppressants and biologics. According to the SRI, LLDAS, and Doris (2021) remission criteria, among the 20 participants followed up for over 12 months, the SRI-4 response rate was 95%, the LLDAS response rate was 70%, and the Doris remission rate was 60%. Participants achieving Doris remission have been followed up for over 24 months without relapse. All participants showed significant and sustained improvement in SLEDAI and PGA scores, with no cases of recurrence.

The latest 2-year follow-up data of KN5501, presented at the APLAR 2025 conference, confirmed that this CD19 CAR-NK cell therapy demonstrated sustained clinical efficacy and excellent safety profiles in patients with moderate to severe active relapsing/refractory systemic lupus erythematosus (SLE), marking a significant breakthrough in the field of SLE treatment.

About KN5501 

KN5501 is a CAR-NK cell therapy drug developed by Shenzhen Rui Therapeutics, targeting the CD19 antigen to achieve CD19-directed effects.⁺ Deep B-cell depletion induces the reconstruction of the subject's immune system, achieving deep or complete disease remission and enabling patients to discontinue long-term hormone and immunosuppressant treatments. This drug utilizes the unique HTAS-RV™ delivery system and NK cell expansion cryopreservation technology, featuring "universal" and "off-the-shelf" characteristics.

About Rui Therapeutics

Rui Therapeutics was founded in 2021 as a platform company focused on the research and development of next-generation I&I drugs. Since its establishment, the team has been committed to innovating proprietary core technologies. Rui Therapeutics has built a leading CAR-NK technology platform in the I&I field and has also created a universal...ex vivoCAR-T and TCE multi-antibody platforms. The company focuses on inventive innovation, establishing core technologies with independent intellectual property rights, and has laid out cutting-edge First-in-class pipeline products, covering disease areas such as autoimmune diseases, inflammatory conditions, and fibrosis where clinical needs remain unmet.

The success of biopharmaceutical companies hinges on innovation, with the key factors being pharmaceutical concepts and clinical timelines. 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 I&I field.

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