On August 13, 2025, QIHAN BIOTECH announced that its off-the-shelf dual-target CAR-T product, QT-019B, received FDA approval for clinical trials, marking the first Chinese-developed universal CAR-T therapy for autoimmune diseases to achieve this milestone.
 

QT-019B, an allogeneic CAR-T product targeting CD19 and BCMA, uses multi-gene editing to reduce immunogenicity and graft-versus-host disease (GvHD) risks. CATUG supported this project by delivering high-standard mRNA for gene editing, meeting international regulatory requirements.
 

CATUG optimized templates, transcription, and purification for complex gene-edited sequences, achieving 95% plasmid purity, >90% mRNA integrity, >95% capping efficiency, and 0.003% residual dsRNA. These metrics ensured regulatory compliance and supported QT-019B’s progress.
 

As a CRDMO, CATUG offers end-to-end services from plasmid preparation to LNP delivery, with GMP-compliant systems meeting FDA/EMA/NMPA standards. This collaboration highlights CATUG’s mRNA expertise and the CDMO model’s role in advancing global therapies.
 

CATUG is committed to partnering globally, using high-quality systems and scalable production to bring innovative therapies from China to the world.
 

About QT-019B
 

QT-019B, developed by QIHAN BIOTECH, is an off-the-shelf allogeneic CAR-T therapy derived from healthy donor leukocytes, expressing CARs targeting CD19 and BCMA. Gene knockouts eliminate TCR expression to reduce GvHD, while multi-gene editing lowers immunogenicity to minimize immune rejection.
 

About QIHAN BIOTECH
 

QIHAN BIOTECH leverages high-throughput gene editing for cell therapies and organ transplantation, aiming to deliver immune-compatible solutions globally. It has one product approved for clinical trials by China’s NMPA and another by the FDA.