Rui Therapeutics Announces CDE Clearance of IND Application for KN5501, a First-in-Class Off-the-Shelf CD19-Targeted CAR-NK Cell Therapy for Refractory Systemic Lupus Erythematosus

On September 4, Rui Therapeutics (Shenzhen)(hereinafter referred to as "Rui Therapeutics")Submission of KN5501 Cell Injection for New Drug Clinical Trial（IND）Application for Approval from the Center for Drug Evaluation of the National Medical Products Administration（CDE）Tacit consent.

KN5501 is a CAR-NK cell therapy drug developed by Rui Therapeutics based on the CD19 target, aiming to achieve CD19 targeting through the CD19 target.⁺Deep depletion of B cells induces autoimmune reconstitution in subjects, achieving deep or complete disease remission and enabling subjects to discontinue long-term hormone and immunosuppressant treatments. This drug utilizes the unique HTAS-RV™ delivery system and CAR-NK cell expansion cryopreservation technology, featuring "universal" and "off-the-shelf" characteristics.The approved clinical trial is an open, single-arm, dose-escalation Phase I clinical trial, aimed at evaluating the KN5501 cell injection in relapsed and refractory systemic lupus erythematosus.（SLE）The safety, tolerability, pharmacokinetics, and efficacy in subjects. Currently, no CAR-NK cell drugs with the same target have been approved for marketing in China or globally, and the development of KN5501 is at the international forefront.

KN5501 Cell Injection Receives Clinical Trial Approval from CDE, Marking a Significant Milestone. This means we can bring universal CAR-NK cell therapy to Chinese SLE patients more quickly. We will fully accelerate the enrollment of SLE patients, promptly initiate and complete the registration clinical trial, to meet commercialization needs as soon as possible. Our goal is to deliver this innovative, breakthrough, and accessible cell therapy to a wide range of patients, fundamentally alleviating their suffering, improving their quality of life, and restoring hope for health.