On September 19, 2024, Chongqing Precision Biotech’s MC-1-50 cell preparation received official recognition  by the Center for Drug Evaluation (CDE) for a new indication . This new use is for treating adult patients with refractory systemic lupus erythematosus (SLE). This indication marks the company’s first innovative drug application in the field of autoimmune diseases, providing a new treatment option for patients with adult refractory systemic lupus erythematosus (SLE).

systems. It severely impacts the health and quality of life of millions in China, especially women in their childbearing years, typically between 20 and 40 years old. Traditional treatments aim to control the disease’s progression, alleviate symptoms, and reduce the frequency of relapses. However, only less than 1% of patients achieve complete remission without medication, and these treatments can cause significant side effects. The emerging application of CAR-T therapy in the autoimmune field holds promise as a crucial treatment option for SLE, potentially improving the challenging treatment landscape for these patients.

MC-1-50 is a second-generation CD19-targeted CAR-T cell therapy developed independently by the company based on the PRIMCAR® platform. It represents a novel, faster, and more effective CAR-T preparation method, with the product featuring lower dosages, fewer side effects, and longer persistence. The autoimmune indication for MC-1-50 marks the third application of this therapy, following its use for B-cell acute lymphoblastic leukemia and non-Hodgkin’s lymphoma.

MC-1-50 is currently being studied in an Investigator-Initiated Trial (IIT) for the treatment of patients with refractory SLE. Two patients who have completed the cell infusion have achieved DORIS remission (a SLE Disease Activity Index score of 0) at 2 and 6 months post-infusion, respectively. Importantly, these two patients have not required any further SLE treatment medications, such as hormones or immunosuppressants. Both patients experienced only grade 1 cytokine release syndrome (CRS), fully demonstrating the excellent safety, efficacy, and durability of the CAR-T cells produced by the PRIMCAR® platform.This breakthrough offers hope for a potential cure for all SLE patients.

Autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA), and Antiphospholipid Antibody Syndrome (APS), rank second only to cancer as the largest disease category globally, offering immense opportunities. In 2023, three of the world’s top ten best-selling pharmaceuticals were drugs for autoimmune diseases. Forecasted by Frost & Sullivan, the global market for autoimmune disease medications is expected to reach $176 billion by 2030. In China, the market for such drugs is anticipated to reach $25 billion, making it a significant contributor to the global market for autoimmune disease treatments.