RuShun Bio's RJMty19, the World’s First Off-the-Shelf Allogeneic CAR-DNT Therapy for Refractory Systemic Lupus Erythematosus, Granted IND Approval in China

Systemic Lupus Erythematosus (SLE) is a chronic inflammatory autoimmune disease mediated by immune complexes formed by autoantibodies. The estimated incidence rate in China is 8.57 (8.37~8.77) per 100,000 person-years. Currently, SLE remains incurable in clinical practice. Once afflicted, most patients require long-term or even lifelong medication, and some cases can be severe, significantly impacting the quality of life and even threatening the patient's life. Therefore, there is an urgent clinical need for effective treatment methods.

In recent years, B-cell depletion therapy has been widely used in the treatment of autoimmune diseases. Clinical studies both in China and abroad have reported that autologous CAR-T cells (chimeric antigen receptor T cells) targeting CD19 can specifically bind to the CD19 antigen on the surface of B cells, eliminating B cells through antibody-dependent or complement-dependent cytotoxicity. This subsequently reduces the levels of inflammatory mediators in the body, exerts a specific immunosuppressive therapeutic effect, and effectively treats autoimmune diseases such as systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and idiopathic inflammatory myopathies (IIM).

To address the shortcomings of autologous CD19-CAR-T cell therapy products, such as long manufacturing cycles, high costs, and inability to be used immediately, Zhejiang Ruishun Biotech Co., Ltd. has developed an off-the-shelf universal RJMty19 injection. This product has demonstrated excellent safety and preliminary efficacy data in investigator-initiated clinical studies for the treatment of B-NHL, and its clinical efficacy in treating refractory SLE is highly anticipated.

The application for the treatment of refractory SLE with RJMty19 Injection has received the CDE’s tacit approval for clinical trials, marking that RJMty19 Injection, as the world's first off-the-shelf universal CD19-CAR-DNT immune cell therapy product without gene editing, will provide a new therapeutic option for SLE patients who currently have no curative treatments available in clinical practice.

RJMty19 Injection (with the active ingredient being CD19-CAR-DNT cells) is a globally innovative, off-the-shelf, universal second-generation DNT cell therapy product developed by Zhejiang Ruishun Biotech Co., Ltd., based on a global patent for humanized CD19-CAR. Compared with the seven currently marketed autologous CD19-CAR-T cell therapy products, CD19-CAR-DNT cells derived from healthy donors offer numerous advantages such as standardized preparation, lower production costs, and immediate availability for patients. This product holds immense potential in the future market and could fundamentally transform the current commercialization challenges faced by autologous CAR-T cell products.

Currently, this product is used for the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma.（Application No.: CXSL2300725）And Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia(Application No.: CXSL2300853)The IND applications for the other two indications are also under technical review at the Center for Drug Evaluation (CDE) of the National Medical Products Administration.

Zhejiang Ruishun Biotech Co., Ltd. envisions "caring for life and benefiting humanity" and is on a mission to "develop innovative cellular medicines affordable to the common people." The company focuses on developing off-the-shelf, universal immune cell products centered around the DNT cell technology platform. As the pioneer of DNT cell immunotherapy globally, it has developed multiple off-the-shelf, universal cell therapy products based on the DNT cell technology platform, including RC1012 Injection and RJMty19 Injection. Currently, the company is conducting two registered IND clinical trials and three investigator-initiated clinical trials targeting hematological malignancies.