Shenzhen Pregene Biopharma Co., Ltd (“Pregene”) independently developed BCMA-targeted chimeric antigen receptor T-cell injection. While advancing smoothly in the indication of multiple myeloma, earlier this month, the product obtained NMPA approval for a new clinical trial indication of refractory lupus nephritis. On March 25, 2026, the company again received clinical trial approval notices issued by the National Medical Products Administration (NMPA). The application for two new clinical trial indications of the product, namely refractory IgG4-related disease (Acceptance No. CXSL2501171) and refractory primary immune thrombocytopenia (Acceptance No. CXSL2501170), was approved simultaneously.

About BCMA-targeted Chimeric Antigen Receptor T-cell Injection

BCMA-targeted chimeric antigen receptor T-cell injection is a CAR-T cell drug targeting BCMA independently developed by Pregene, incorporating a chimeric heavy-chain variable domain with high affinity and high specificity. Relevant research data, production processes, and quality control systems of the product are developed to international standards. The project features high production efficiency, significant cost advantages, and reproducible and stable processes and quality control systems.

About Refractory IgG4-related Disease

IgG4-related disease (IgG4-RD) is an immune-mediated chronic inflammatory and fibrotic disease that can affect multiple sites throughout the body. Most patients present with elevated serum IgG4 levels, and abundant infiltration of IgG4-positive plasma cells and fibrosis can be observed in affected organ tissues.

The exact etiology and pathogenesis of IgG4-RD remain unclear. Markedly elevated serum IgG4 levels and mass-like lesions are the most common clinical manifestations. IgG4-RD can involve multiple organs and tissues, with persistent progression or recurrent episodes. Mass-like lesions and persistent immune inflammation-induced fibrosis may cause compression and irreversible damage to affected organs and surrounding tissues, even leading to organ failure.

About Refractory Primary Immune Thrombocytopenia

Primary immune thrombocytopenia (ITP) is caused by the loss of immune tolerance to self-platelet antigens, resulting in immune-mediated increased platelet destruction (mainly via the spleen and mononuclear phagocyte system), as well as immune-mediated megakaryocyte maturation and platelet production disorders, thereby leading to reduced platelet counts.

About Pregene

Shenzhen Pregene Biopharma Co., Ltd has renowned institutional investors as its shareholder, including National Small and Medium-sized Enterprise Development Fund, Guokegahe Fund under the Chinese Academy of Sciences, Shenzhen Capital Group, Haier Biomedical and Huapont Life Sciences. The company focuses on the R&D and promotion of cell and gene therapy drugs and participated in drafting the national drug standard "Key Points to Consider in the Quality Control Testing and Non-clinical Evaluation of CAR-T Cells" issued by the National Institutes for Food and Drug Control in June 2018. Pregene has completed a series of process development for multiple cutting-edge projects such as universal CAR-T, dual-target CAR-T, TCR-T, mRNA, and stem cells. Other product pipelines for cancer, autoimmune diseases and other indications have developed in steps, providing richer technology reserve and broader development prospect to the company.