RuiTherapeutics' Off-the-Shelf CD19 CAR-NK Therapy for Systemic Lupus Erythematosus Named One of the 'Top 10 Global Clinical Breakthroughs of 2025'

On December 24, 2025, the annual authoritative selection by "Medicine World""Top Ten Global Clinical Breakthroughs"Officially announced.Rui TherapeuticsUniversally DevelopedCD19 CAR-NK (Chimeric Antigen Receptor Natural Killer Cells)Therapy, with its milestone achievements in the treatment of Systemic Lupus Erythematosus (SLE),Successfully selected for the list. This groundbreaking research was previously published in the prestigious international medical journal The Lancet, marking a new dawn of potential cure for approximately 8 million patients with systemic lupus erythematosus worldwide.

In 2025, global medical advancements have been remarkable. The "Top Ten Clinical Breakthroughs" of the year, selected by the "Medical Community," focus on revolutionary progress that combines scientific innovation with clinical value, injecting new hope for human health.

Systemic lupus erythematosus is a serious autoimmune disease, often referred to as the "never-ending cancer," and is particularly prevalent among women aged 15-45. The patient's immune system mistakenly attacks multiple organs and tissues, causing long-term suffering and endangering life.

Although existing treatments can partially control symptoms, more than half of patients experience recurrent episodes. Long-term use of hormones may also lead to serious side effects such as avascular necrosis of the femoral head and diabetes. The previously highly anticipated CAR-T therapy, despite showing potential for a cure, involves complex preparation and exorbitant costs due to its "personalized customization," and carries risks like cytokine storms and infections, making it difficult to benefit patients on a wide scale.

Rui Therapeutics' research team has successfully developed a universal CD19 CAR-NK cell drug, KN5501, through continuous efforts, fundamentally resolving existing treatment challenges:

• PrecisionTargeted, ImmunotherapyReset: Through genetic engineering modifications, NK cells derived from healthy donors are equipped with a "navigation system" that can precisely identify and eliminate pathogenic B cells responsible for lupus, while simultaneously achieving an "immune system reset" to rebuild a normal immune function network.

• Safe and controllable, with excellent tolerabilityClinical studies have shown that, among 18 patients with moderate to severe refractory conditions who received the treatment, only one experienced a brief low-grade fever. No severe adverse events such as neurotoxicity or infection occurred, completely avoiding the high-risk隐患 of CAR-T therapy.

• Spot available, cost significantly reduced: Unlike the "personalized preparation" of CAR-T, this therapy can be mass-produced in advance, like standardized medical consumables that are ready to use, and is expected to reduce the treatment cost to one-tenth of that of autologous CAR-T.

This global first systematic clinical study, supported and led by Rui Therapeutics, has achieved exciting results: Six months after treatment, all patients had their conditions effectively controlled, with 13 maintaining low disease activity and 10 achieving complete clinical remission; among the 9 patients followed up for over a year, 67% continued to remain in complete remission or low activity, with no cases of recurrence.

▲ Prof. Zhao Dongbao/Gao Jie's team publishes significant research findings in The Lancet 

More notably, a patient with both conditions experienced simultaneous improvement in both systemic sclerosis and the treated disease after receiving this therapy, paving a new path for cross-disease treatment.The Lancet's accompanying commentary highly praised: "This marks an important step forward for CAR cell therapy in the field of autoimmune disease translation.", confirming its key breakthrough in achieving "off-the-shelf" cell therapy.

Rui Therapeutics' Universal CAR-NK Therapy Opens New Avenues for Treating Systemic Lupus Erythematosus and a Broader Range of Autoimmune Diseases. The company will continue to advance relevant clinical research and industrialization processes, accelerating the delivery of this groundbreaking therapy to patients in critical need worldwide.

About Rui Therapeutics

Rui Therapeutics, established in 2021, is a platform-based company focusing on the research and development of next-generation innovative drugs. Since its founding, the team has been committed to innovating proprietary core technologies. Rui Therapeutics has built a leading technology platform in the I&I field based on CAR-NK, while also creating an in vivo CAR-T and TCE multi-antibody platform. The company focuses on invention and innovation, establishing proprietary core technologies, and has laid out cutting-edge First-in-class pipeline products covering disease areas with unmet clinical needs such as autoimmune diseases, inflammatory diseases, and fibrosis. The success of biopharmaceutical companies hinges on invention and creation, with pharmaceutical concepts and clinical timelines being key. Over the past four years, Rui Therapeutics has built an innovative R&D team, an efficient CMC team, and a highly-executive clinical and regulatory affairs team.   

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